Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With SCAD
June 4, 2020 updated by: Xiyuan Hospital of China Academy of Chinese Medical Sciences
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Beijing, China, 100091
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Zhenyuan capsule
|
0.25g/ tablets, 2 tablets / TID, for 12 weeks
|
|
PLACEBO_COMPARATOR: Zhenyuan capsule placebo
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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
Time Frame: 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 )；
|
Change from Baseline VO2 peak at 12 weeks / 16 weeks after drug treatment;
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Long C Wang, doctorate, Xiyaun Hospital of China Academy of Chinese Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
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