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A multicenter, randomized, double-blind, placebo parallel controlled study to evaluate the efficacy and safety of Yangxin Shengmai Granules in the treatment of stable angina pectoris in patients with coronary heart disease

A multicenter, randomized, double-blind, placebo parallel controlled study to evaluate the efficacy and safety of Yangxin Shengmai Granules in the treatment of stable angina pectoris in patients with coronary heart disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088123
Enrollment
Unknown
Registered
2024-08-12
Start date
2020-08-04
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

stable angina pectoris of coronary heart disease

Interventions

treatment group:Accept Yangxin Shengmai Granules, 1 bag each time, 3 times a day
control group:Accept the Yangxin Shengmai Granule Simulator, 1 bag each time, 3 times a day.

Sponsors

Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of Western medicine for stable angina pectoris of coronary heart disease; 2. Traditional Chinese medicine differentiation is characterized by deficiency of both qi and yin; 3. 30-75 years old (including 30 and 75 years old), regardless of gender; 4. The patient or their legal representative signs an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with acute myocardial infarction, unstable angina, stable exertion angina, grade IV, and other heart diseases; 2. Patients with hypertension and diabetes under poor control, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), who have used cardiac pacemaker and Cerebrovascular disease within one year; 3. During the screening period, there is a history or evidence of any of the following diseases: Severe cardio cerebral Vascular disease Active, recurrent peptic ulcer or other bleeding related diseases Other serious digestive system diseases Merging malignant tumors, hematological diseases, or other serious or progressive systemic diseases Patients who are unable or unwilling to cooperate due to the merger of other mental illnesses 4. Any laboratory test indicator that meets the following standards before screening: Indication of liver and kidney function upon admission: ALT, AST>1.5 times the upper limit of normal value, Cr>1.2 times the upper limit of normal value (refer to the range of normal values in the laboratory of the research center where the patient is located), other clinically significant laboratory test abnormalities, and the situation where the researcher determines that admission is not suitable 5. Suspect or have a history of alcohol or drug abuse; 6. Pregnant, lactating women or those who have recently planned pregnancy and are unwilling to use contraception; 7. Patients who have participated in clinical trials of other drugs within the first 3 months of enrollment; 8. Researchers believe that patients should not participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
The withdrawal rate of Nitroglycerin tablets after 4 weeks of treatment;

Secondary

MeasureTime frame
Changes in angina symptom score from baseline after 2 and 4 weeks of treatment;Evaluation of clinical outcomes reported by patients with coronary heart disease and angina pectoris after 2 and 4 weeks of treatment (CHD-PRO);

Countries

China

Contacts

Public ContactLi Jun

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

13051458913@163.com+86 130 5145 8913

Outcome results

None listed

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