Effect of MUSK Pill on the Patients With Chest Pain Due to Non Obstructive Coronary Artery Disease

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of MUSK Pill on the Patients With Chest Pain Due to Non Obstructive Coronary Artery Disease

Conditions
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Angina Pectoris, Non Obstructive Coronary Artery Disease, Coronary Heart Disease, X Syndrome, Angina

Intervention / Treatment
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* Drug: MUSK Pill
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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), and 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 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 diseases or conditions such as malignant tumor, severe anemia, severe renal artery stenosis, severe anxiety depression (HAMD-17) and suicide or maniac mental illness; Participated in other clinical studies within 30 days before the selection, or is currently participating in other clinical studies; Pregnant, lactating women and women and men with recent birth plans; Allergic constitution or allergy to known components of the study drug; The researchers judged that the patients who were not suitable for the study were not suitable.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 stratified block random grouping according to the center
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental group<br>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 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 | Drug: MUSK Pill<br>* On the basis of routine treatment, MUSK Pills were added to 4 capsules / day, 3 times per day until the end of follow-up.<br>|
| Placebo Comparator: Placebo group<br>The control group was given placebo 4 capsules / day, 3 times / day, until the end of follow-up. | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Seattle angina pectoris scale | Main evaluation indicators | 12 weeks ± 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of angina attacks per week | Secondary evaluation index | 12 weeks ± 1 week | 
| Changes in total dosage of sublingual nitroglycerin buccal tablets | Secondary evaluation index | 12 weeks ± 1 week | 
| Changes of Seattle Angina scale item score | Secondary evaluation index | 12 weeks ± 1 week | 
| Changes of angina pectoris classification in CCS | Secondary evaluation index | 12 weeks ± 1 week | 
| Incidence of major cardiovascular events (MACE) | Secondary evaluation index | 12 weeks ± 1 week | 
| the incremental cost-effectiveness ratio (ICER) was used as the evaluation index | Pharmacoeconomic evaluation | 12 weeks ± 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Musk pill, Shexiang Baoxin Pill, patients with chest pain due to non obstructive coronary artery disease