[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tcm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tcm":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,61,89],{"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":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100602898","shenbai-granules-for-preventing-malignant-transformation-of-high-risk-colorectal-adenomas-100602898",false,"NCT07129499","Shenbai Granules for Preventing Malignant Transformation of High-risk Colorectal Adenomas","A Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Trial of Shenbai Granules for Preventing Malignant Transformation of High-Risk Colorectal Adenomas","Inclusion Criteria:\n\nAll of the following criteria must be met for enrolment:\n\n1. Aged 40-75 years, regardless of gender;\n2. High-quality colonoscopy performed within 14 days before randomisation, with initial endoscopic resection of all polyps and histological confirmation of at least one HR-CRA criteria;\n3. Complete endoscopic resection of every detected lesion;\n4. TCM syndrome differentiation of \"spleen deficiency with dampness-heat\";\n5. Signed informed consent and willingness to comply with long-term follow-up. a: High-quality colonoscopy criteria: Boston Bowel Preparation Scale score ≥ 6, cecal intubation confirmed by visualization of the ileocecal valve, and withdrawal time (excluding biopsy and polypectomy) ≥ 6 minutes.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded from the trial:\n\n1. Concomitant malignancy or history of malignancy in the digestive system;\n2. Personal or family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer (Lynch syndrome);\n3. History of inflammatory bowel disease;\n4. Malignancy in any other organ system within 5 years before screening, except for adequately treated thyroid carcinoma, cervical carcinoma in situ, basal or squamous cell skin carcinoma, or ductal carcinoma in situ of the breast cured by radical surgery;\n5. Clinically significant organic disorders or neuro-psychiatric conditions that may affect treatment or prognosis, including but not limited to severe cardiovascular or cerebrovascular disease, autoimmune disease, motor, haematological, gastrointestinal, respiratory, immune, circulatory, reproductive, genitourinary, or endocrine disorders; coagulation abnormalities; or serious post-procedural complications (e.g., gastrointestinal bleeding, perforation, cholangitis, intra-abdominal infection, cardiorespiratory depression, mesenteric tear, or pneumoperitoneum), serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>2.5 × the upper limit of normal (ULN), or alkaline phosphatase (ALP) \\>2 × ULN;\n6. Active gastrointestinal disease, conditions predisposing to perforation, or disorders that could substantially interfere with the absorption, distribution, metabolism, or excretion of the investigational drug, such as inability to take oral medication, uncontrolled nausea or vomiting, intestinal obstruction, or chronic diarrhoea;\n7. Within 3 months before screening, continuous use for ≥3 months of ≥2 doses per week (with \\\u003C2-week interruption) of agents potentially protective against colorectal adenoma: NSAIDs (e.g., aspirin, ibuprofen, celecoxib), metformin, berberine hydrochloride, folic acid, vitamin D, selenium, calcium, systemic immunotherapy, or Chinese patent medicines or decoctions labelled for \"tonifying spleen and augmenting qi, clearing heat and eliminating dampness\". Subjects may be enrolled after a washout of 1 month or ≥5 drug half-lives, whichever is longer;\n8. Cold-pattern manifestations such as aversion to cold, cold pain in the waist\u002Fabdomen, cold extremities, or preference for hot drinks;\n9. Pregnant or lactating women, or men and women of child-bearing potential with plans to conceive during the trial or within 7 months after trial completion;\n10. Participation in another drug or device trial within 1 month or \\\u003C 5 half-lives of the investigational agent (whichever is longer) before screening, concurrent participation in another trial, or intention to participate in any other clinical trial during this trial;\n11. Known allergy or hypersensitivity to ≥ 2 drugs or foods, or hypersensitivity to any component of the trial medication;\n12. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for enrolment (e.g., poor expected compliance, cognitive impairment).","ALL","40 Years","75 Years",{"count":20,"type":21},450,"ESTIMATED","INTERVENTIONAL",[24],"NA","This multicenter, randomized, double-blind, placebo-controlled trial will enroll 450 patients with completely resected high-risk colorectal adenoma (HR-CRA), randomly assigned (1:1) to 6 months of Shenbai Granules (SBG) or placebo, followed for 3 years post-polypectomy. Primary endpoint: 3-year cumulative incidence of metachronous HR-CRA. Secondary endpoints: incidence, number, size, distribution, histology of low-risk adenomas and serrated lesions, and colorectal cancer occurrence.",[27,28,29],"Colorectal Adenoma","High Risk","TCM","NOT_YET_RECRUITING","2025-08-11",{"date":33,"type":34},"2025-08-19","ACTUAL",{"date":36,"type":21},"2025-08-15",{"date":38,"type":21},"2028-11-30",{"name":40,"class":41},"Jiangsu Famous Medical Technology Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":59,"leadSponsor":60,"locationsCount":42},"100602408","shenbai-granules-for-preventing-recurrence-of-low-risk-colorectal-adenomas-100602408","NCT07123116","Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas","Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas: A Multicenter Randomized Controlled Clinical Trial","Inclusion Criteria:\n\nTo be eligible for this study, all of the following inclusion criteria must be met:\n\n1. Aged 40-75 years, regardless of sex;\n2. Patients with histologically confirmed high-risk adenomas undergoing initial polypectomy, with high-quality colonoscopy performed within 14 days before randomization;\n3. Complete resection of all detected lesions during colonoscopy;\n4. Meeting TCM diagnostic criteria for spleen deficiency with dampness-heat syndrome;\n5. Provision of signed informed consent and ability to comply with long-term follow-up.\n\n   1. High-quality colonoscopy is defined as: Boston Bowel Preparation Scale (BBPS) score ≥6, cecal intubation with photo-documentation and withdrawal time ≥6 minutes. If quality standards cannot be confirmed, a repeat colonoscopy is required.\n\n      \\-\n\n      Exclusion Criteria:\n\n      Subjects who meet any of the following exclusion criteria will not be enrolled in this study:\n\n1\\) Complicated with malignant tumor or having a history of malignant tumor; 2) Personal or family history of familial polyposis or hereditary nonpolyposis colorectal cancer; 3) History of inflammatory bowel disease; 4) Suffering from malignant tumors of other systems except the study disease within 5 years before screening, except for malignant tumors that have been cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery); 5) Complicated with severe organic diseases such as cardiovascular and cerebrovascular diseases, autoimmune diseases, diseases of the motor, hematological, digestive, respiratory, immune, circulatory, reproductive, urinary, or endocrine systems, or patients with neuropsychiatric diseases, abnormal coagulation function, severe postoperative complications, such as gastrointestinal bleeding, perforation, cholangitis, abdominal infection, cardiopulmonary function depression, mesenteric laceration, or pneumoperitoneum, etc., or other acute and chronic diseases that may affect treatment and prognosis; those with Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) levels exceeding 2.5 times the upper limit of normal, Alkaline Phosphatase (ALP) levels exceeding 2 times the upper limit of normal, or abnormal electrocardiogram results assessed by investigators as clinically significant; 6) Patients with active gastrointestinal diseases, at risk of gastrointestinal perforation, or suffering from other diseases that can significantly interfere with the absorption, distribution, metabolism, or excretion of the trial drug, such as inability to take oral drugs, uncontrolled nausea or vomiting, intestinal obstruction, chronic diarrhea due to extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.; 7) Having used the following treatments that may have a preventive effect on colorectal adenomas within 3 months before screening, for 3 consecutive months, at least 2 times a week, with an interruption time of less than 2 weeks: taking non-steroidal anti-inflammatory drugs such as aspirin, ibuprofen, celecoxib, etc, metformin, berberine hydrochloride, folic acid, vitamin D, selenium supplements, and calcium supplements, or maintaining systemic immunotherapy, or using Chinese patent medicines based on the indications in the instructions or Chinese herbal decoctions with the effects of invigorating spleen and replenishing qi, clearing heat and eliminating dampness; those who have undergone a washout period of 1 month or 5 half-lives of the drug whichever is longer can be enrolled; 8) Those with cold syndrome such as fear of cold, cold pain in the waist and abdomen, cold limbs, and preference for hot drinks when thirsty; 9) Pregnant or lactating women, as well as men or women of childbearing age who have plans for childbearing recently or within 7 months before the study; 10) Having participated in, or currently participating in, other clinical trials of drugs or research devices within 1 month before screening or within 5 half-lives of the trial drug whichever is longer, or planning to participate in any other clinical trials during this study; 11) Allergic constitution with a history of allergy to two or more drugs or foods or known allergy to the components of the study drug; 12) Other conditions deemed unsuitable for inclusion by the investigator, such as expected poor compliance, cognitive impairment, etc.\n\n\\-",{"count":20,"type":21},[24],"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas（LRCRA）.\n\nStudy Population: Post-resection patients with low-risk colorectal adenomas and Spleen Deficiency with Dampness-Heat Syndrome per TCM criteria.\n\nSample Size: 450 subjects (1:1 randomization; 225 per arm) accounting for ≤20% dropout.\n\nStudy Hypothesis (Exploratory) ： This exploratory trial aims to evaluate the potential efficacy and safety of Shenbai Granules, a TCM formula, in reducing LRCRA recurrence. Based on preliminary data suggesting a 32.64% relative risk reduction in LRCRA recurrence at 2 years, we hypothesize that Shenbai Granules may demonstrate clinically meaningful prevention of adenoma recurrence and offer a favorable safety profile in the target TCM syndrome population. No formal statistical hypothesis is tested.\n\nStatistical Analysis Analysis Sets: mITT (primary efficacy), PPS, SS (safety). Primary Analysis: Proportion difference (Newcombe method) and χ²\u002FFisher's exact test (stratified CMH if applicable).\n\nSensitivity analyses: PPS, tipping-point imputation for missing data. Safety: Descriptive summaries of AEs\u002FSAEs (MedDRA-coded), lab abnormalities.",[27,29,54],"Low Risk","2025-08-08",{"date":57,"type":34},"2025-08-14",{"date":36,"type":21},{"date":38,"type":21},{"name":40,"class":41},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100578991","ganyan-1-in-dry-eye-100578991","NCT06818487","Ganyan-1 in Dry Eye","Ganyan-1 in Dry Eye: A Randomized Clinical Trial","Inclusion Criteria:\n\n1\\. Age \\>=18 and Age \\\u003C=70, complaint of DED symptoms for 6 months or longer at screening.\n\n3\\. ocular surface disease index (OSDI) score of 25 or higher. 4. tear film breakup time (TFBUT) of 5 seconds or less. 5. Schirmer I test without anesthesia of 5 mm or more at 5 minutes. 6. CFS score of 4 or higher.\n\nExclusion Criteria:\n\n1. History systemic autoimmune diseases and ocular\u002Fperiocular malignancy.\n2. Clinically relevant slitlamp findings or abnormal lid anatomy.\n3. Active ocular allergies and active infection.\n4. Pregnant or lactating women.","18 Years","70 Years",{"count":71,"type":21},219,[24],"Ganyan -1 for the patients with dry eye",[75,29],"Dry Eye",[77,29,78],"Dry eye","RCT","2025-06-19",{"date":81,"type":34},"2025-06-25",{"date":83,"type":21},"2025-07-01",{"date":85,"type":21},"2027-02-01",{"name":87,"class":88},"Beijing Tongren Hospital","OTHER",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":68,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":42},"100581438","phase-2-herbal-ointment-in-treating-atopic-dermatitis-topically-100581438","NCT06850311","Herbal Ointment in Treating Atopic Dermatitis Topically","Efficacy and Safety of Herbal Topical Ointment in Treating Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n1. Between 18 and 65 years old, female or male.\n2. Atopic dermatitis fulfilling the diagnostic criteria of Hanifin\\&Rajka.\n3. Atopic dermatitis involving \\\u003C10% of BSA. (Base on the BSA result of Screening)\n4. An Investigator's Global Assessment (IGA) score of 2, 3 or 4 which corresponds to mild, moderate or severe disease. (Base on the IGA result of Screening)\n5. Female patients of child-bearing age with negative pregnancy test at screening.\n6. Female patients of child-bearing age that agree to continue using birth control measures approved by the investigator and agree not to lactate for the duration of the study.\n\nAgree to only receive stable doses of an additive-free, basic bland emollient for at least 7 days before baseline (day0) Willing to comply with study protocol and agree to sign an informed consent form.\n\nExclusion Criteria:\n\n1. Having a history of topical or systematical hypersensitivity to herbal or its excipient (e.g. vehicle) in ointment\n2. Undergoing phototherapy (e.g. UVB, PUVA) or systemic therapy (e.g. Immunosuppressive agents) within 30 days.\n3. Having used topical or oral therapy (e.g. topical corticosteroids, antibiotic, TCM) for dermatitis within 7 days before the first application of the study medication.\n4. Having a significant concurrent disease, such as: significant abnormalities in hematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetes mellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer or AIDS.\n5. Having abnormal liver or renal function (AST\u002FALT \\>3 x ULN, creatinine \\>2.0 mg\u002Fdl).\n6. Women who are lactating, pregnant or preparing to be pregnant.","65 Years",{"count":98,"type":21},66,[100,101],"PHASE2","PHASE3","Atopic dermatitis (AD), also known as atopic eczema, is a chronic inflammatory skin disorder. The current first-line recommended treatment for AD is the use of emollients, topical corticosteroids (TCS), and oral antihistamines if necessary. However, patients often have side effects like skin atrophy and telangiectasia. And there were plenty of herbal medicine which are beneficial to atopic dermatitis in ancient Chinese medicine books and records. Therefore, the purpose of this study is to develop a new topical application of traditional Chinese medicine and evaluate its clinical efficacy in AD patients. In human trial, 66 Subjects diagnosed as AD will be enrolled and treated with Sophora flavescens Aiton topical ointment. After treatment we will estimate the efficacy and record adverse events to conduct statistically analysis.\n\nThe 1st year project: (1) Expect to enroll 66 clinical subjects of AD. (2) Evaluate subjects 'symptom and proceed herbal ointment treatment. (3) Record treatment responses including adverse effect. (4) Conduct statistically analysis.\n\nThe 2nd year project: (1) Completing enrollment of 66 clinical subjects of AD. (2) Finish evaluation and treatment of all subjects. (3) Statistically analysis all collecting data (4) Discuss and analyze the outcome.",[104,105,106,107,29,108,109,110],"Atopic Dermatitis","Atopic Dermatitis (AD)","Atopic Dermatitis (Eczema)","Atopic Dermatitis Eczema","Skin Diseases","Skin Diseases, Eczematous","Skin Diseases, Genetic","RECRUITING","2025-02-23",{"date":114,"type":34},"2025-02-27",{"date":116,"type":21},"2025-03-01",{"date":118,"type":21},"2027-04-01",{"name":120,"class":88},"En Chu Kong Hospital"]