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

Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With Stable Coronary Heart Disease With Qi Deficiency and Blood Stasis

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.

Study Overview

• Status: Unknown
• Conditions: Stable Coronary Heart Disease
• Intervention / Treatment: Drug: Zhenyuan capsule

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100091
    • Xiyuan Hospital of China Academy of Chinese Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Zhenyuan capsule	Drug: Zhenyuan capsule; 0.25g/ tablets, 2 tablets / TID, for 12 weeks
PLACEBO_COMPARATOR: Zhenyuan capsule placebo	Drug: Zhenyuan capsule; 0.25g/ tablets, 2 tablets / TID, for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiopulmonary function index change	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 )；	Change from Baseline VO2 peak at 12 weeks / 16 weeks after drug treatment;

Collaborators and Investigators

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Investigators: Study Chair: Long C Wang, doctorate, Xiyaun Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (ACTUAL): June 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2020XLA018-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No