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NCT07121088
PHASE4

Traditional Chinese Medicine Intervention for Ischemic Cerebrovascular Disease and Diabetes Mellitus: An Efficacy Comparative Study

Sponsor: Guangzhou University of Traditional Chinese Medicine

View on ClinicalTrials.gov

Summary

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 \<48 hours and comorbid diabetes. The primary question it aims to address is: Can 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.

Official title: Comparative Effectiveness Study of Traditional Chinese Medicine Intervention in Ischemic Cerebrovascular Disease Comorbid With Diabetes Mellitus

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3666

Start Date

2025-08-31

Completion Date

2027-12-31

Last Updated

2025-08-13

Healthy Volunteers

No

Interventions

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.

OTHER

Standard Treatment (Guideline-Based)

Combination therapy including: 1. Antiplatelet: aspirin 100 mg/day + clopidogrel 75 mg/day. 2. Lipid-lowering: atorvastatin 20 mg/day. 3. Antidiabetic: metformin 500 mg bid (max 2000 mg/day). \*Doses may be adjusted per local guidelines or patient tolerance.

DRUG

(Sequential treatment) Chuanzhi Tongluo Capsules

2 capsules each time, orally, 3 times a day; administration from day 15 to day 365.

DRUG

TCM Syndrome Differentiation Decoction

Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.