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

Coronary Heart Disease Clinical Trial

Official title:

Yangxinshi Pills Plus Conventional Treatment Versus Placebo Plus Conventional Treatment on the Exercise Tolerance of the Patients With Coronary Heart Disease: a Multi-center,Randomised Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03478332
• Other study ID #: GFH-C04
• Status: Recruiting
• Phase: Phase 2
• First received: February 11, 2018
• Last updated: March 20, 2018
• Start date: June 1, 2017
• Est. completion date: August 25, 2020

Study information

• Verified date: March 2018
• Source: Affiliated Hospital of Changchun University of Chinese Medicine
• Contact: Xiaoping Meng, Doctor
• Phone: 8618994127461
• Email: 18994127461[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 25, 2020
• Est. primary completion date: May 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Yangxinshi pill
0.6g/tablet
• conventional coronary heart disease medicine
the conventional treatment includes medicines treating coronary heart disease
• Placebos
Yangxinshi simulant

Locations

Country	Name	City	State
China	Changchun Traditional Medicine University Affiliated Hospital	Chang Chun	Ji Lin

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Changchun University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Number of treatment-related adverse events as assessed by CTCAE4.0	24 months
Primary	change in the maximum volume of O2 consumption	measured by gas analyzer	from baseline to 6 months
Secondary	change in exercise tolerance	assessed by the distance (in meters) walked on 6-minute walk test	from baseline to 6 months
Secondary	change in left ventricular ejection fraction (in percentage)	assessed by echocardiographic examination	from baseline to 6 months