Efficacy and Safety of Shexiang Baoxin Pill in Patients With Ischemia With Non-Obstructive Corona… (NCT04897126) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Shexiang Baoxin Pill in Patients With Ischemia With Non-Obstructive Coronary Artery
China240 participantsStarted 2021-05-11
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients were treated with the trial drug or placebo in a 1:1 ratio. The control group was treated with placebo 4 pills / day, 3 times / day on the basis of conventional treatment until the end of follow-up, while the experimental group was treated with MUSK Pill 4 pills / day, 3 times / day on the basis of conventional treatment until the end of follow-up.
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:
* The age was 18-75 years old, and the gender was not limited;
* The clinical diagnosis of angina pectoris or angina pectoris equivalent symptoms (attack at least twice a week), Within 1 year, coronary CTA or coronary angiography examination of coronary artery normal or lesions \< 50%;
* Willing to follow up and sign informed consent.
Exclusion Criteria:
* Patients were selected and had no angina pectoris without medication
* History of vascular reconstruction within 6 months, CABG or PCI;
* Preparation for CABG or PCI during the trial period
* The maximum lesions of major branches of major vessels were ≥ 50% in CTA or angiographic examination;
* Severe cardiovascular and pulmonary vascular diseases: stubborn heart failure or cardiogenic shock, hypertrophic obstructive cardiomyopathy, severe aortic stenosis, incomplete closure, aortic dissection, pulmonary embolism;
* There were three months of acute myocardial infarction;
* Severe respiratory disease, COPD or active pulmonary infection;
* Although the patients with poor blood pressure control were treated with hypertension, the hypertension was not controlled and / or systolic pressure ≥ 180mmhg and diastolic pressure ≥ 110mmhg before the end of screening period;
* Severe liver and kidney diseases, such as liver and kidney dysfunction (alt, AST ≥ 1.5 times of the upper limit of normal value, Cr \> 1.5 times of normal value), active liver disease, cirrhosis or uremia patients;
* Any other serious diseas…