Efficacy and Safety of Shexiang Baoxin Pill in Patients With Ischemia With Non-Obstructive Coronary Artery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-11

Study Completion Date

2023-10-25

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.

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Detailed Description

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Conditions

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Ischemia With Non-Obstructive Coronary Artery Angina Pectoris Coronary Heart Disease X Syndrome, Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 stratified block random grouping according to the center

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental group

The experimental group was treated with Shexiang Baoxin pill（MUSKARDIA） (4 pills / day, 3 times / day) on the basis of conventional treatment until the end of follow-up

Group Type ACTIVE_COMPARATOR

Shexiang Baoxin pill（MUSKARDIA）

Intervention Type RADIATION

On the basis of routine treatment, MUSK Pills were added to 4 capsules / day, 3 times per day until the end of follow-up.

Placebo group

The control group was given placebo（ 4 capsules / day, 3 times / day）on the basis of conventional treatment until the end of follow-up.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type RADIATION

On the basis of routine treatment, Placebo were added to 4 capsules / day, 3 times per day until the end of follow-up.

Interventions

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Shexiang Baoxin pill（MUSKARDIA）

On the basis of routine treatment, MUSK Pills were added to 4 capsules / day, 3 times per day until the end of follow-up.

Intervention Type RADIATION

Placebo

On the basis of routine treatment, Placebo were added to 4 capsules / day, 3 times per day until the end of follow-up.

Intervention Type RADIATION

Other Intervention Names

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routine treatment routine treatment

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), 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 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.

(Note: patients need to stop using other cardiovascular traditional Chinese patent medicines and simple preparations or traditional Chinese medicine for 7 days before enrollment.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No