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

July 20, 2021 updated by: Shanghai Hutchison Pharmaceuticals Limited

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Shexiang Baoxin Pill on Coronary Microvascular Dysfunction

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

264

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • ShangHai, Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital Fudan University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;
  10. Researchers think that there are other factors that are not suitable to participate in the trial; If one of the exclusion criteria is met, it can be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
The control group was given placebo 4 capsules / day, 3 times / day, until the end of follow-up.
Drug: 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
Other Names:
  • Placebo
Experimental: 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
Drug: 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
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the difference of HRR between the experimental group and the placebo group was significant
Time Frame: At the end of treatment (8 weeks (± 1 week))
Definition of abnormal heart rate recovery: peak HR during exercise - HR one minute into recovery at the end of exercise is defined as abnormal heart rate recovery when HR one minute into recovery is less than 12 beats / min.
At the end of treatment (8 weeks (± 1 week))

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Hutchison Pharmaceuticals Limited

Investigators

  • Principal Investigator: HaiMing Shi, doctor, Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

July 4, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

August 2, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMPE202001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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