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

NCT07121088 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3666

Last updated 2025-08-13

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Guangzhou University of Traditional Chinese Medicine

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-12-31
Completion
2027-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07121088 on ClinicalTrials.gov