Effects of Yangxinshi Pills on the Exercise Tolerance of the Patients With Coronary Heart Disease

Phase 2

• Conditions: Coronary Heart Disease
• Interventions: Drug: Yangxinshi pill; Drug: conventional coronary heart disease medicine; Drug: Placebos

• Registration Number: NCT03478332
• Lead Sponsor: Affiliated Hospital of Changchun University of Chinese Medicine

Brief Summary

Compared with conventional treatment of the coronary heart disease,the aim of the research is to find out if the addition of Yangxinshi pills on the basis of conventional treatment can improve exercise tolerance of patients with coronary heart disease, improve quality of life or restore social function and mental health

Detailed Description

90 outpatients with clear diagnosis of coronary heart diseases will be recruited in the trial and randomized into two group.

One group are treated with Yangxinshi pills (provided by Qingdao Growtful Pharmaceutical Co., Ltd.) plus conventional medicine, the other group are treated with placebo plus conventional medicine.

The primary end point is VO2max measured by cardiopulmonary exercise test after 3 months of treatment.

The secondary endpoint is:

1. Mets, Anaerobic threshold（AT）measured by cardiopulmonary exercise test；

2. Changes of other composite indicators of treadmill exercise test or cardiopulmonary exercise test；

3. The maximum walking distance of 6-minute walk test;

4. Changes of Seattle Angina Questionnaire;

5. Hamilton Depression Scale/ Hamilton Anxiety Scale.

The safety evaluation criteria is:

1. Adverse event and serious adverse event;

2. Vital signs;

3. Resting 12 lead ECG;

4. Blood routine examination , urine routine examination、liver and renal function examination(AST、ALT、BUN、Cr).

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2018-02-11
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-20
• Last Update Submitted: 2018-03-20
• Study First Posted: 2018-03-27
• Last Update Posted: 2018-03-27
• Primary Completion: 2020-05-02
• Study Completion: 2020-08-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Age 40 ~ 75, gender is not limited
• Have a clear history or ECG of hospital myocardial infarction , diagnosed as coronary heart disease by imaging diagnosis
• Sign the informed consent voluntarily

Exclusion Criteria

• History of hospitalization for acute coronary syndrome in past 3 months
• Uncontrolled grade 3 hypertension（≥180/100mmHg）or hypotension（<90/60mmHg）
• History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) or lower extremity arterial disease in the past 6 months
• In past 6 months, have medical history of: pregnancy, prepare or suspected of pregnancy, abortion, breastfeeding or after childbirth
• Combined episode bronchial asthma or chronic obstructive pulmonary disease, bradycardia (resting heart rate <60bpm) or atrioventricular block
• Severely allergic constitution, known or likely to be allergic to the test drug or its components
• Known bleeding tendency or hemorrhagic disease
• Patients with severe liver and kidney dysfunction (creatinine clearance ≤ 40ml / min or in the active stage of kidney disease, serum aminotransferase ≥ 2 × upper limit of clinical reference), other life-threatening serious primary or psychiatric diseases and malignant tumors
• Any other situations that researchers believe may affect the clinical research

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	conventional coronary heart disease medicine	The aim of the arm is to test if the addition of Yangxinshi pills to the conventional coronary heart disease medicine will improve the exercise tolerance of the coronary heart disease
Treatment group	Yangxinshi pill	The aim of the arm is to test if the addition of Yangxinshi pills to the conventional coronary heart disease medicine will improve the exercise tolerance of the coronary heart disease
Control group	conventional coronary heart disease medicine	The patients of the control group are treated with conventional coronary heart disease medicine plus the placebos-Yangxinshi simulant
Control group	Placebos	The patients of the control group are treated with conventional coronary heart disease medicine plus the placebos-Yangxinshi simulant

Primary Outcome Measures

Name	Time	Method
change in the maximum volume of O2 consumption	from baseline to 6 months	measured by gas analyzer

Secondary Outcome Measures

Name	Time	Method
change in exercise tolerance	from baseline to 6 months	assessed by the distance (in meters) walked on 6-minute walk test
change in left ventricular ejection fraction (in percentage)	from baseline to 6 months	assessed by echocardiographic examination

Trial Locations

Locations (1)

Changchun Traditional Medicine University Affiliated Hospital; 🇨🇳 Chang Chun, Ji Lin, China