[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chinese-herbal-medicine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chinese-herbal-medicine":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"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":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100635247","phase-2-tiaoshen-anti-cancer-protocol-and-cbt-for-insomnia-and-survival-in-ovarian-cancer-100635247",false,"NCT07550205","Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer","Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer: A Multicenter Randomized Trial","Inclusion Criteria:\n\n1. Patients aged 18 to 80 years (inclusive).\n2. Performance status (PS) score of 0-2.\n3. Histologically or cytologically confirmed primary epithelial ovarian carcinoma, with postoperative FIGO stage III-IV, and scheduled to receive postoperative standard first-line platinum-based chemotherapy.\n4. Having undergone ovarian cancer debulking surgery, in a stable condition at enrollment (no active infection, no severe hepatic or renal impairment, etc.), and planned for postoperative first-line platinum-based chemotherapy.\n5. Meeting the diagnostic criteria for ovarian cancer-related insomnia (difficulty initiating sleep, sleep maintenance disturbance \\[nocturnal awakening ≥2 times\\], early morning awakening with inability to return to sleep, occurring ≥3 times per week and lasting ≥1 month).\n6. Possess the ability to comprehend assessment scales and undergo Cognitive Behavioral Therapy for Insomnia (e.g., Mini-Mental State Examination score ≥24, or education level above primary school).\n7. Voluntarily sign the informed consent form, agree to receive the study treatment, and able to independently complete a sleep diary.\n\nExclusion Criteria:\n\n1. Previous systematic treatment with Cognitive Behavioral Therapy for Insomnia.\n2. History of chronic insomnia, depression, or other psychiatric disorders prior to ovarian cancer diagnosis, AND with a Patient Health Questionnaire-9 score ≥15 and a Generalized Anxiety Disorder-7 score ≥15, AND long-term use of hypnotic or psychotropic medications.\n3. Pregnant or lactating women.\n4. Comorbid severe primary diseases of the cardiovascular, cerebrovascular, pulmonary, hepatic, renal, or hematopoietic systems.\n5. Language barriers that would prevent completion of assessments or therapy.\n6. Comorbid autoimmune diseases, congenital or acquired immunodeficiency diseases, hematological diseases, or long-term use of corticosteroids or immunosuppressants.\n7. Active hepatitis B, active tuberculosis, or other severe or uncontrolled infectious diseases.\n8. History of chronic alcohol dependence.\n9. Concurrent other primary malignant tumors (except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, etc.).\n10. Participation in any other clinical trial within 3 months prior to enrollment.\n11. Legally incompetent, or any medical or ethical reason that may hinder the continuation of the study.","FEMALE","18 Years","80 Years",{"count":20,"type":21},360,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Study Title: A Multicenter, Randomized Controlled Trial of Tiaoshen Anti-cancer Protocol Combined with Cognitive Behavioral Therapy for Insomnia in Improving Sleep and Survival in Ovarian Cancer Patients Purpose: This study aims to evaluate whether a combined therapy of traditional Chinese medicine (TCM) and modern psychotherapy can improve sleep and potentially extend survival for patients with ovarian cancer. Many patients experience severe, cancer-related insomnia, which lowers quality of life and may affect treatment outcomes.\n\nIntervention \\& Design: This is a randomized, double-blind, placebo-controlled trial conducted across multiple hospitals. Approximately 360 eligible patients with advanced ovarian cancer and significant insomnia will be enrolled.\n\nParticipants will be randomly assigned to one of two groups for the initial 18-week phase:\n\nExperimental Group: Receives the Tiaoshen Anti-cancer herbal formula granules plus standard Cognitive Behavioral Therapy for Insomnia (CBT-I).\n\nControl Group: Receives inactive placebo granules plus the same standard CBT-I. Neither the participants nor their treating doctors will know which granules are assigned during this phase. The primary goal is to compare the improvement in sleep quality between the two groups. Key secondary goals include assessing the therapy's impact on patients' anxiety, depression, overall quality of life, and the length of time before the cancer progresses (progression-free survival). All patients will receive standard-of-care chemotherapy.",[28,29,30,31,32],"Ovarian Neoplasms Malignant","Sleep Initiation and Maintenance Disorders","Medicine, Chinese Traditional","Chinese Herbal Medicine","Cognitive Behavioral Therapy",[34,35,36,37,38,39],"Ovarian Cancer","Cancer-Related Insomnia","Traditional Chinese Medicine","Cognitive Behavioral Therapy for Insomnia","Randomized Controlled Trial","Progression-Free Survival","NOT_YET_RECRUITING","2026-04-19",{"date":43,"type":44},"2026-04-24","ACTUAL",{"date":46,"type":21},"2026-05-01",{"date":48,"type":21},"2029-09-30",{"name":50,"class":51},"Shanghai Municipal Hospital of Traditional Chinese Medicine","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":60,"minAge":61,"maxAge":18,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100558320","th-tl-xb-prescription-on-reprogramming-of-lipid-metabolism-and-endothelial-injury-for-cerebral-infarction-patients-100558320","NCT06549582","Th Tl Xb Prescription on Reprogramming of Lipid Metabolism and Endothelial Injury for Cerebral Infarction Patients","Effect of Taohong Tongluo Xiaoban Prescription on Reprogramming of Lipid Metabolism and Endothelial Injury for Cerebral Infarction Patients：a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. The CT\u002FMRI examination findings were consistent with the diagnosis of Western cerebral infarction, aligning with the TCM apoplexy diagnosis. Primary stroke occurred 35±5 days ago.\n2. The National Institutes of Health Stroke Scale (NIHSS) evaluates a range of scores from 4 to 24.\n3. Coronary atherosclerotic heart disease is confirmed through coronary CT angiography. Carotid artery ultrasonography is employed to ascertain the presence or absence of plaque formation, with stable plaques exhibiting predominantly high and uneven echogenicity, while unstable plaques displayed low echo or irregular hypoechoic regions.\n4. Age range: ≥35 years to ≤80 years.\n5. First onset requires; patients with previous diseases and no sequelae such as limb paralysis should not affect the NIHSS score, and the modified Rankin scale (mRS) score should be ≤1 point.\n6. Patient informed consent must be obtained.\n7. The criteria for the syndrome of phlegm and blood stasis are as follows: Main syndrome: hemiplegia, mouth and eyes skew, speech retarding or silent, sensation diminished or disappeared; Secondary syndrome: excessive sputum, fat tongue with teeth marks on the side, dark red tongue, sublingual vein blue or tortuous, tongue spots, white or thick greasy fur, pulse slippery.\n\n   \\-\n\nExclusion Criteria:\n\n1. subarachnoid hemorrhage, transient ischemic attack, or other intracranial lesions such as intracranial tumor, aneurysm, vascular malformation, cerebral cysticercosis, intracerebral schistosomiasis, encephalitis, meningitis, hydrocephalus, and sequelae of brain trauma; Nonatherosclerotic thrombotic cerebral infarction (e.g., cardiogenic embolism, hypercoagulability disorders, endovascular shedding and arteritis);\n2. onset occurring within a range of 30 to 40 days；\n3. The patient presents with limb motor dysfunction, emotional disorder, cognitive impairment, or speech impairment resulting from pre-existing conditions (e.g., surgery, trauma, or congenital disability) prior to the onset of cerebrovascular accident.\n4. Patients with severe cardiac disease, heart failure, liver or kidney failure, malignant tumors, gastrointestinal bleeding, severe infections, or uncontrolled diabetes are excluded from the study.\n5. Individuals currently participating in other clinical trials are not eligible for inclusion.\n6. Exclusion criteria include patients with mental illness, multiple body ulcers or joint contractures.\n7. Non-compliance with treatment by patients and their families is considered an exclusion criterion.\n8. Inability to comprehend the content of informed consent and inability to provide a signature on the informed consent form are also grounds for exclusion.\n9. . Pregnant and lactating women are excluded from participation.\n\n   \\-","ALL","35 Years",{"count":63,"type":21},160,[65],"NA","This study is a prospective, open-label, randomized control trial. It is planning to include 160 cerebral infarction patients which will be randomized in a 1﹕1 fashion to receive Chinese herbal medicines combined basic medicine treatment, or to receive standard basic medicine treatment within 3 months after inclusion. Follow-up will be performed after the treatment for 3 months to evaluate the incidence and disability rates of limb impairment, language impairment, cognitive impairment, and emotional disorders. The primary outcome is modified Rankin Scale Score, which is measured by the overall distribution from 0 (no symptoms) to 6 (death). The secondary outcome include the Evaluation of Neurological Function Deficit score (National Institute of Health stroke scale scoring) and carotid atherosclerotic plaque score (Crouse scoring system for neck carotid atherosclerotic plaque scoring). Additional outcomes include laboratory indicator to analysis the reprogramming of lipid metabolism and endothelial Injury, Chinese medicine symptom and sign scoring system and biological indicators. The investigators will perform the intention-to-treat analysis for withdrawal and missing data, and estimate the health economic value.",[68,31,69,70,71],"Cerebral Infarction","Clinical Trial","Lipid Metabolism Disorder","Endothelial Injury","2024-08-11",{"date":74,"type":44},"2024-08-14",{"date":76,"type":21},"2024-10",{"date":78,"type":21},"2026-12",{"name":80,"class":51},"Yan Zhu"]