Efficacy and Safety of Yangxin Shengmai Granules for the Treatment of Stable Angina Pectoris

Last updated: November 11, 2020
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Not Recruiting

Phase

4

Condition

Hypercholesterolemia

Chest Pain

Heart Disease

Treatment

N/A

Clinical Study ID

NCT04270071
YXSM_2019001
  • Ages 40-75
  • All Genders

Study Summary

This study is a randomized, double-blind, placebo-controlled, parallel clinical trial in Chinese population with stable angina pectoris. The purpose is to determine the efficacy and safety of Yangxin Shengmai Granules in the treatment of stable angina pectoris.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants are aged between 40 and 75 years.
  • Meet the diagnostic criteria of stable angina pectoris.
  • Meet Chinese medicine syndrome differentiation of Qi-yin deficiency and blood stasissyndrome.
  • Voluntarily participate and sign informed consent.

Exclusion

Exclusion Criteria:

  • Patients were diagnosed as acute myocardial infarction, unstable angina, stableexertion angina and other heart diseases.
  • Patients with poor control of hypertension and diabetes, severe cardiopulmonaryinsufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter,paroxysmal ventricular tachycardia, etc.), with a history of heart pacemaker orcerebrovascular disease within one year.
  • Any of the following disease history or evidence was found in the screening period:severe cardiovascular or cerebrovascular diseases; active, recurrent peptic ulcer orother bleeding risk diseases; other serious diseases of digestive system; combinedwith malignant tumor, blood system disease, serious or progressive diseases of theother system; combined with mental diseases.
  • Before screening, any laboratory inspection index meets the following standards: Theresults showed that Glutamic aspartate transaminase (AST) or alanine aminotransferase (ALT) were more than 1.5 times of the upper limit of normal value and serum creatinine (Cr) was more than 1.2 times of the upper limit of normal value.
  • With a history of alcohol and drug abuse.
  • Pregnant or lactating women.
  • Patients who have participated in clinical trials of other drugs within 3 monthsbefore enrollment.

Study Design

Total Participants: 80
Study Start date:
December 01, 2020
Estimated Completion Date:
December 31, 2021

Study Description

Yangxin Shengmai granules is a Chinese patent medicine composed of ginseng, Ophiopogon japonicus, Salvia miltiorrhiza, Schisandra chinensis, etc. It is used for the treatment of chest pain caused by Qi-yin deficiency and blood stasis in traditional Chinese medicine. The symptoms include chest tightness, chest pain, palpitation, shortness of breath, fatigue, dry mouth and dry throat. Clinical applications suggested that Yangxin Shengmai granules were safe and effective in the treatment of coronary heart disease. However, high-quality clinical trials are still needed to further confirm, so as to provide theoretical basis for the treatment of stable angina pectoris with traditional Chinese medicine.

The study is designed to determine the efficacy and safety of Yangxin Shengmai Granules in the treatment of stable angina pectoris.