NCT05978089

Effect of Yangxinshi Tablet on Exercise Tolerance in Patients With Chronic Coronary Syndrome（MET STUDY）

Efficacy and Safety of Yangxinshi Tablet in Improving Exercise Tolerance in Patients With Chronic Coronary Syndrome(Qi Deficiency and Blood Stasis Syndrome):A Randomized, Double-blind,Placebo-parallel-controlled,Multicenter Clinical Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Dongzhimen Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study adopted a randomized, double-blind, placebo-controlled, multicenter clinical design and compared the effects of Yangxinshi tablet and placebo on exercise tolerance in patients with chronic coronary syndrome (CCS).

Detailed description

The aim of the research is to find out if the addition of Yangxinshi tablets on the basis of conventional treatment can improve exercise tolerance of patients with chronic coronary syndrome (CCS), improve quality of life and mental health. A total of 120 qualified CCS patients were randomly divided into two groups. In addition to conventional treatment, the experimental group was given Yangxinshi tablets (3 tablets/time and 3 times/day), and the control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day). The treatment period was 24 weeks. The primary endpoints were metabolic equivalents (METs), and peak oxygen uptake measured by cardiopulmonary exercise testing after 24 weeks of treatment.

Conditions

• Chronic Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Yangxinshi tablet	The treatment group was given Yangxinshi tablets (3 tablets/time and 3 times/day). The treatment period was 24 weeks.
DRUG	Yangxinshi tablet simulants	The control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day).The treatment period was 24 weeks.

Timeline

• Start date: 2023-11-08
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2023-08-07
• Last updated: 2023-12-18

Locations

6 sites across 1 country: China