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

NCT04421287 | Unknown Phase 4

• 1 other identifier: 2020XLA018-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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;

Study Arms (2)

Zhenyuan capsule

EXPERIMENTAL

Drug: Zhenyuan capsule

Zhenyuan capsule placebo

PLACEBO COMPARATOR

Drug: Zhenyuan capsule

Interventions

Zhenyuan capsule DRUG

0.25g/ tablets, 2 tablets / TID, for 12 weeks

Zhenyuan capsule; Zhenyuan capsule placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, 100091, China

Location

Study Officials

• Long C Wang, doctorate

  Xiyaun Hospital of China Academy of Chinese Medical Sciences

  STUDY CHAIR

Central Study Contacts

NA HUAN, Master

CONTACT

0086; HUANNA0323@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double mind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: June 9, 2020
• Study Start: June 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 9, 2020

Record last verified: 2020-04

Locations

CN (1)