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

NCT07121088 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2023ZD0505604
• Study Type: interventional
• Target: 3,666
• Locations: 0 countries
• Sites: N/A

Brief 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

Ischemic Cerebral Infarction; Diabetes Mellitus

Keywords

diabetes mellitus; ischemic cerebral infarction; Chuanzhitongluo capsule

Outcome Measures

Primary Outcomes (1)

• Primary outcome indicator

  The proportion of patients with mRS score 0-2 at 90 days

  90days

Secondary Outcomes (3)

• BARC Type III and V Major Bleeding (Incidence %)

  1year

• 1-Year Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs) (Cumulative Incidence %)

  1year

• 1-Year All-Cause Mortality (Mortality Rate %)

  1year

Other Outcomes (4)

• Rate of Change in eGFR (mL/min/1.73 m²/year)

  Baseline, 6 months, 12 months

• 12-month Renal Composite Endpoint

  12 months

• Rate of Change in UACR (mg/g/year)

  Baseline, 6 months, 12 months

Study Arms (2)

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. TCM universal treatment plan: (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. (Sequential treatment) Chuanzhi Tongluo Capsules (Lunan Pharmaceutical), 2 capsules each time, orally, 3 times a day; administration from day 15 to day 365. TCM decoction: Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.

Drug: (Intensive treatment) Chuanzhi Tongluo Capsules; Drug: (Sequential treatment) Chuanzhi Tongluo Capsules; Drug: TCM Syndrome Differentiation Decoction

Standard Treatment Only

ACTIVE COMPARATOR

Guideline-based treatment for cerebral infarction with diabetes: aspirin (100 mg/day) + clopidogrel (75 mg/day) + atorvastatin (20 mg/day) + metformin (500 mg bid). Other antiplatelet/antidiabetic drugs may be added per clinician discretion.

Other: Standard Treatment (Guideline-Based)

Interventions

(Intensive treatment) Chuanzhi Tongluo Capsules DRUG

4 capsules each time, orally, 3 times a day; administration from day 1 to day 14 of the disease.

Chuanzhitongluo capsule+Standard Treatment

Standard Treatment (Guideline-Based) OTHER

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.

Standard Treatment Only

(Sequential treatment) Chuanzhi Tongluo Capsules DRUG

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

Chuanzhitongluo capsule+Standard Treatment

TCM Syndrome Differentiation Decoction DRUG

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

Chuanzhitongluo capsule+Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, regardless of gender.
• 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:
• Fasting blood glucose ≥ 7.0 mmol/L.
• hour postprandial blood glucose ≥ 11.1 mmol/L.
• Glycated hemoglobin ≥ 6.5%.
• Acute cerebral infarction meets the diagnostic criteria of \*Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023\*:
• Acute onset.
• Focal neurological deficits, with a few cases showing global neurological deficits.
• The presence of a responsible lesion on imaging or symptoms/signs persisting for more than 24 hours.
• Onset of cerebral infarction \< 48 hours.
• 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)).
• Modified Rankin Scale (mRS) before onset: 0 - 1 point.
• National Institutes of Health Stroke Scale (NIHSS) at admission: 4 - 24 points.
• Signed informed consent form.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Tao Huang, doctor

CONTACT

18688898958; arteries@163.com

zheng zhen, master

CONTACT

19120517600; devotetcm@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: August 13, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08