A Study on the Integrated Traditional Chinese and Western Medicine Regimen Targeting Key Syndromes in Different Stroke Populations for Reducing the Risk of Vascular Events - A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Tongren Niuhuang Qingxin Pills Combined with Conventional Western Medical Treatment for Reducing the Risk of Vascular Events in Ischemic Stroke Patients with Phlegm-Heat Pattern

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2026000867

Enrollment

Unknown

Registered

2026-04-02

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischemic stroke

Interventions

Experimental Group:The patients received basic treatment combined with Tong Ren Cow Gallbladder Calming Heart Pills (3g per pill), orally, 1 pill per dose, twice daily, for a course of 90 days

Basic treatment: All enrolled patients were given standardized Western medical treatment, following the recommendations of the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Str

Control Group:The patients received basic treatment combined with Tong Ren Cow Gallbladder Calming Heart Pills placebo at a dose of 3g (1 pill), orally, 1 pill per dose, twice daily, for a 90-day cour

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Compliant with the diagnostic criteria for ischemic stroke as per the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023)"; 2. Yellow and greasy tongue coating; 3. Within 72 hours of onset; 4. ESRS score = 3 points; 5. TOAST classification as large artery atherosclerosis type; 6. Age = 18 years; 7. Patient or legal guardian has been informed and has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. GCS 2×ULN) or renal dysfunction (Cr >1.5×ULN); 4. Life-threatening conditions with <1 year life expectancy; 5. Allergy to Tongren Niuhuang Qingxin Wan or its components; 6. Pregnancy, planned pregnancy, or lactation; 7. Current participation in other interventional trials.

Design outcomes

Primary

Measure	Time frame
Composite vascular events;	—

Secondary

Measure	Time frame
Composite vascular event rate;Change in neurological deficit severity (National Institutes of Health Stroke Scale) compared to baseline.;Phlegm-heat symptom score change;The proportion of participants with a modified Rankin Scale score of 0-1.;The change in Montreal Cognitive Assessment scores compared to baseline.;Changes in Activities of Daily Living (ADL) Barthel Index score and EuroQol Five Dimensions Questionnaire (EQ-5D) score from baseline.;Patient-Reported Outcome Assessment;	—

Measure

Time frame

Composite vascular event rate;Change in neurological deficit severity (National Institutes of Health Stroke Scale) compared to baseline.;Phlegm-heat symptom score change;The proportion of participants with a modified Rankin Scale score of 0-1.;The change in Montreal Cognitive Assessment scores compared to baseline.;Changes in Activities of Daily Living (ADL) Barthel Index score and EuroQol Five Dimensions Questionnaire (EQ-5D) score from baseline.;Patient-Reported Outcome Assessment;

—

Countries

China

Contacts

Public ContactKegang Cao

Dongzhimen Hospital, Beijing University of Chinese Medicine

kgdoctor@sina.com13141229707

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026