Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With SCAD (NCT04421287) | Clinical Trial Compass
UnknownPhase 4
Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With SCAD
China100 participantsStarted 2020-06-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 â… -â…¡ (CCS grade);
* The syndrome differentiation of traditional Chinese medicine is the syndrome of qi deficiency and blood stasisï¼›
* 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 exerciseï¼›
* 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 monthï¼›
* Renal insufficiency, serum creatinine \> 2.5mg / dl in male and \> 2.0mg/dl in femaleï¼›
* Patients with obvious liver disease or both ALT and AST were 3 times higher than the normal upper limitï¼›
* New York heart function (NYHA) grade IV, or patients with recurrent malignant arrhythmias;
* Complicated with chronic obstructive pulmonary disease or even respiratory failure, or com…
What they're measuring
1
Cardiopulmonary function index change
Timeframe: Change from Baseline VO2 peak at 12 weeks / 16 weeks after drug treatment;
Trial details
NCT IDNCT04421287
SponsorXiyuan Hospital of China Academy of Chinese Medical Sciences