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Randomized, double-blind, placebo-controlled multi-center clinical study about the repair of Tong Mai Yang Xin Pill on Stable Coronary Heart Disease Angina pectoris myocardial injury

Randomized, double-blind, placebo-controlled multi-center clinical study about the repair of Tong Mai Yang Xin Pill on Stable Coronary Heart Disease Angina pectoris myocardial injury

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-14005714
Enrollment
Unknown
Registered
2014-12-14
Start date
2014-05-30
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Stable Coronary Heart Disease Angina pectoris

Interventions

the placebo group:Western standard treatment plus placebo (just like tongmai Yang Xin Wan, production units: Tianjin Zhongxin Pharmaceutical Group Co., Ltd. lerentang pharmaceutical) medicine method:
medication time: 12 weeks.
the experimental group:Western standard treatment + tongmai Yang Xin Wan (production units: Tianjin Zhongxin Pharmaceutical Group Co., Ltd. lerentang pharmaceutical), medication methods: 40 / times, 2
taking time: 12 weeks

Sponsors

Institute of Basic Theory of TCM, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. in line with Western diagnostic criteria for chronic stable angina; 2. TCM belongs to Qi and Yin deficiency syndrome of angina pectoris; 3. NYHA functional class grade II or III; 4. To be aged 50 to 75 years; 5. signed informed consent; 6. there are indicators of myocardial injury: BNP more than 500ng/L; echocardiography E/A less than 1 (without high blood pressure, heart disease); echocardiography Action figure LVEF <50% (exclude hypertension, rheumatic heart disease, cardiomyopathy); sensitive troponin exceed the upper limit of normal. Note: meet from 1 to 6, before inclusion.

Exclusion criteria

Exclusion criteria: 1. Conducted a coronary revascularization within 3 months; 2. resting ECG has following abnormalities: complete left bundle branch block, WPW syndrome, ventricular pacing; 3. merge uncontrolled symptomatic heart failure or left ventricular ejection fraction echocardiography prompted less than 40%; 4. the need for treatment of rapid or slow arrhythmias; 5. the known renal insufficiency, male serum creatinine more than 2.5mg/dl, females more than 2.0mg/dl; known liver dysfunction, ALT more than 2 times the normal value; 6. combined with tumor, primary hematopoietic system and other serious diseases and the mentally ill; 7. made surgery and bleeding tendencies within 4 weeks; 8. Participating in other clinical trials are within 8 months; 9. known allergy or allergic constitution to medicines of the preparations; 10. himself or immediate family who have previously taken fleece-flower root and its preparations history of liver dysfunction.

Design outcomes

Primary

MeasureTime frame
BNP and high sensitive troponin absolute value;EF value, E / A (quantitative detection);Quality of life (Seattle Angina Scale);TCM Syndrome;The incidence of major cardiovascular events;

Secondary

MeasureTime frame
Demographic data: age, gender, height, weight, ethnicity, occupation.;Clinical data: history, course, treatment history, physical examination, and other comorbidities and medication;Vital signs (temperature, heart rate, respiration, pulse, blood pressure);Laboratory tests: blood and urine routine tests; liver function (ALT, AST, ALP, gama-GGT, TBIL); renal function (Cr, BUN); coagulation (PT, TT, APTT, FIB).;

Countries

China

Contacts

Public ContactHU Jingqing
gcp306@126.com+86 010-64014411-2525

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026