Effect of Yangxinshumai Granule on Chronic Stable Angina Pectoris by Lipidomics: A Multicenter Randomized Placebo-Controlled Trial

Phase 2

Conditions: Chronic Stable Angina Pectoris

Registration Number: ITMCTR2100005419

Lead Sponsor: Jiangsu Province Hospital of Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Subject aged between 35 and 80 years old, unrestricted gender for male or female.
2.Subject's coronary CT or coronary angiography confirmed that at least one major branch of the coronary artery had stenosis at least 50%.
3.Subject has angina pectoris for more than 3 months, at least twice a week on baseline, and there was no significant change in the frequency, severity, nature, and inducing and relieving factors of angina pectoris at baseline.
4.Subject has deficiency of both Qi and Yin in TCM syndrome.
5.Subject voluntarily participates in the trial and signs informed consent.

Exclusion Criteria

1.Subject plans to undergo Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG) in the near future.
2.Subject has previous myocardial infarction.
3.Subject has severe cardiovascular disease (including: refractory heart failure, cardiogenic shock, valvular heart disease, severe arrhythmia).
4.Subject has atrial fibrillation.
5.Subject has primary cardiomyopathy.
6.Subject has severe respiratory disease.
7.Subject has poor blood pressure control (systolic blood pressure at least 180mmHg or diastolic blood pressure at least 110mmHg).
8.Subject's fasting blood glucose > 11.1mmol/L.
9.Subject has other serious primary diseases that cannot be effectively controlled, such as severe liver and kidney diseases, malignant tumors, pernicious anemia, etc..
10.Subject with pregnancy or lactating.
11.Subject has taken Chinese medicines or Chinese patent medicines that have the effect of treating coronary heart disease within one months before enrollment.
12.Subject currently participates in other drug clinical trials.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
frequency of angina pectoris;

Secondary Outcome Measures

Name	Time	Method
lipid profile;time-domain parameters of heart rate variability (HRV);traditional Chinese medicine syndrome scores;nitroglycerin usage;seattle angina pectoris scale;