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A Randomized Double-blind Placebo-controlled Parallel Study Evaluating the Efficacy of Rendongteng Decoction in Treating Syndrome of Intermingled Stasis and Toxin Based on the Principle of 'Treating Different Diseases with the Same Method'

A Randomized Double-blind Placebo-controlled Parallel Study Evaluating the Efficacy of Rendongteng Decoction in Treating Syndrome of Intermingled Stasis and Toxin Based on the Principle of 'Treating Different Diseases with the Same Method'

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000903
Enrollment
Unknown
Registered
2026-04-03
Start date
2024-06-30
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, Stable Angina Pectoris of Coronary Heart Disease

Interventions

Treatment group:Oral Rendongteng Decoction
Control Group:Oral Placebo Granules

Sponsors

Beijing University of Chinese Medicine Dongzhimen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Ischemic Stroke Meet diagnostic criteria for ischemic stroke; 2) TCM syndrome differentiation confirming intermingled stasis and toxin; 3) hs-CRP =1.5mg/L; 4) NIHSS score 2-22; 5) Age 40-80 years, any gender; 6) Voluntary participation with signed informed consent. 2. Stable Angina Pectoris of Coronary Heart Disease 1) Meet diagnostic criteria for stable angina pectoris; 2) TCM syndrome differentiation confirming intermingled stasis and toxin; 3) hs-CRP =1.5mg/L; 4) CCS angina classification I-III, including asymptomatic, stable exertional angina, other types of angina, or ACS stabilized for >1 month; 5) Age 40-80 years, any gender; 6) Voluntary participation with signed informed consent. Note: For patients meeting both disease criteria, group assignment based on most recent diagnosis.

Exclusion criteria

Exclusion criteria: 1) Ischemic Stroke: 1)Stroke caused by brain tumor, trauma, or hematologic disease; 2) Comorbid conditions affecting limb function (e.g., claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis) interfering with neurological examination; 3) Severe arrhythmia, atrial fibrillation, or heart failure; 4) Poorly controlled hypertension (SBP >160mmHg and/or DBP >100mmHg); severe airway dysfunction requiring intubation/ventilation. 2) Stable Angina Pectoris: 1) Recent myocardial infarction (160mmHg and/or DBP >100mmHg); 5) Prophylactic nitrate use within 7 days pre-screening for angina relief (e.g., isosorbide mononitrate, isosorbide dinitrate) unwilling to discontinue during non-episode periods. 3) Others: 1) Severe hepatic/renal/hematopoietic/endocrine/respiratory disorders (liver enzymes >1.5×ULN, Cr >normal, platelets <normal); 2) Allergic constitution or known allergy to trial drugs; 3) Pregnant/lactating women or those planning pregnancy; 4) Active ulcers/bleeding tendency, long-term anticoagulant use (e.g., warfarin); 5) Current antibiotic use; 6) Life-threatening conditions affecting follow-up; 7) Other diseases limiting efficacy evaluation; 8) Participation in other drug trials within 4 weeks.

Design outcomes

Primary

MeasureTime frame
Reduction in Hs-CRP;

Secondary

MeasureTime frame
Reduction in Syndrome Score of Intermingled Stasis and Toxin;IL-6;IL-1ß;NIHSS Scale;VAS Score for Typical Symptoms;Reduction/Discontinuation Rate of Emergency Medications;

Countries

China

Contacts

Public ContactWu Shengxian

Beijing University of Chinese Medicine Dongzhimen Hospital

shengxianwu@126.com13501382919

Outcome results

None listed

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