[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602252":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":41,"locations":28,"responsibleParty":51,"collaborators":28,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":28,"enrollmentInfo":63,"targetDuration":28,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":77,"whyStopped":28,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":28},{"fullName":5,"class":6},"Guangzhou University of Traditional Chinese Medicine","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Chuanzhitongluo capsule+Standard Treatment","EXPERIMENTAL","On the basis of standard treatment, a combined treatment plan of TCM universal treatment and syndrome-specific treatment was given.\n\nTCM universal treatment plan:\n\n(Intensive treatment) Chuanzhi Tongluo Capsules (Lunan Pharmaceutical), 4 capsules each time, orally, 3 times a day; administration from day 1 to day 14 of the disease.\n\n(Sequential treatment) Chuanzhi Tongluo Capsules (Lunan Pharmaceutical), 2 capsules each time, orally, 3 times a day; administration from day 15 to day 365.\n\nTCM decoction: Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.",[13,14,15],"Drug: (Intensive treatment) Chuanzhi Tongluo Capsules","Drug: (Sequential treatment) Chuanzhi Tongluo Capsules","Drug: TCM Syndrome Differentiation Decoction",{"label":17,"type":18,"description":19,"interventionNames":20},"Standard Treatment Only","ACTIVE_COMPARATOR","Guideline-based treatment for cerebral infarction with diabetes: aspirin (100 mg\u002Fday) + clopidogrel (75 mg\u002Fday) + atorvastatin (20 mg\u002Fday) + metformin (500 mg bid). Other antiplatelet\u002Fantidiabetic drugs may be added per clinician discretion.",[21],"Other: Standard Treatment (Guideline-Based)",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","(Intensive treatment) Chuanzhi Tongluo Capsules","4 capsules each time, orally, 3 times a day; administration from day 1 to day 14 of the disease.",[9],null,{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Standard Treatment (Guideline-Based)","Combination therapy including: 1. Antiplatelet: aspirin 100 mg\u002Fday + clopidogrel 75 mg\u002Fday. 2. Lipid-lowering: atorvastatin 20 mg\u002Fday. 3. Antidiabetic: metformin 500 mg bid (max 2000 mg\u002Fday). \\*Doses may be adjusted per local guidelines or patient tolerance.",[17],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"(Sequential treatment) Chuanzhi Tongluo Capsules","2 capsules each time, orally, 3 times a day; administration from day 15 to day 365.",[9],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"TCM Syndrome Differentiation Decoction","Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.",[9],[42,47],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},"Tao Huang, doctor","CONTACT","18688898958","arteries@163.com",{"name":48,"role":44,"phone":49,"phoneExt":28,"email":50},"zheng zhen, master","19120517600","devotetcm@163.com",{"type":52,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100602252","phase-4-traditional-chinese-medicine-intervention-for-ischemic-cerebrovascular-disease-and-diabetes-mellitus-an-efficacy-comparative-study-100602252",false,"NCT07121088","Traditional Chinese Medicine Intervention for Ischemic Cerebrovascular Disease and Diabetes Mellitus: An Efficacy Comparative Study","Comparative Effectiveness Study of Traditional Chinese Medicine Intervention in Ischemic Cerebrovascular Disease Comorbid With Diabetes Mellitus","TIDES","Inclusion Criteria:\n\n1. Age ≥ 18 years old, regardless of gender.\n2. Previously diagnosed with diabetes, or with an unknown medical history, meeting the WHO 2023 diagnostic criteria for type 2 diabetes, including any of the following:\n\n   * Fasting blood glucose ≥ 7.0 mmol\u002FL.\n   * 2-hour postprandial blood glucose ≥ 11.1 mmol\u002FL.\n   * Glycated hemoglobin ≥ 6.5%.\n3. Acute cerebral infarction meets the diagnostic criteria of \\*Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023\\*:\n\n   * Acute onset.\n   * Focal neurological deficits, with a few cases showing global neurological deficits.\n   * The presence of a responsible lesion on imaging or symptoms\u002Fsigns persisting for more than 24 hours.\n   * Exclusion of non-vascular etiologies.\n   * Exclusion of intracerebral hemorrhage by brain CT\u002FMRI.\n4. Onset of cerebral infarction \\\u003C 48 hours.\n5. TCM syndrome conforms to the \"toxin damaging brain collaterals\" syndrome (referring to the diagnostic criteria (draft) of \\*Research on the Diagnostic Criteria for the Syndrome of Mutual Binding of Stasis and Toxin in Ischemic Cardiovascular and Cerebrovascular Diseases\\* (Ju Jianqing et al., 2023)).\n6. Modified Rankin Scale (mRS) before onset: 0 - 1 point.\n7. National Institutes of Health Stroke Scale (NIHSS) at admission: 4 - 24 points.\n8. Signed informed consent form.","ALL","18 Years",{"count":64,"type":65},3666,"ESTIMATED","INTERVENTIONAL",[68],"PHASE4","The objective of this observational study is to understand the long-term effects of traditional Chinese medicine (TCM) intervention on patients with cerebral infarction onset within \\\u003C48 hours and comorbid diabetes. The primary question it aims to address is:\n\nCan long-term TCM intervention for the treatment of ischemic cerebrovascular disease comorbid with diabetes improve patients' neurological deficits and self-care ability? Participants receiving TCM intervention (universal treatment combined with syndrome-specific treatment) as part of routine cerebrovascular disease management will undergo follow-up assessments at 30 days, 90 days, 6 months, and 12 months within 1 year to evaluate neurological status (e.g., mRS score, NIHSS score) and quality of life indicators.",[71,72],"Ischemic Cerebral Infarction","Diabetes Mellitus",[74,75,76],"diabetes mellitus","ischemic cerebral infarction","Chuanzhitongluo capsule","NOT_YET_RECRUITING","2025-08-12",{"date":80,"type":81},"2025-08-13","ACTUAL",{"date":83,"type":65},"2025-08-31",{"date":85,"type":65},"2027-12-31",{"name":5,"class":6}]