Clinical trial NCT04270071: Efficacy and Safety of Yangxin Shengmai Granules for the Treatment of Stable Angina Pectoris
Official title: Efficacy and Safety of Yangxin Shengmai Granules for the Treatment of Stable Angina Pectoris: Randomised, Double Blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Heart Disease
Stable Angina
Keywords: Yangxinshengmai granules
Stable angina pectoris
Coronary heart disease
Randomized controlled trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 stasis syndrome.
* Voluntarily participate and sign informed consent.

Exclusion Criteria:

* Patients were diagnosed as acute myocardial infarction, unstable angina, stable exertion angina and other heart diseases.
* Patients with poor control of hypertension and diabetes, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), with a history of heart pacemaker or cerebrovascular 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 or other bleeding risk diseases; other serious diseases of digestive system; combined with malignant tumor, blood system disease, serious or progressive diseases of the other system; combined with mental diseases.
* Before screening, any laboratory inspection index meets the following standards: The results 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 months before enrollment.

Primary outcomes:
measure: Stopping or reducing rate of the nitroglycerin tablets
timeFrame: Four weeks after treatment
Secondary outcomes:
measure: Changes of angina symptom score
timeFrame: Two and four weeks after treatment
measure: Patient-reported outcomes in coronary heart disease
timeFrame: Two and four weeks after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Jun Li, MD
role: STUDY_DIRECTOR
References:
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citation: Yang X, He T, Han S, Zhang X, Sun Y, Xing Y, Shang H. The Role of Traditional Chinese Medicine in the Regulation of Oxidative Stress in Treating Coronary Heart Disease. Oxid Med Cell Longev. 2019 Feb 24;2019:3231424. doi: 10.1155/2019/3231424. eCollection 2019.
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