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A multicenter, randomized, double blind, placebo controlled clinical trial for Huoxinwan in the treatment of coronary heart disease with stable angina pectoris

A multicenter, randomized, double blind, placebo controlled clinical trial for Huoxinwan in the treatment of coronary heart disease with stable angina pectoris

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17010929
Enrollment
Unknown
Registered
2017-03-20
Start date
2015-07-22
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

coronary heart disease with stable angina pectoris

Interventions

treatment group:Huoxinwan
control group:Placebo of Huoxinwan

Sponsors

Fuwai Hospital Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Objective diagnosis of coronary heart disease (in line with any one of the following); (1) a clear history of myocardial infarction = 6 months, or percutaneous coronary intervention (PCI) history = 6 months, or coronary artery bypass (CABG) history = 6 months; (2) coronary angiography (at least one coronary artery stenosis = 50%) or coronary CTA suggest luminal stenosis = 50%; (3) exercise load or drug load nuclide examination for the diagnosis of coronary heart disease myocardial ischemia. 2. Meet the diagnostic criteria for chronic stable angina pectoris in Western medicine; 3. In line with the standard of TCM deficiency and blood stasis syndrome; 4. Canadian Cardiovascular Association (CCS) angina pectoris grade I~III; 5. The past use of ß-blockers, should be used regularly for more than 3 months; 6. Number of angina attacks = 2 times / week and = 6 times/day; 7. Between 30 and 75 years of age; 8. Subjects who are informed and willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. severe heart disease (unstable angina, severe arrhythmia, etc.), severe cardiopulmonary dysfunction (cardiac function III, IV or cardiac ultrasound left ventricular ejection fraction (LVEF) 2 times the normal reference value of the upper limit, or Cr> 1.5 times the normal reference limit), combined with hematopoietic system and other serious primary disease, 8. Any other serious illness or condition such as: Malignant neoplasms; 9. Pregnancy, lactating women or pregnant planners; 10. Participate in other clinical researchers for nearly three months; 11. Allergies or allergies to known ingredients of research drugs; 12. Researchers believe that should not participate in clinical researchers.

Design outcomes

Primary

MeasureTime frame
The attack frequency of angina pectoris;

Secondary

MeasureTime frame
Nitroglycerin stopped reduction rate and the change of usage;Seattle Angina Questionnaire, SAQ;TCM syndrome classification score;Blood lipid fasting glucose Coagulation four;

Countries

China

Contacts

Public ContactLihong Ma

Fuwai Hospital Chinese Academy of Medical Sciences

mlh4463@163.com+86 18601902828

Outcome results

None listed

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