[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tasly Pharmaceutical Group Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":368},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,42,62,84,106,128,149,174,198,220,242,262,286,308,329,349],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100630278","phase-2-a-study-of-the-effectiveness-and-safety-of-js1-1-01-tablet-in-patients-with-moderate-to-severe-depression-100630278",false,"NCT07485595","A Study of the Effectiveness and Safety of JS1-1-01 Tablet in Patients With Moderate to Severe Depression","A Phase 2\u002FPhase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness and Safety of JS1-1-01 Tablet in Patients With Moderate to Severe Depression","Inclusion Criteria:\n\n1. Age range from 18 to 65 years old (including boundary values), both male and female;\n2. Single or recurrent episodes that meet the diagnostic criteria for depression in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition);For patients with a single episode, the duration of this depressive episode must be ≥90 days.\n3. Screening and baseline periods, the total score of the Montgomery Asperger Depression Rating Scale (MADRS) was ≥ 26 points;\n4. Screening and baseline periods, with a Clinical Global Impression Scale Disease Severity (CGI-S) score of ≥ 4 points;\n5. Voluntary participation in clinical trials, able to sign informed consent forms, and able to understand and comply with research procedures.\n\nExclusion Criteria:\n\n1. Individuals with a history of severe drug allergies or allergies to Piper Piper (pepper plant) ;\n2. Those who have used at least two antidepressants in sufficient dosage and duration (treated according to the maximum dosage in the instructions for at least 4 weeks) in a single or current episode in the past but still have no effect;\n3. The patients of depression secondary to other mental or physical illnesses;\n4. Patients of depression with accompanying psychiatric symptoms;\n5. Significant suicidal attempt or behavior within the past year, with a score of ≥ 3 on the 10th item (suicidal ideation) of the MADRS scale;\n6. Individuals with a history of epileptic seizures (excluding convulsions caused by febrile seizures in children);\n7. Individuals who have received depression related systemic physical therapy within 3 months prior to their first administration: modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), phototherapy, or systemic psychotherapy;\n8. Systematically receiving antidepressant treatment within the first 2 weeks of randomization, or discontinuing antidepressant medication for less than 5 half-lives before randomization;\n9. Those with severe unstable cardiovascular and cerebrovascular diseases, respiratory system diseases, gastrointestinal diseases, liver diseases, kidney diseases, blood diseases, endocrine diseases, or a history of such physical diseases;\n10. Accompanied by a history of malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ);\n11. Screening or baseline electrocardiogram abnormalities that have clinical significance and are deemed unsuitable for inclusion by investigators, such as male QTcF ≥ 450 ms, female QTcF ≥ 470 ms, or having a history of long QT syndrome;\n12. During the baseline period, those with a reduction rate of ≥ 25% in the MADRS scale score compared to the screening period;\n13. A history of symptomatic orthostatic hypotension (i.e. orthostatic syncope) with clinical significance;\n14. During the screening or baseline period, TBIL is above 2 times the upper limit of normal value, and ALT or AST is above 2 times the upper limit of normal value; Cr is higher than 1.2 times the upper limit of normal value;\n15. Thyroid dysfunction (TSH above 1.2 times the upper limit of normal value or below 0.8 times the lower limit of normal value) or the presence of hyperthyroidism or hypothyroidism determined by the investigators; Individuals with a history of elevated intraocular pressure or narrow angle glaucoma;\n16. Screening period, drug abuse screening positive individuals;\n17. A history of alcohol dependence within one year prior to screening(Drinking alcohol for more than 5 years, equivalent ethanol intake, daily alcohol consumption: men \\>40 g\u002Fd, women \\>20 g\u002Fd; drinking ≤5 years, equivalent ethanol intake, history of heavy drinking (\\>80 g\u002Fd) within 2 weeks);\n18. Pregnant and lactating women, male or female subjects who have a family planning or are unable to take effective contraceptive measures within 30 days after signing the informed consent form and ending the trial;\n19. Screening for individuals who have participated in clinical trials and taken investigational drugs within the first 30 days;\n20. The investigators believe that the subjects have poor compliance or there are other clinical, social, or family factors that are not suitable for enrollment.","ALL","18 Years","65 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","The purpose of this study is to evaluate the Effectiveness and Safety of JS1-1-01 Tablet in Patients With Moderate to Severe Depression",[28],"Depression","NOT_YET_RECRUITING","2026-04-02",{"date":32,"type":33},"2026-04-08","ACTUAL",{"date":35,"type":21},"2026-04-30",{"date":37,"type":21},"2026-12-31",{"name":39,"class":40},"Tasly Pharmaceutical Group Co., Ltd","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":59,"leadSponsor":61,"locationsCount":41},"100613682","phase-3-a-clinical-trial-evaluating-the-efficacy-and-safety-of-sanhuang-jingshiming-pills-in-the-treatment-of-namd-100613682","NCT07269769","A Clinical Trial Evaluating the Efficacy and Safety of Sanhuang Jingshiming Pills in the Treatment of nAMD","A Phase III , Randomized, Double-blind, Placebo-Controlled, Ranibizumab Injection Loading, Multicenter Clinical Trial Comparing the Efficacy and Safety of Sanhuang Jingshiming Pills in Subjects With nAMD","Inclusion Criteria:\n\n1. Aged 50 to 85 years old (inclusive of 50 and 85 years old)\n2. Meets the Western medical diagnostic criteria for neovascular age-related macular degeneration\n3. Meets the TCM syndrome differentiation criteria for Qi-Yin Deficiency with Phlegm-Blood Stasis Intermingling Syndrome\n4. The study eye is diagnosed with nAMD and the disease is in the active phase\n5. BCVA of the study eye assessed by the ETDRS visual acuity chart ranges from 25 to 78 letters\n6. Voluntarily participates in the clinical trial, signs the ICF, and is able to understand and comply with the trial procedures\n\nExclusion Criteria:\n\n1. The study eye is complicated with pathologic myopia, high myopia, or secondary MNV caused by other definite diseases, glaucoma, diabetic retinopathy , retinal artery\u002Fvein occlusion , optic neuropathy (optic neuritis, optic atrophy, papilledema), macular hole, acute phase of intraocular inflammation, or other ocular diseases\n2. Patients with pure PED in the study eye\n3. Patients with subfoveal structural destruction or subfoveal fibrosis\u002Fscars\u002FRPE tear\u002FGA in the study eye\n4. Patients whose FP of the study eye shows a total macular lesion area \\> 9 disc areas (total lesion area is defined as the sum of the areas of MNV, atrophy, scars, and fibrosis); or patients whose FP of the study eye shows a maximum macular hemorrhage area \\> 4 disc areas\n5. Patients with CRT ≥ 700 μm in the study eye as assessed by OCT\n6. Patients with opaque refractive media (e.g., vitreous hemorrhage, cataract) in the study eye precluding adequate visualization of the fundus, or with a history of vitrectomy\n7. Patients planning to undergo any intraocular surgery on the study eye during the trial period\n8. Patients who received pharmacologic treatment for nAMD within 2 weeks prior to randomization\n9. Patients who received intravitreal anti-vascular endothelial growth factor therapy on the study eye within 4 months prior to randomization\n10. Patients who received photodynamic therapy , laser photocoagulation, macular surgery, transpupillary thermotherapy , or corticosteroid therapy on the study eye within 6 months prior to randomization\n11. Patients who underwent any intraocular or periocular surgery (excluding eyelid surgery) on the study eye within 3 months prior to randomization\n12. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg while on regular antihypertensive medication)\n13. History of major cardiovascular or cerebrovascular diseases, including but not limited to: ① history of myocardial infarction (MI), coronary angioplasty or bypass surgery, valvular heart disease or valvular repair, clinically significant and treatment-requiring arrhythmia, unstable angina, transient ischemic attack (TIA), cerebrovascular accident (CVA), etc., within 6 months prior to randomization; ② congestive heart failure (CHF) with New York Heart Association (NYHA) classification of Grade Ⅲ or Ⅳ\n14. Laboratory test abnormalities as follows: ① platelet count ≤ 100 × 10⁹\u002FL; ② International Normalized Ratio (INR) ≥ 1.5; ③ total bilirubin (TBIL) \\> 2 × upper limit of normal (ULN); ④ alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2.5 × ULN; ⑤ serum creatinine (Scr) \\> 1.5 × ULN\n15. Patients with severe and unstable diseases of the mental, neurological, respiratory, digestive, renal, metabolic, immune, hematologic, or other systems, as well as malignant tumors, who are assessed by the investigator as unsuitable for participation in this clinical trial\n16. Presence of any contraindications listed in the package insert of ranibizumab injection (Lucentis®) or other anti-VEGF injections\n17. Suspected allergy to any study drug\n18. Pregnant or lactating females; males or females who plan to conceive within 30 days from signing the ICF to the end of the trial, or who cannot use effective contraceptive measures\n19. Participation in another interventional clinical trial within 3 months prior to randomization\n20. Other reasons deemed unsuitable for participation in this clinical trial by the investigator","50 Years","85 Years",{"count":52,"type":21},450,[25],"The purpose of the TSL-TCM-SHJSMW-Ⅲ study is to study the efficacy and safety of Sanhuang Jingshiming Pills in subjects with Neovascular Age-Related Macular Degeneration.",[56],"AMD",{"date":32,"type":33},{"date":35,"type":21},{"date":60,"type":21},"2031-12-31",{"name":39,"class":40},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":83,"locationsCount":41},"100632467","phase-1-tsl2109-capsules-in-advanced-solid-tumor-patients-safety-tolerability-pk-and-preliminary-efficacy-100632467","NCT07514065","TSL2109 Capsules in Advanced Solid Tumor Patients: Safety, Tolerability, PK and Preliminary Efficacy","Multicenter, Dose-Escalation & Dose-Expansion, Single-Arm, Open-Label Phase I Trial: Safety, Tolerability, PK and Preliminary Antitumor Efficacy of TSL2109 Capsules in Advanced Solid Tumor Patients","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically or cytologically confirmed advanced solid tumors, with failure of prior standard therapy, or no available standard therapy, or currently unsuitable for standard therapy, and not amenable to surgery or radiotherapy with curative intent. Priority will be given to patients with metastatic castration-resistant prostate cancer (mCRPC) and HR+\u002FHER2- advanced breast cancer.\n3. (Dose-Escalation Phase) At least one evaluable or measurable tumor lesion per RECIST Version 1.1; (Dose-Expansion Phase) At least one measurable tumor lesion per RECIST Version 1.1 (tumor lesions located in prior radiation fields or other locally treated sites generally do not qualify as measurable lesions unless there is clear progression or persistence three months after radiotherapy).\n4. Life expectancy ≥3 months.\n5. ECOG performance status score of 0 to 1.\n\nMetastatic Castration-Resistant Prostate Cancer (mCRPC):\n\nCastration status at screening: (1) Currently receiving androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist\u002Fantagonist or history of bilateral orchiectomy. (2) Serum total testosterone ≤1.7 nmol\u002FL (50 ng\u002FdL) at screening. Additionally, progression documented by one or more of the following three criteria: ① PSA progression defined as PSA \\>1 ng\u002FmL with two consecutive increases \\>50% from baseline at least 1 week apart; ② Soft tissue disease progression per RECIST 1.1; ③ Bone disease progression per PCWG3, defined as two or more new bone lesions on bone scan. Priority will be given to end-line patients who have received prior androgen receptor inhibitors and have received chemotherapy or are chemotherapy-intolerant or chemotherapy-refusing.\n\nHR+\u002FHER2- Breast Cancer:\n\n① Histologically or cytologically confirmed HR-positive, HER2-negative breast cancer (determined from the most recent tumor sample \\[primary or metastatic\\] with histological confirmation of HR+\u002FHER2- status. To meet HR+ disease requirements, breast cancer must express estrogen receptor \\[ER\\], with or without progesterone receptor co-expression), locally advanced or recurrent\u002Fmetastatic breast cancer in female patients. ② Prior exposure to CDK4\u002F6 inhibitors (e.g., abemaciclib, palbociclib, etc.).\n\nExclusion Criteria:\n\n1. Clinically symptomatic central nervous system (CNS) metastases or leptomeningeal metastases, or other evidence indicating uncontrolled CNS or leptomeningeal metastases, judged by the investigator as unsuitable for enrollment.\n2. Diagnosis of another invasive malignancy within the past 2 years, except for radically treated non-melanomatous skin cancer or superficial urothelial carcinoma, cutaneous basal cell or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, papillary thyroid carcinoma, cervical carcinoma in situ, or breast carcinoma in situ.\n3. Clinically significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, such as inability to take oral medications, uncontrolled nausea or vomiting, history of extensive gastrointestinal resection, unresolved recurrent diarrhea, untreated gastric conditions requiring long-term proton pump inhibitor therapy, Crohn's disease, ulcerative colitis, intestinal obstruction, etc.\n4. Imaging (CT or MRI) showing tumor invasion of major blood vessels (e.g., aorta, pulmonary arteries\u002Fveins, vena cava, etc.) with assessed bleeding risk.\n5. Interstitial lung disease, pneumonitis, or pulmonary fibrosis, assessed by the investigator as unsuitable for enrollment.\n6. History of deep vein thromboembolism.",{"count":70,"type":21},78,[72],"PHASE1","TSL2109 is a novel CDK4\u002F6-DYRK2 dual-target inhibitor developed by Jiangsu Tasly Diyee Pharmaceutical Co., Ltd. for solid tumor treatment. Preclinical studies confirm its selective targeting of CDK4\u002F6 and DYRK2, a eukaryotic CMGC family kinase.\n\nIn palbociclib-resistant cell lines, TSL2109 downregulates cell cycle-related proteins and DYRK2 pathway ribosomal synthesis regulators (RRS1, CDK2), and upregulates p53, thus exerting synergistic antitumor effects and overcoming resistance to enzalutamide and palbociclib.\n\nAs a small-molecule inhibitor with novel targets, structure and mechanism, TSL2109 blocks tumor cell cycle progression independently of hormonal signaling. Preclinical studies show it overcomes AR inhibitor resistance, meeting unmet needs for prostate cancer patients progressing after AR inhibitor therapy. It also reduces CDK2 activity and blocks CDK4\u002F6 compensatory mechanisms, reversing resistance to CDK4\u002F6 inhibitors, providing a new option for HR+\u002FHER2- advanced breast cancer patients.\n\nParticipants Dose-Escalation Phase: Advanced solid tumor patients, prioritizing metastatic castration-resistant prostate cancer (mCRPC) and HR+\u002FHER2- advanced breast cancer.\n\nDose-Expansion Phase:\n\nCohort A\u002FC: mCRPC; Cohort B\u002FD: HR+\u002FHER2- advanced breast cancer. Treatment Regimens C0 Cycle (3 days): Single oral dose on Day 1 morning under fasting, followed by 72-hour observation.\n\nC1 Cycle (28 days): Daily fasting oral dosing (QD) for 3 weeks, then 1-week rest. Participants may continue treatment if no DLT and potential clinical benefit.\n\nDose escalation to a pre-established tolerable level is allowed per investigator-sponsor agreement if well-tolerated and likely beneficial. Treatment continues until disease progression, intolerable toxicity or new antitumor therapy. The Dose-Expansion Phase uses the same regimen as C1.\n\nMissed Dose: Make-up within 8 hours; skip if delayed over 8 hours. Notes: Once MTD is determined, participants dosed above MTD will be adjusted to MTD. All doses are administered orally under fasting conditions.",[75],"Metastatic Castration-Resistant Prostate Cancer Patients","RECRUITING","2026-03-31",{"date":79,"type":33},"2026-04-07",{"date":81,"type":33},"2026-02-20",{"date":37,"type":21},{"name":39,"class":40},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":41},"100617453","phase-1-a-clinical-trial-of-p134-cells-in-recurrent-glioblastoma-100617453","NCT07318818","A Clinical Trial of P134 Cells in Recurrent Glioblastoma","A Phase I\u002FII Clinical Study to Evaluate the Safety and Efficacy of P134 Cells in the Treatment of Recurrent Glioblastoma","Inclusion Criteria:\n\n1. Voluntary written informed consent.\n2. 18-70 years of age (inclusive), male or female.\n3. Recurrent or progressive glioblastoma, histopathologically or molecularly diagnosed consistent with grade 4 glioblastoma (IDH wild-type) (refer to WHO Classification of Central Nervous System Tumors, 5th Edition, 2021).\n4. Positive CD44 or CD133 antigen expression in tumor tissue confirmed by IHC, defined as ≥1% of tumor cells showing positive CD44 or CD133 IHC staining, regardless of intensity (applicable only in Phase II dose expansion study).\n5. At least one measurable lesion meeting RANO 2.0 criteria and having a radiographically assessed measurable lesion ≤ 3 cm in longest diameter\n6. Patient has received prior radiation therapy and\u002For temozolomide\u002Fbevacizumab.\n7. The investigator confirmed that the patient was suitable for craniotomy cerebrospinal fluid shunt and accessory (Ommaya reservoir) implantation.\n\nExclusion Criteria:\n\n1. Highly allergic constitution or history of severe allergy, or allergy to related cell products\n2. Receipt of biologic anti-tumor therapy (including monoclonal or bispecific antibody-targeted therapy, immune checkpoint inhibitor therapy, etc.) within 6 weeks prior to PBMC collection; receipt of radiotherapy or surgery within 4 weeks prior to PBMC collection (excluding placement of vascular access devices; a 1-week washout period is acceptable for diagnostic biopsy surgeries); receipt of chemotherapy, hormone therapy (excluding hormone replacement therapy), or non-specific immunomodulatory therapy (such as interleukins, interferons, thymosin, cyclophosphamide, methotrexate, tumor necrosis factor, etc.) within 2 weeks prior to PBMC collection; receipt of traditional Chinese medicine therapy with a clear anticancer indication within 1 week prior to PBMC collection.\n3. The adverse reactions caused by previous anti-tumor treatment have not recovered to ≤ Grade 1 as evaluated by NCI CTCAE v6.0 (except alopecia, skin pigmentation, leukoplakia, etc. which are assessed as having no safety risk).\n4. Tumor metastasis to the brainstem or spinal cord.\n5. Suffering from other serious neurological diseases other than brain tumors, such as meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome\u002Fmyasthenia gravis, amyotrophic lateral sclerosis, spinal muscular atrophy, nerve paralysis, uncontrolled epilepsy, etc.\n6. Patients with primary immunodeficiency disease, autoimmune diseases requiring medication (such as Crohn 's disease, ulcerative colitis, rheumatoid arthritis, systemic lupus), or previous history of autoimmune diseases of the nervous system (such as multiple sclerosis, Parkinson' s disease).\n7. Receiving or requiring long-term use of immunosuppressive agents (except for physiological doses of systemic corticosteroids ≤ 10 mg\u002Fday prednisone equivalent, short-term ≤ 7 days corticosteroids for allergies, or topical glucocorticoids).\n8. Trial participants who have a previous history of allogeneic bone marrow transplantation or organ transplantation, or are awaiting organ transplantation.\n9. HBsAg positive and HBV DNA positive, HCV Ab positive and HCV RNA positive; Treponema pallidum antibody positive; human immunodeficiency virus (HIV) antibody positive.\n10. Prior receipt of any gene therapy or cell therapy trial participant.\n11. Pregnant or lactating women.\n12. History of malignancy other than glioma within 5 years (except for adequately treated carcinoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, localized prostate cancer, or stage I cervical cancer, which in the opinion of the investigator carries a minimal risk of recurrence).","70 Years",{"count":93,"type":21},26,[72,24],"This is an open-label, single-arm, dose-escalation and expansion Phase 1\u002F2 clinical trial designed to evaluate the safety, tolerability and efficacy of P134 cells in patients with recurrent glioblastoma, to explore the maximum tolerated dose (MTD)and recommended Phase 2 dose (RP2D), and to characterize the cytokinetic profile of CAR-T cells in the cerebrospinal fluid of patients. Eligible participants are adults diagnosed with recurrent or progressive glioblastoma who are confirmed as grade 4 glioblastoma (IDH wild-type) by histopathology or molecular pathology.\n\nP134 cells are CD44\u002FCD133 dual-targeting CAR-T cells developed by the research team led by Academician Jiang Tao and Professor Zhang Wei from the Beijing Neurosurgical Institute and the Department of Neurosurgery, Beijing Tiantan Hospital. This study is spearheaded by Professor Zhang Wei of the Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, China, with scientific oversight and guidance provided by Academician Jiang Tao of the Chinese Academy of Engineering.",[97],"Recurrent Glioblastoma IDH Wildtype","2026-02-13",{"date":100,"type":33},"2026-02-18",{"date":102,"type":33},"2026-01-05",{"date":104,"type":21},"2028-08-31",{"name":39,"class":40},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":41},"100621515","phase-1-a-study-of-the-safety-tolerability-and-preliminary-efficacy-of-b2065-in-patients-with-acute-ischemic-stroke-100621515","NCT07371624","A Study of the Safety, Tolerability and Preliminary Efficacy of B2065 in Patients With Acute Ischemic Stroke.","A Phase I\u002FIIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Allogeneic Adipose-Derived Mesenchymal Stromal Cell Injection (B2065) in Participants With Acute Ischemic Stroke.","Inclusion Criteria\n\n1. Aged 18 to 75 years (inclusive of the boundary values), with no restriction on sex.\n2. Patients with ischemic stroke confirmed by imaging examinations (CT\u002FMRI).\n3. Time from onset of stroke symptoms to administration of the investigational product ≤36 hours; for wake-up stroke, the time of onset is defined as the last-known-well time (the last time the patient was observed to be normal).\n4. NIHSS score at screening is 8 to 20.\n5. The patient or legally authorized representative is willing to participate in this trial and agrees to sign the informed consent form.\n\nExclusion Criteria\n\n1. Patients who have received intravenous thrombolysis and\u002For mechanical thrombectomy prior to dosing.\n2. Modified Rankin Scale (mRS) score ≥2 before stroke onset.\n3. Patients who currently have intracranial hemorrhagic diseases (e.g., intracerebral hemorrhage, epidural hematoma, subarachnoid hemorrhage, etc.), or who have brain tumors, cerebrovascular malformations, multiple sclerosis, a history of severe traumatic brain injury, encephalitis, or other conditions causing stroke-like symptoms.\n4. Patients who are unable to undergo CT and\u002For MRI examinations.\n5. Patients with decreased level of consciousness (NIHSS item 1a score ≥2).\n6. Patients who may have major neurologic or psychiatric disorders that seriously interfere with the participant's compliance with trial assessments.\n7. Body temperature \\>38°C prior to dosing, and the investigator assesses that there is a risk of infection.\n8. Patients with uncontrollable active infection; or patients who have received systemic anti-infective therapy within 7 days prior to dosing and, in the investigator's judgment, may be likely to convert to uncontrollable active infection in the short term.\n9. Patients with current or prior severe diseases of other organ systems, including but not limited to:\n\n   1. Patients with severe heart failure (NYHA Class III or IV) and\u002For severe respiratory failure;\n   2. Patients with renal disease with estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m²;\n   3. Advanced liver disease, such as hepatitis or liver cirrhosis;\n   4. Patients positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg); patients positive for hepatitis B e antibody (HBeAb) and\u002For hepatitis B core antibody (HBcAb) with quantitative HBV-DNA above the upper limit of normal; patients with any of the following test results positive: hepatitis C virus antibody (HCV-Ab), Treponema pallidum antibody (TP-Ab), or human immunodeficiency virus antibody (HIV-Ab);\n   5. Patients with hypertension not controlled after taking therapeutic medications, with systolic blood pressure ≥185 mmHg and\u002For diastolic blood pressure ≥110 mmHg;\n   6. Blood glucose \\\u003C2.8 mmol\u002FL (50 mg\u002FdL) or \\>22.2 mmol\u002FL (400 mg\u002FdL).\n10. Screening laboratory tests meeting any of the following criteria:\n\n    1. Serum alanine aminotransferase (ALT) ≥3× upper limit of normal (ULN);\n    2. Serum aspartate aminotransferase (AST) ≥3× ULN;\n    3. Serum creatinine (Cr) ≥2× ULN;\n    4. Absolute neutrophil count (ANC) \\\u003C1.5×10\\^9\u002FL;\n    5. Platelet count (PLT) \\\u003C100×10\\^9\u002FL;\n    6. Hemoglobin (Hgb) \\\u003C90 g\u002FL;\n    7. International normalized ratio (INR) \\>1.7 or activated partial thromboplastin time (APTT) \\>1.25× ULN.\n11. Patients with malignant tumors or other diseases with an expected survival of less than 2 years.\n12. Patients with other acquired or congenital immunodeficiency diseases, or those currently using immunosuppressants.\n13. Patients who, upon screening inquiry, have alcohol dependence or a history of drug abuse.\n14. Pregnant or breastfeeding women; or those who plan to conceive, donate sperm, or donate oocytes during the trial and\u002For are unwilling to take effective contraception measures.\n15. Patients who participated in any other clinical trial within 1 month prior to screening.\n16. Patients who are allergic to any component of the investigational product.\n17. Patients deemed by the investigator to be unsuitable for participation in this trial.","75 Years",{"count":115,"type":21},54,[72,24],"This Phase I\u002FIIa, randomized, double-blind, placebo-controlled study evaluates the safety, tolerability, and preliminary efficacy of B2065, an allogeneic adipose-derived mesenchymal stromal cell (AD-MSC) injection, in patients with acute ischemic stroke. Participants receive a single intravenous infusion of B2065 or placebo within 36 hours of stroke symptom onset. Phase I uses dose escalation with sentinel dosing to assess dose-limiting toxicities within 28 days and to inform dose selection. Phase IIa expands 1-2 selected dose level(s) and randomizes participants 2:1 (B2065:placebo). Safety and functional outcomes are assessed through 24 months.",[119],"Acute Ischemic Stroke","2026-01-19",{"date":122,"type":33},"2026-01-28",{"date":124,"type":33},"2025-12-31",{"date":126,"type":21},"2027-12",{"name":39,"class":40},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":147,"locationsCount":148},"100569593","phase-3-a-study-of-lianxiaxiaopi-granules-in-the-treatment-of-postprandial-distress-syndrome-100569593","NCT06696261","A Study of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome","A Multicenter, Randomized, Double-blind, Placebo Parallel-controlled Phase III Clinical Trial on the Efficacy and Safety of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome (Intermingled Cold and Heat).","Inclusion Criteria:\n\n1. Age 18 to 65 years old (including boundary value), gender is not limited;\n2. meet the diagnostic criteria for postprandial distress syndrome (Rome IV.);\n3. Meet the syndrome differentiation standards of Traditional Chinese Medicine for cold and heat miscellaneous syndromes;\n4. NRS score of at least one symptom of postprandial distress syndrome (postprandial fullness, discomfort, early satiety) in the screening period and baseline period≥ 4 points; and did not have moderate\u002Fsevere epigastric pain syndrome (mid-epigastric burning sensation and mid-upper quadrant pain both \\\u003C 4 points);\n5. Those who did not have organic abnormal changes in the results of gastroscopy (including no abnormalities in gastroscopy, chronic non-atrophic gastritis\u002Fchronic superficial gastritis with erythema grade I and\u002For erosion that was flat and only grade I);\n6. Negative Helicobacter pylori test in 13C\u002F14C breath test during the screening period;\n7. Voluntarily participate in clinical trials, sign informed consent, and understand and comply with research procedures.\n\nExclusion Criteria:\n\n1. Those who have undergone Helicobacter pylori eradication treatment within 6 months before screening;\n2. Gastric mucosal erythema grade II or above, erosion is bulge or grade II or above, or accompanied by bleeding, bile reflux, ≥ 3 inflammatory polyps and other manifestations, or combined with pathological diagnosis of chronic atrophic gastritis, hyperplastic polyps, glandular polyps, etc.; or those who have been clearly diagnosed with dyspepsia caused by organic diseases of the digestive system, such as digestive tract tumors, hepatobiliary and pancreatic diseases, inflammatory bowel diseases, etc.; or those who have other diseases that affect the evaluation of dyspepsia-related symptoms in the past, such as reflux esophagitis, peptic ulcer, gastrointestinal bleeding, intestinal obstruction, etc.;\n3. Those who have been diagnosed with systemic diseases that seriously affect the function of the digestive tract, such as hyperthyroidism or hypothyroidism, diabetes, chronic renal insufficiency, connective tissue diseases, etc.;\n4. Patients with severe cardiovascular and cerebrovascular, liver, lung, kidney, blood or systemic diseases that affect their survival; or patients with severe mental illness in the past, such as moderate or severe depression\u002Fanxiety\u002Fbipolar disorder, etc.;\n5. Those who have a history of major abdominal surgery in the past, which may affect gastrointestinal function (except for appendectomy, cesarean section, endoscopic colon polyp resection and other surgeries that do not affect digestive function);\n6. Patients with abnormal liver function (ALT or AST \\>1.5 times the upper limit of normal) or abnormal renal function test (Cr\\> upper limit of normal);\n7. Glycosylated hemoglobin ≥ 6.5% or fasting blood glucose ≥7mmol\u002FL during the screening period;\n8. Use of drugs or treatments that may have an impact on the effectiveness assessment of the trial drug within 2 weeks before screening (such as acid\u002Fantacids, gastrointestinal motility drugs, digestive enzymes, gastric mucosal protectors, antiemetics, antispasmodics, macrolide antimicrobials, azole antifungals, non-steroidal anti-inflammatory drugs, glucocorticoids, anti-anxiety and depressants, analgesics, sedatives; as well as traditional Chinese medicine decoctions, proprietary Chinese medicines and acupuncture treatments for the treatment of functional dyspepsia, etc.);\n9. Pregnant and lactating women, who have a birth plan within one month after enrollment and the end of the trial;\n10. Those who suspect or have a history of alcohol or drug abuse;\n11. Participated in other clinical trials within 1 month before screening;\n12. Those who are suspected or known to be allergic to the ingredients of this medicine;\n13. According to the judgment of the investigator, it is not suitable to participate in this study.",{"count":136,"type":21},342,[25],"The goal of this clinical trial is evaluating the efficacy and safety of Lianxiaxiaopi Granules in participant population. The main questions it aims to answer are:\n\n1. Based on the Response rate of postprandial distress syndrome participants, evaluate whether the efficacy of Lianxiaxiaopi Granules is superior to placebo.\n2. Evaluate the efficacy of Lianxiaxiaopi Granules in improving symptom of postprandial distress syndrome.\n3. Evaluating the safety of Lianxiaxiaopi Granules in postprandial distress syndrome participants.",[140],"Postprandial Distress Syndrome","2026-01-15",{"date":143,"type":33},"2026-01-20",{"date":145,"type":33},"2025-02-27",{"date":37,"type":21},{"name":39,"class":40},18,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},"100613343","phase-1-a-phase-iii-clinical-trial-of-intramyocardial-injection-of-hucmscs-for-the-treatment-of-chronic-heart-failure-100613343","NCT07265349","A Phase I\u002FII Clinical Trial of Intramyocardial Injection of HucMSCs for the Treatment of Chronic Heart Failure","A Phase I\u002FII Clinical Trial to Evaluate the Safety and Efficacy of Intramyocardial Injection of Human Umbilical Cord Mesenchymal Stem Cells (HucMSCs) Combined With Coronary Artery Bypass Grafting in the Treatment of Chronic Heart Failure Caused by Chronic Ischemic Cardiomyopathy","Inclusion Criteria:\n\n* 1\\) Age from 18 to 80 years, both genders are eligible ;\n* 2\\) Clinically judged to be suitable for CABG treatment due to chronic ischemic cardiomyopathy;\n* 3\\) LVEF (left ventricular ejection fraction) is ≤ 40% as indicated by echocardiography (modified Simpson method) or cardiac magnetic resonance (CMR);\n* 4\\) NYHA (New York Heart Association) cardiac function classification of grade II-IV;\n* 5\\) Patients or their legal guardians agreed to participate in this trial and signed the informed consent form.\n\nMajor exclusion Criteria:\n\n* 1\\) Severe left ventricular dysfunction, with LVEF ≤ 20% (based on the UCG or CMR examination results during the screening period);\n* 2\\) Non-ischemic chronic left heart dysfunction, including but not limited to acute left heart dysfunction, dilated cardiomyopathy, severe right heart dysfunction (such as bilateral lower extremity edema accompanied by jugular vein distension, liver enlargement, etc.) or severe pulmonary hypertension (PASP \\> 70 mmHg);\n* 3\\) Clinically determined that other surgical procedures need to be performed simultaneously during CABG surgery, including but not limited to congenital heart disease requiring concurrent surgical intervention, heart valve disease, ventricular aneurysm, ventricular septal perforation, papillary muscle dysfunction, aortic dissection, intracardiac mass, thrombus or neoplasm；\n* 4\\) Acute ST-segment elevation myocardial infarction or stroke event within 1 month before enrollment；\n* 5\\) Uncontrolled malignant arrhythmia;\n* 6)have undergone or are awaiting heart transplantation or implantation of a left ventricular assist device (LVAD).","80 Years",{"count":158,"type":21},51,[72,24],"B2278 is a human umbilical cord mesenchymal stem cell (HucMSCs) injection derived from the umbilical cord. It has the advantages of stronger immune regulation, stronger expansion capacity, lower immunogenicity, and greater accessibility. The preliminary research results indicated that the B2278 injection promote the polarization of macrophages towards a reparative state through paracrine action, directly promote angiogenesis and inhibited inflammatory responses, thereby exerting effects on myocardial repair and treatment of heart failure, and it is also safe and well-tolerated.\n\nThis trial is a multi-center I\u002FII phase clinical trial of the human umbilical cord mesenchymal stem cell injection solution, aiming to explore the dosage and regimen for the intramyocardial injection of B2278 in combination with coronary artery bypass grafting surgery for the treatment of chronic heart failure caused by chronic ischemic cardiomyopathy, and to evaluate the safety, tolerance and efficacy of allogeneic intramyocardial injection of the human umbilical cord mesenchymal stem cell injection solution in patients with chronic ischemic heart failure.",[162,163,164],"Coronary Artery Bypass Grafting (CABG)","Chronic Heart Failure","Chronic Ischemic Cardiomyopathy","2026-01-07",{"date":167,"type":33},"2026-01-09",{"date":169,"type":33},"2025-12-26",{"date":171,"type":21},"2027-08-01",{"name":39,"class":40},4,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":181,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},"100575502","phase-3-phase-iii-trial-of-susu-zhike-granules-in-children-with-cold-cough-syndrome-for-acute-cough-treatment-100575502","NCT06773117","Phase III Trial of Susu Zhike Granules in Children With Cold-cough Syndrome for Acute Cough Treatment","Efficacy\u002FSafety of Susu Xiao'er Zhike Granules for Children's Cold-Induced Cough (Wind-Cold Syndrome): Multicenter, Randomized, Double-Blind, Low-Dose Controlled Phase III Trial","Inclusion Criteria:\n\n1. It met the diagnostic criteria for common cold, and the severity VAS score of day or night cough was ≥40 mm ，the cough symptom score was ≥2 points;\n2. Conforming to the standard of wind-cold cough differentiation;\n3. Age 6-13 years old (6 years old ≤ age \\\u003C 14 years old);\n4. Duration of cough ≤48 hours;\n5. Maximum axillary temperature ≤38℃ within 24 hours before diagnosis;\n6. The informed consent process should be in accordance with the regulations, and the legal guardian or the subject child (≥8 years old) should sign the informed consent.\n\nExclusion Criteria:\n\n1. accompanied by pharyngeal swelling pain, heat image is obvious;\n2. White blood cell count, neutrophils absolute value, C-reactive protein, all exceeded the upper limit of 1.2 times the reference value, and the researchers considered the bacterial infection;\n3. there have been complications (bacterial otitis media, sinusitis, suppurative tonsillitis, bronchitis, bronchopneumonia);\n4. Patients with acute bronchitis and pneumonia cured less than 8 weeks;\n5. People with a history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory infections;\n6. Other acute episodes of nasal diseases (vasomotor rhinitis, drug rhinitis, etc.), nasal foreign body, or foreign body inhalation, any anatomical respiratory abnormalities;\n7. Patients with serious systemic diseases or mental disorders such as cardiovascular, brain, liver, kidney and hematopoietic system;\n8. Those who had used Chinese and Western drugs and therapies that had influence on the effectiveness evaluation of the experimental drugs within 24 h before enrollment;\n9. Allergic to known components of the investigational drug;\n10. Those who participated in other clinical trials and took investigational drugs within the past one month;\n11. Those who were not considered suitable for inclusion by the researchers.","6 Years","13 Years",{"count":184,"type":21},360,[25],"To confirm the effect of Susu Xiaoer Zhike granules in treating cough caused by common cold (wind-cold cough Syndromes) in children aged 6\\~13 years, shortening the course of disease and improving symptoms.",[188],"Cough","2025-08-14",{"date":191,"type":33},"2025-08-19",{"date":193,"type":21},"2025-09-01",{"date":195,"type":21},"2027-12-31",{"name":39,"class":40},19,{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":219},"100574023","phase-3-efficacy-and-safety-of-changkang-granules-in-the-treatment-of-irritable-bowel-syndrome-with-predominant-diarrhea-liver-qi-affecting-the-spleen-pattern-100574023","NCT06753890","Efficacy and Safety of Changkang Granules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver qi Affecting the Spleen Pattern)","A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial, Efficacy and Safety Study of Changkang Granules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea ( Liver qi Affecting the Spleen Pattern)","Inclusion Criteria:\n\n* Participants must meet all of the following inclusion criteria to be eligible for this trial:\n\n  1. Age 18-65 years (inclusive), regardless of gender;\n  2. Meet the Western medical diagnostic criteria for Irritable Bowel Syndrome with Predominant Diarrhea (Rome IV);\n  3. Meet the Traditional Chinese Medicine diagnostic criteria for Liver qi affecting the spleen pattern\n  4. Have a weekly average NRS score for abdominal pain ≥3.0 during the Run-In Period period, and have at least 2 days per week with stool form of type 6 or 7 (Bristol Stool Scale) during the Run-in period;\n  5. Have an IBS-SSS score \\>175 at baseline;\n  6. Have completed a colonoscopy within the past 12 months prior to the Run-in period, and meet one of the following conditions: ① Normal colonoscopy results with no organic changes; ② Abnormal colonoscopy report, such as hemorrhoids, polyps (diameter ≤5mm and number ≤3), etc., which the investigator determines can be included; ③ Previous colonoscopy report indicating polyps \\>5mm in diameter or \\>3 in number, which after endoscopic treatment 6 months ago, residual polyps are ≤5mm in diameter and ≤3 in number, and the investigator determines can be included;\n  7. Voluntarily sign the informed consent form, and from the time of signing the informed consent form until the end of the last visit of the trial, the participant voluntarily accepts health education and maintains their usual diet and lifestyle, such as not changing dietary structure or exercise patterns.\n\nExclusion Criteria:\n\n* Subjects with any of the following conditions are not eligible for enrollment in this study:\n\n  1. Subjects who have less than 3 spontaneous bowel movements per week during the run-in period; or at least 2 days per week during the run-in period with stool consistency classified as type 1 or 2 on the Bristol Stool Scale;\n  2. Patients with a history of severe mental or psychological disorders, or those scoring ≥63 on the Self-Rating Depression Scale (SDS), or ≥60 on the Self-Rating Anxiety Scale (SAS) during the screening period;\n  3. Patients with a confirmed history of organic gastrointestinal diseases, including both gastrointestinal and non-gastrointestinal digestive system diseases, such as chronic superficial gastritis with erosions or bleeding of grade II or higher, chronic atrophic gastritis, peptic ulcers, inflammatory bowel disease, intestinal tuberculosis, intestinal ulcers, intestinal obstruction, intestinal adhesions, eosinophilic gastroenteritis, cholelithiasis with recurrent cholecystitis (patients with gallstones or gallbladder polyps ≤0.5 cm in diameter and no significant symptoms may be exempted from exclusion upon investigator's judgment), tuberculous peritonitis, liver cirrhosis, and digestive system tumors, etc.;\n  4. Patients diagnosed with other diseases that affect the evaluation of abdominal pain and diarrhea, such as diarrhea caused by lactose intolerance, diarrhea after cholecystectomy, abdominal pain due to endometriosis, abdominal pain caused by hepatic and biliary stones or cholecystitis, abdominal pain due to chronic pancreatitis, etc.;\n  5. Patients with a history of systemic diseases affecting gastrointestinal function, such as diabetes mellitus, hyperthyroidism or hypothyroidism, chronic renal insufficiency, autoimmune diseases (such as allergic colitis, allergic purpura, Behcet's syndrome, systemic lupus erythematosus), etc.;\n  6. Patients with a history of major abdominal surgery involving the gastrointestinal tract, liver, gallbladder, spleen, or pancreas (subjects who have undergone appendectomy or cesarean section without impact on gut function may be exempted from exclusion upon investigator's judgment);\n  7. Patients with unexplained recurrent positive fecal occult blood, unintentional weight loss, anemia, fever, or jaundice prior to screening;\n  8. Abnormal liver function at baseline (ALT or AST \\>1.5 times the upper limit of normal) or abnormal renal function at baseline (Cr \\>upper limit of normal);\n  9. Patients with a history of severe diseases in the respiratory, cardiovascular, cerebral, hepatic, renal, endocrine, immune, hematopoietic systems, as well as tumors and neurological diseases, deemed unsuitable for participation in this trial by the investigator;\n  10. Patients who have used prokinetic agents, anticholinergic drugs, calcium channel blockers (excluding antihypertensive drugs), 5-HT3 receptor antagonists, antidiarrheals, antidepressants, anxiolytics, probiotics, analgesics, laxatives, etc., within 4 weeks before randomization;\n  11. Patients who took rescue medication (piroxicam) during the run-in period;\n  12. Pregnant or breastfeeding women, or those planning to conceive within 1 month after enrollment until the end of the trial;\n  13. Patients suspected or known to be allergic to the investigational drug, rescue medication, or its components;\n  14. Patients suspected or known to have a history of alcohol or drug abuse;\n  15. Patients who participated in another interventional clinical trial and took investigational drugs within 1 month before screening;\n  16. Patients whom the investigator deems unsuitable for clinical trial participation for any other reason.",{"count":206,"type":21},520,[25],"This study will evaluate the efficacy and safety of Changkang granules in the treatment of irritable bowel syndrome with predominant Diarrhea ( Liver qi affecting the spleen pattern)",[210],"Diarrhea-predominant Irritable Boewl Syndrome","2024-12-22",{"date":213,"type":33},"2024-12-31",{"date":215,"type":21},"2024-12-30",{"date":217,"type":21},"2026-12-30",{"name":39,"class":40},30,{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":241},"100569718","phase-3-a-study-of-the-efficacy-and-safety-of-antiwei-granules-in-the-treatment-of-common-cold-100569718","NCT06697886","A Study of the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold","To Evaluate the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold (Wind-cold Syndrome) in a Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Trial","Inclusion Criteria:\n\n1. It met the diagnostic criteria of common cold in western medicine;\n2. In accordance with the TCM syndrome differentiation standard of wind-cold syndrome;\n3. Male and female patients aged 18 to 65 years;\n4. The disease duration at enrollment was ≤48 h;\n5. At enrollment, 37.3 ° C ≤axillary temperature \\\u003C 38.5 ° C;\n6. Informed consent was obtained voluntarily.\n\nExclusion Criteria:\n\n1. Complicated with influenza, pneumonia, suppurative tonsillitis, acute tracheobronchitis, acute pharyngeal conjunctivitis, acute viral or herpetic pharyngitis, acute viral or herpetic laryngitis;\n2. Patients who had been infected with 2019-ncov in the past and still had symptoms such as cough and fatigue for nearly 3 months after the antigen turned negative;\n3. Primary ciliary dyskinesia syndrome, other acute onset nasal diseases (such as allergic rhinitis, chronic rhinitis, acute and chronic sinusitis, etc.), previous nasal surgery or radiotherapy of the nasopharynx with nasal mucosal dysfunction；\n4. Patients with chronic respiratory diseases (such as chronic obstructive pulmonary disease, interstitial lung disease, etc.), asthma, and tuberculosis;\n5. White blood cell count \\>12.0×10\\^9\u002FL or \\\u003C3.0×10\\^9\u002FL , And\u002For neutrophil percentage \\>80%;\n6. Aspartate aminotransferase and\u002For alanine aminotransferase ≥ 1.5 × ULN, or serum creatinine ≥ ULN, judged by the investigator to be clinically significant；\n7. Combined with other serious primary diseases of the heart, brain, lung, liver, kidney or blood system, such as unstable control\u002Fserious complications of diabetes, viral hepatitis, hemophilia, or mental disorders;\n8. Patients who had been treated with Chinese and western drugs for the relief of common cold and its symptoms after the onset of the current illness, including but not limited to antibiotics, antiviral, antihistamine, steroids, decongestants, antipyretic and analgesic, antitussive and expectorant drugs etc;\n9. Those who were allergic to the known composition of the investigational drug or to emergency medication, or emergency drug contraindication population;\n10. The participants (and their partners) had planned pregnancy or were unwilling to take appropriate contraceptive measures from enrollment to 1 month after the end of the trial, or were pregnant or lactating;\n11. Suspected or true history of alcohol or drug abuse;\n12. Participants who had participated in another clinical trial within 1 month before enrollment;\n13. Persons deemed unsuitable for clinical trial by the investigator (e.g., athletes or persons not eligible for enrollment for other reasons).",{"count":228,"type":21},480,[25],"To further evaluate the efficacy and safety of Antiwei granule in the treatment of common cold (wind-cold syndrome)",[232],"Common Cold","2024-11-18",{"date":235,"type":33},"2024-11-20",{"date":237,"type":33},"2023-11-16",{"date":239,"type":21},"2025-07-01",{"name":39,"class":40},24,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":249,"targetDuration":4,"studyType":22,"phases":251,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":260,"locationsCount":261},"100516164","phase-3-a-study-of-comparing-overall-improvement-of-patients-with-spondyloarthritis-treated-with-jitongning-tablets-and-placebo-100516164","NCT06000956","A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Protocol of the Efficacy and Safety of Jitongning Tablets for Treating Spondyloarthritis (Kidney Yang Deficiency and Blood Stasis Obstruction)","Inclusion Criteria:\n\nAll of the following standards must be met:\n\n1. Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender;\n2. Meets the diagnostic criteria for axial osteoarthritis recommended by ASAS in 2009, and the condition is in an active phase. The criteria for determining disease activity are to meet two criteria: Bass ankylosing spondylitis disease activity index (BASDAI) ≥ 40mm (0-100mm, evaluated using VAS); Spinal pain score ≥ 40mm (0-100mm, evaluated using VAS);\n3. Conforming to the traditional Chinese medicine syndrome differentiation standards for kidney yang deficiency and blood stasis obstruction syndrome;\n4. CT examination of sacroiliac arthritis grades I (A) to II (B) (both included);\n5. Human leukocyte antigen B27 (HLA-B27) is positive;\n6. Elevated C-reactive protein (CRP)\u002Fhypersensitive C-reactive protein (hsCRP) and\u002For erythrocyte sedimentation rate (ESR);\n7. Voluntarily participate in this clinical trial and sign an informed consent form.\n\nExclusion Criteria:\n\nThose who meet any of the following criteria cannot be included in this experiment:\n\n1. Received non-steroidal anti-inflammatory drugs within 2 weeks before enrollment;\n2. Within 4 weeks before enrollment, he received traditional Chinese patent medicines and simple preparations or traditional Chinese medicine decoction, chemical drugs (such as sulfasalazine, methotrexate, leflunomide, hydroxychloroquine, cyclophosphamide, azathioprine, etc.), opioid analgesics (such as methadone, morphine, etc.), JAK inhibitor drugs (such as tofatib, etc.), and systemic glucocorticoid treatment;\n3. Received spinal or joint surgery treatment within 8 weeks prior to enrollment;\n4. Within 12 weeks prior to enrollment, biological agents with therapeutic effects on spinal arthritis have been used;\n5. Within 6 months prior to enrollment, corticosteroid injections were received into the joint cavity or spine\u002Fparavertebral area;\n6. CT indicates disappearance of sacroiliac joint space or complete spinal rigidity;\n7. Subjects diagnosed with other rheumatic immune system diseases or immune deficiency syndrome, such as active ulcerative colitis, psoriasis, uveitis, etc;\n8. Those who have fertility requirements within six months;\n9. Pregnant or lactating women;\n10. Suspected or actual drug, substance, or alcohol abuse;\n11. Within 3 months prior to the trial or currently participating in clinical trials;\n12. Serious heart, liver, kidney, brain, mental, and neurological disorders that affect informed consent and\u002For expression or observation of adverse events;\n13. Abnormal liver function (elevated levels of alanine or alanine aminotransferase above the upper limit of normal values); Abnormal renal function (serum creatinine levels above the upper limit of normal values);\n14. The researchers believe that it is not suitable to participate in this experiment.",{"count":250,"type":21},408,[25],"The goal of this clinical trial is evaluating the efficacy and safety of Jitongning tablets in participant population. The main questions it aims to answer are:\n\n* Based on the proportion of participants who achieved improvement in ASAS20, evaluate whether the efficacy of Jitongning tablets is superior to placebo in active ax-SpA adult participants.\n* Evaluate the efficacy of Jitongning tablets in improving other key functions and symptom outcomes.\n* Evaluating the safety of Jitongning tablets in adult ax-SpA participants. Participants will\n\n  1. take orally Jitongning tablets or a simulated agent of Jitongning tablets.\n  2. Receive examinations and follow-up visits.",[254],"Ankylosing Spondylitis",{"date":256,"type":33},"2024-11-21",{"date":258,"type":33},"2023-09-11",{"date":37,"type":21},{"name":39,"class":40},10,{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":269,"sex":270,"minAge":17,"maxAge":49,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},"100568803","phase-3-efficacy-and-safety-of-xiangjurupining-capsule-for-hyperplasia-of-mammary-glands-100568803","NCT06685978","Efficacy and Safety of Xiangjurupining Capsule for Hyperplasia of Mammary Glands","A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Clinical Trial of Efficacy and Safety of Xiangjurupining Capsule in the Treatment of Hyperplasia of Mammary Glands(Syndrome of Stagnation of Liver-qi and Phlegm)","Inclusion Criteria:\n\n1. Female patients aged 18 to 50 (including boundary values);\n2. Those who meet the diagnostic criteria for breast hyperplasia in Western medicine and have a disease course of more than 3 months;\n3. Meets the traditional Chinese medicine differentiation criteria for liver depression and phlegm coagulation syndrome;\n4. The BI-RADS grading of the target side breast ultrasound is 2-3 levels, while the BI-RADS grading of the non target side breast ultrasound is 1-3 levels;\n5. During the screening period, the NRS score is ≥ 4 and there is a target mass detected by palpation;\n6. During the introduction period, the average NRS score within the day of pain involvement is ≥ 4 points, and there is still the presence of the target mass on palpation;\n7. During the import period, the number of days with pain involvement in the menstrual cycle is greater than 7 days;\n8. With informed consent, voluntarily participate in the experiment and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Those who suffer from other breast diseases or breast pain caused by other reasons, such as mastitis, breast cancer, etc;\n2. Patients with severe cardiovascular, cerebrovascular, liver, kidney, malignant tumors, hematological diseases, and psychiatric disorders;\n3. Patients who have been previously diagnosed with dysfunctional uterine bleeding, amenorrhea, polycystic ovary syndrome, menopausal syndrome, hyperprolactinemia, Cushing's syndrome, and other diseases and still require treatment by adjusting hormone levels; Individuals who have been diagnosed with diseases that require long-term use of painkillers, such as dysmenorrhea, and are expected to be unable to stop using painkillers during the trial period.\n4. Abnormal liver function (ALT or AST or ALP or GGT\\>1.2 times the upper limit of normal values) or abnormal kidney function (serum Cr or BUN or Urea\\>1.2 times the upper limit of normal values) that the researcher considers clinically significant and is not suitable for participation in clinical trials;\n5. Women who are in pregnancy, lactation, menopause, or have a pregnancy plan within the past 6 months;\n6. Chinese and western medicines and other therapies (including external application medicine, acupuncture and moxibustion, etc.) used to treat breast hyperplasia or relieve breast pain within 1 month or 5 half lives (whichever is the shortest) before screening and during the induction period, or contraceptives and sex hormone drugs have been used within half a year;\n7. Individuals with severe menstrual cycle and\u002For menstrual irregularities (menstrual cycle\\>35 days or\\\u003C21 days and\u002For menstrual period\\\u003C3 days or\\>7 days);\n8. Individuals with allergic constitution and known allergies to the components of the experimental drug prescription;\n9. Suspect or have a history of alcohol and drug abuse;\n10. Select patients who have participated in clinical trials and used investigational drugs within the previous month;\n11. Failure to follow the physical contraceptive measures recognized by researchers for contraception;\n12. According to the researchers' assessment, there may be other conditions or conditions that reduce the likelihood of inclusion or complicate the trial, such as frequent changes in the work environment that can lead to loss to follow-up, and individuals who cannot provide sufficient informed consent due to mental and behavioral disorders.",true,"FEMALE",{"count":272,"type":21},430,[25],"This study will evaluate the efficacy and Safety of Xiangjurupining Capsule in the treatment of Hyperplasia of Mammary Glands(stagnation of liver-qi and phlegm).",[276],"Hyperplasia of Mammary Glands","2024-11-10",{"date":279,"type":33},"2024-11-13",{"date":281,"type":33},"2024-04-26",{"date":283,"type":21},"2026-07-31",{"name":39,"class":40},27,{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":16,"minAge":293,"maxAge":294,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":307,"locationsCount":41},"100567513","phase-2-efficacy-and-safety-of-jia-shen-tablets-in-chronic-heart-failure-100567513","NCT06669169","Efficacy and Safety of Jia Shen Tablets in Chronic Heart Failure","A Randomized, Placebo-Controlled, Double-Blind and Multi-Centre Phase II Clinical Trial：Efficacy and Safety of Jia Shen Tablets in the Treatment of Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Yang Qi Deficiency With Blood Stasis)","Inclusion Criteria:\n\n* Age 40-79 years, either sex;\n* Meet the diagnostic criteria for CHD and CHF;\n* Meet the TCM differentiation criteria of yang qi deficiency and blood stasis in CHF;\n* Class Ⅱ to Ⅲ for NYHA functional classification;\n* Willing to provide written informed consent.\n\nExclusion Criteria:\n\n* CHF with acute exacerbation or intravenous drug therapy;\n* Received cardiac resynchronization therapy (CRT) or other heart failure devices;\n* Within 3 months before randomization, acute coronary syndrome（ACS）, stroke or transient ischemic attack（TIA） occurred or received cardiac revascularization (PCI, CABG);\n* Plan to undergo cardiac revascularization (PCI, CABG) or cardiac resynchronization therapy (CRT) during the trial period;\n* Severe arrhythmias \\[such as persistent atrial fibrillation, permanent atrial fibrillation, ventricular tachycardia, second-degree type II or higher sinus or atrioventricular block without pacemaker placement, QT interval (QTc) exceeding 480 ms after heart rate adjustment according to Fridericia's formula, or known history or symptoms of long QT syndrome\\];\n* Severe hypertension (systolic blood pressure ≥180mm Hg or diastolic blood pressure ≥110mm Hg) or hypotension (systolic blood pressure \\\u003C 90 mmHg);\n* Heart failure caused by other cardiovascular diseases such as congenital heart disease, severe stenosis or insufficiency of heart valves, cardiomyopathy (e.g. hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy), moderate pericardial effusion, constrictive pericarditis, and infective endocarditis;\n* Combined with liver, kidney, hematopoietic system and other serious primary diseases, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3 times the upper limit of local laboratory normal value, the estimated glomerular filtration rate (eGFR) \\\u003C 30 ml\u002Fmin\u002F1.73m2, Blood potassium \\> 5.5 mmol\u002FL or hemoglobin (Hb) \\\u003C 90 g\u002FL; Malignant tumors, severe neuroendocrine system diseases and mental diseases;\n* Pregnant or lactating;\n* Participating in other interventional clinical studies within 1 month before screening;\n* Allergic constitution, or allergic to Chinese medicines of Jia Shen Tablets (such as Periploca sepium, salvia miltiorrhiza, etc.);\n* The investigator determines that the patient is unable to complete the study or comply with the requirements of the study.","40 Years","79 Years",{"count":296,"type":21},288,[24],"Evaluate the efficacy and safety of Jia Shen Tablets in patients with Chronic Heart Failure.",[300],"Heart Failure","2024-10-31",{"date":303,"type":33},"2024-11-01",{"date":305,"type":21},"2025-01-31",{"date":37,"type":21},{"name":39,"class":40},{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":315,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":328},"100520590","phase-2-efficacy-and-safety-of-jiuweihuaban-pill-for-treating-plaque-psoriasis-100520590","NCT06058546","Efficacy and Safety of Jiuweihuaban Pill for Treating Plaque Psoriasis","A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Clinical Trial of Efficacy and Safety of Jiuweihuaban Pill in the Treatment of Moderate to Severe Plaque Psoriasis(Syndrome of Blood-heat ).","Inclusion Criteria:\n\n1. Aged 18-65, male or female.\n2. The diagnosis of plaque psoriasis vulgaris was in accordance with the western diagnostic criteria\n3. Conformed to the TCM syndrome differentiation standard of plaque psoriasis with Blood-heat syndrome.\n4. At screening period: 3 ≤PASI≤ 20, 3%≤BSA≤ 10% and sPGA≥2.\n5. Willing to participate voluntarily and sign a written informed consent.\n\nExclusion Criteria:\n\n1. Psoriasis caused by drug-induced factors; combined with non-plaque Psoriasis at screening (such as guttate,arthropathica, pustular, erythrodermic and other types of Psoriasis); The skin lesions are exclusively observed in subjects with specific areas such as the face, scalp, nails, skin folds, glans penis, mucous membranes, palms, and soles.\n2. Systemic therapy with non-biological drugs within 4 weeks prior to randomization, including but not limited to systemic corticosteroids, retinoids, methotrexate, and cyclosporine.\n3. Systemic therapy with biological drugs within 12 weeks or 5 half-lives (whichever is longer) prior to randomization, including but not limited to interleukin antibodies (such as ustekinumab, secukinumab) and tumor necrosis factor-alpha antagonists (such as etanercept, infliximab, adalimumab) in the study.\n4. Topical anti-psoriatic treatment received within 2 weeks prior to randomization, including retinoids, vitamin D3 derivatives, corticosteroids, and others\n5. Physical therapy received within the 4 weeks prior to randomization, including phototherapy (such as UVB, PUVA), combination phototherapy, and balneotherapy.\n6. Systemic anti-infective treatment received within the 4 weeks prior to randomization; presence of recurrent, chronic, or active infection at baseline as determined by the investigator and judged to increase the subject's risk.\n7. With a serious, progressive, or uncontrolled disease, including but not limited to a disease of the immune (such as rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease), endocrine, hematological, urinary, hepatobiliary, and respiratory, nervous, psychiatric, cardiovascular, gastrointestinal, or infectious system, a malignancy.\n8. Patients with serum creatinine above the upper limit of normal at screening, with elevated Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) levels ≥ 1.5 times the upper limit of normal.\n9. Participation in other clinical trials and received investigational drugs within 1 month prior to screening.\n10. Patients with hypersensitivity to the investigational drug components.\n11. Patients had a history of smoking, alcohol, drug abuse.\n12. Patients (including partners) have plans to become pregnant from 2 weeks before the first dose to 1 month after the last dose and Subjects do not take effective contraceptive measures during this period or during pregnancy or breastfeeding\n13. Any other situation that the investigator did not consider suitable for participation in the study, such as other skin problems that hinder the assessment of Psoriasis, potential compliance problems, inability to complete all examinations and evaluations in accordance with the protocol requirements, may pose an uncontrollable risk for participation in the study.",{"count":20,"type":21},[24],"This study will evaluate the efficacy and safety of Jiuweihuaban Pill in the treatment of moderate to severe plaque psoriasis(syndrome of blood-heat ).",[319],"Plaque Psoriasis","2024-08-29",{"date":322,"type":33},"2024-09-03",{"date":324,"type":33},"2023-11-23",{"date":326,"type":21},"2025-10",{"name":39,"class":40},12,{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":336,"targetDuration":4,"studyType":22,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":347,"locationsCount":348},"100487881","phase-2-huhuanglianzonggan-capsule-in-subjects-with-nonalcoholic-steatohepatitis-a-phase-2-trialhhl-hepar-100487881","NCT05632861","HuHuangLianzonggan Capsule in Subjects With Nonalcoholic Steatohepatitis: a Phase 2 tRial(HHL-HEPAR)","Efficacy and Safety of HuHuangLianzonggan Capsule in Subjects With Nonalcoholic steatoHEPAtitis: a Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 2 tRial(HHL-HEPAR)","Inclusion Criteria:\n\n1. Males and females between 18-75 years of age inclusive(including boundary values).\n2. Must have had a liver biopsy proven NASH within 6 months or in screening test. The following two requirements must be met at the same time: ① a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components: Steatosis≥1, Lobular inflammation≥1, Ballooning degeneration≥1;② fibrosis stage 1 to 3.\n3. Must have confirmation of ≥ 8% liver fat content on magnetic resonance imaging- proton density fat fraction (MRI-PDFF) at screening.\n4. No alcohol consumption or history of excessive alcohol consumption: less than 210 g of ethanol per week for men and 140 g for women in the past 12 months.\n5. Patients who are taking chronic drugs(including but not limited to antihypertensive drugs, antiatherogenic drugs, oral hypoglycemic drugs, insulin) need to have a steady dose for at least 3 months before liver biopsy.\n6. Weight was stable(the change is no more than 5%) during the 6 months prior to Screening.\n7. No attempt to change lifestyle (diet and\u002For exercise) during the 3 months prior to Screening.\n8. Ability to understand the requirements of the study and willingness to provide written informed consent.\n9. Have no pregnancy program and take effective contraceptive measures voluntarily.\n10. Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment.\n\nExclusion Criteria:\n\n1. Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) administered for at least 2 weeks within 12 months prior to qualifying liver biopsy (e.g. valproic acid, tamoxifen, methotrexate, amiodarone, oral corticosteroids, \\>5 mg\u002Fday of prednisone equivalent \\[one short (\\\u003C2 weeks) course of oral corticosteroids, more than 3 months before the liver biopsy is allowed\\], or oestrogens \\[at doses greater than those used for contraception or hormone replacement\\]).\n2. Documented causes of fatty liver disease other than NASH including, but not restricted to: HCV-associated fatty liver (genotype 3), hepatolenticular degeneration, autoimmune hepatitis, total parenteral nutrition, abetalipoproteinemia, lipoatrophy , Coeliac disease, Primary sclerosing cholangitis, Alpha-1-antitrypsin deficiency, Drug-induced liver disease.\n3. Model for End-stage Liver Disease (MELD) score \\>12.\n4. Histologically documented liver cirrhosis (fibrosis stage F4), history or current diagnosis of hepatocellular carcinoma HCC.\n5. History of or planned liver transplant.\n6. Viral hepatitis：Positive hepatitis A antibody，Positive hepatitis D antibody，Positive hepatitis E antibody，Positive hepatitis B surface antigen (HBsAg) ，Positive hepatitis C antibody.\n7. Abnormal liver function as defined by Screening central laboratory evaluation of any of the following: ALT or AST \\>5 × ULN; Alkaline phosphatase (ALP) \\>2 × ULN; albumin below the lower limit of the normal range; total bilirubin level \\>1.5 × ULN (patients with a documented history of Gilbert's syndrome can be enrolled if the direct bilirubin is within normal reference range).\n8. In patients who are not anticoagulated, INR ≥ 1.3 times ULN or other evidence of impaired coagulation.\n9. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value \\\u003C30 mL\u002Fmin\u002F1.73 m2.\n10. Patient currently receiving any approved treatment for NASH.\n11. HbA1c ≥9% or fasting blood-glucose\\>13.9 mmol\u002FL at Screening.\n12. Diabetes mellitus other than type 2 (e.g. type 1, diabetes caused by drugs or chemicals, and immune-mediated diabetes).\n13. Those who are underweight, of normal weight, or severely obese, i.e BMI\\\u003C23 kg\u002Fm2 or BMI≥40 kg\u002Fm2.\n14. Bariatric surgery or tumor surgery are not allowed within 5 years of the qualifying liver biopsy.\n15. Uncontrolled hypertension (values ≥160\u002F100 mm Hg) or hypotension（values \\\u003C80\u002F50 mmHg）.\n16. Acute vascular events including ACS, stroke, peripheral vascular disease worsened, or any vascular\u002Fcardiac surgery within the 6 months prior to Screening.\n17. Concomitant mental illness and poor condition control, which affects the signing of informed consent or presentation of adverse events.\n18. Do not have a liver biopsy within the 6 months prior to Screening and refuse to take liver biopsy at Screening.\n19. Allergic constitution, or allergic to the test drug or its ingredients.\n20. Women who are pregnant or lactating.\n21. Participate in clinical trials of other drugs within 3 months before screening.\n22. The researchers did not consider it appropriate to participate in this study.",{"count":337,"type":21},76,[24],"This study will evaluate the efficacy and safety and the best effective dose of HuHuangLianzonggan capsule in subjects with nonalcoholic steatohepatitis.",[341],"NASH","2024-08-28",{"date":320,"type":33},{"date":345,"type":33},"2023-02-21",{"date":213,"type":21},{"name":39,"class":40},20,{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":357,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":41},"100542871","phase-1-pharmacokinetic-and-pharmacodynamic-of-jia-shen-tablets-in-chronic-heart-failure-100542871","NCT06348498","Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure","A Open Label, Standardise-loaded and Single-Centre Phase Ⅰb Clinical Trial：Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure","Inclusion Criteria:\n\n* Age 18-75 years, either sex;\n* Meet the diagnostic criteria for CHD and CHF;\n* Meet the TCM differentiation criteria of yang deficiency and blood stasis in CHF;\n* LVEF \\\u003C 40% (Modified Simpson's Method);\n* Class II to IⅢ for NYHA functional classification;\n* Receive Steady dose of standard medication for CHF for at least 2 weeks;\n* Understand the research requirements and are willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Acute heart failure or acute exacerbation of chronic heart failure;\n* HF caused by other heart diseases, such as congenital heart disease, severe stenosis or insufficiency of heart valves, cardiomyopathy (e.g., hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy), moderate massive pericardial effusion, constrictive pericarditis, infective endocarditis;\n* Patients with acute coronary syndrome within 30 days before receiving the trial drug，and the following situation within 6 months before receiving the trial drug，such as acute myocardial infarction，revascularization (e.g., PCI, CABG) or left ventricular reconstruction surgery, pacemaker implantation for cardiac resynchronization, and undergoing cardiothoracic surgery;\n* Expect to receive an implantable device (e.g. ICD, CRT), or revascularization (e.g. PCI, CABG), or other cardiovascular surgery during the trial period;\n* Severe arrhythmias \\[e.g., ventricular tachycardia, second degree type II or higher sinus or atrioventricular block without pacemaker placement, QT interval (QTc) greater than 480 ms after heart rate adjustment according to Fridericia's formula, or known history or symptoms of long QT syndrome\\];\n* Combined with serious diseases of other systems, such as liver, kidney, hematopoietic system and other serious primary diseases, tumors, mental diseases, etc;\n* The presence of uncontrolled hypertension (systolic blood pressure ≥180 mmHg and\u002For diastolic blood pressure ≥110 mmHg), or the presence of hypotension (systolic blood pressure \\\u003C 80 mmHg and\u002For diastolic blood pressure \\\u003C 50 mmHg);\n* ALT or AST more than 3 times the upper limit of normal, and\u002For estimated glomerular filtration rate (eGFR) \\\u003C 30 ml\u002Fmin\u002F1.73m2;\n* Glycosylated hemoglobin (HbA1c) ≥9.0%, or fasting blood glucose ≥13.9 mmol\u002FL;\n* Anemia (Hb \\\u003C 110 g\u002FL for women, Hb \\\u003C 120 g\u002FL for men);\n* Blood potassium is above the upper limit of normal;\n* Patients who tested positive for five hepatitis B tests (except surface antibodies) or hepatitis C, or anti-TP or HIV antibodies;\n* Patients with a history of drug abuse who test positive for drug abuse (morphine, methamphetamine, ketamine, dimethyldioxyamphetamine, THC, cocaine);\n* Women who are pregnant or nursing, or have a need to have children within 3 months after the last dose of the trial;\n* Participating in other studies and taking investigational drugs from other studies within 3 months prior to screening;\n* Allergic to Jiashen tablets or their ingredients;\n* Other situations judged by the researchers to be inappropriate for this study.",{"count":148,"type":21},[72],"Evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in patients with Chronic Heart Failure.",[300],"2024-06-26",{"date":362,"type":33},"2024-06-28",{"date":364,"type":33},"2024-04-09",{"date":366,"type":21},"2026-06-30",{"name":39,"class":40},""]