Evaluate the Efficacy and Safety of MUSK Pill on Coronary Microvascular Dysfunction

NCT ID: NCT04984954

Last Updated: 2021-08-02

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-28

Study Completion Date

2024-06-30

Brief Summary

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Objective to evaluate the effect of Shexiang Baoxin Pill on myocardial ischemia in patients with coronary microvascular dysfunction (non obstructive coronary heart disease) through a randomized, double-blind, placebo-controlled clinical multicenter study.At the same time, the effects of exercise tolerance and quality of life were also observed.

Detailed Description

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Conditions

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

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

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

Group Type EXPERIMENTAL

MUSK pill

Intervention Type DRUG

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

Placebo group

The control group was given placebo 4 capsules / day, 3 times / day, until the end of follow-up.

Group Type PLACEBO_COMPARATOR

MUSK pill

Intervention Type DRUG

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

Interventions

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MUSK pill

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

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

1. Patients aged 18-80, male or female;
2. Selective coronary angiography or coronary CTA showed that the diameter of coronary artery ≥ 2.5mm, the degree of stenosis \< 50%, without myocardial bridge;
3. They were able to perform treadmill exercise, and the treadmill test (EET) was positive;
4. Angina pectoris was found;
5. Patients are willing to follow up and sign informed consent; All the above criteria should be met.

Exclusion Criteria

1. Coronary heart disease complicated with hypertrophic cardiomyopathy;
2. There was a history of AMI, PCI and CABG, and myocardial bridge was found by angiography or CTA;
3. Patients with severe medical diseases (liver, kidney, hematopoietic system and other serious primary diseases, etc.);
4. Mental disorders and mental diseases;
5. Patients with pulmonary failure and NYHA heart function grade III-IV, unable to carry out exercise test;
6. Contraindications of Shexiang Baoxin Pill: forbidden for pregnant women;
7. Those who have known history of allergy to Shexiang Baoxin Pills;
8. Recently, the patient has taken Shexiang Baoxin Pill and other anti ischemic traditional Chinese medicine regularly, or it contains borneol, toad venom and other ingredients in Shexiang Baoxin Pill;
9. Combined with frequent ventricular premature beats, ventricular tachycardia, atrial fibrillation, sinoatrial block, atrioventricular pathway block, left bundle branch block and right bundle branch block, which may affect the judgment of exercise ECG results;
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Hutchison Pharmaceuticals Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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HaiMing Shi, doctor

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

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Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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HaiMing Shi, doctor

Role: CONTACT

+8613901824859

Ying Shan, doctor

Role: CONTACT

+8613402021699

Facility Contacts

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Haiming Shi, doctor

Role: primary

+8613801731588

Ying Shan, doctor

Role: backup

+8613402021699

Other Identifiers

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HMPE202001

Identifier Type: -

Identifier Source: org_study_id

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