Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With SCAD

Phase 4

• Conditions: Stable Coronary Heart Disease
• Interventions: Drug: Zhenyuan capsule

• Registration Number: NCT04421287
• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Brief Summary

A randomized, double-blind, placebo trial was adopted, and cardiopulmonary exercise load test (CPET) was used to detect peak oxygen uptake (PeakVO2) and exercise metabolic equivalent (METs) to confirm the clinical effect of Zhenyuan capsule on improving cardiopulmonary endurance in patients with coronary heart disease of qi deficiency and blood stasis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-05-06
• Study Start: 2020-06-01
• Study First Submitted QC: 2020-06-04
• Last Update Submitted: 2020-06-04
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09
• Primary Completion: 2021-07-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Results of coronary angiography or spiral CT:Patients with coronary artery stenosis ≥ 50%, or with a clear history of myocardial infarction, or stable condition more than one month after ACS treatment (percutaneous coronary intervention therapy, PCI, coronary artery bypass graft, CABG)；
• LVEF≥40%；
• Angina grade Ⅰ-Ⅱ (CCS grade);
• The syndrome differentiation of traditional Chinese medicine is the syndrome of qi deficiency and blood stasis；
• 18 years old ≤ age ≤ 75 years old；
• In accordance with the risk stratification of cardiac rehabilitation in patients with coronary heart disease, the patients with moderate and low risk can carry out cardiopulmonary rehabilitation by exercise；
• Those who sign the informed consent form.

Exclusion Criteria

• Patients with acute myocardial infarction or unstable angina pectoris, or within one month after PCI or CABG;
• Patients with absolute and relative contraindications in accordance with cardiopulmonary exercise test;
• Patients who took Zhenyuan capsule in the past 1 month or participated in other clinical trials in the past 1 month；
• Renal insufficiency, serum creatinine > 2.5mg / dl in male and > 2.0mg/dl in female；
• Patients with obvious liver disease or both ALT and AST were 3 times higher than the normal upper limit；
• New York heart function (NYHA) grade IV, or patients with recurrent malignant arrhythmias;
• Complicated with chronic obstructive pulmonary disease or even respiratory failure, or complicated with pulmonary infection;
• Diabetic patients with random blood glucose ≥ 13.7mmol/L or glycosylated hemoglobin ≥ 9.5%;
• Pregnant or preparing pregnant women, lactating women;
• Patients with acute cerebrovascular diseases; malignant tumors or patients with life expectancy of less than 1 year; patients with severe hematopoietic diseases; patients with severe mental illness;
• For those who are allergic to the known ingredients of the drug.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zhenyuan capsule placebo	Zhenyuan capsule	-
Zhenyuan capsule	Zhenyuan capsule	-

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary function index change	Change from Baseline VO2 peak at 12 weeks / 16 weeks after drug treatment;	Peak Oxygen Uptake（Peak VO2）；Heart rate、Stroke volume and arteriovenous oxygen difference will be combined to report VO2 peak in mL/kg/min(milliliters of oxygen per kilogram of body weight per minute )；

Trial Locations

Locations (1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, China