NCT03478332

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Affiliated Hospital of Changchun University of Chinese Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DRUG	Yangxinshi pill	0.6g/tablet
DRUG	conventional coronary heart disease medicine	the conventional treatment includes medicines treating coronary heart disease
DRUG	Placebos	Yangxinshi simulant

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-05-02
• Completion: 2020-08-25
• First posted: 2018-03-27
• Last updated: 2018-03-27

Locations

1 site across 1 country: China