NCT04984954

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

2.9 years

First QC Date

July 4, 2021

Last Update Submit

July 20, 2021

Conditions

Angina PectorisCoronary Heart DiseaseX Syndrome, AnginaNon Obstructive Coronary Artery Disease

Keywords

Shexiang Baoxin PillMusk pillPatients with coronary microvascular dysfunction

Outcome Measures

Primary Outcomes (1)

  • the difference of HRR between the experimental group and the placebo group was significant

    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))

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Drug: MUSK pill

Interventions

MUSK pillDRUG

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

Also known as: Placebo
Experimental groupPlacebo group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Coronary heart disease complicated with hypertrophic cardiomyopathy;
  • There was a history of AMI, PCI and CABG, and myocardial bridge was found by angiography or CTA;
  • Patients with severe medical diseases (liver, kidney, hematopoietic system and other serious primary diseases, etc.);
  • Mental disorders and mental diseases;
  • Patients with pulmonary failure and NYHA heart function grade III-IV, unable to carry out exercise test;
  • Contraindications of Shexiang Baoxin Pill: forbidden for pregnant women;
  • Those who have known history of allergy to Shexiang Baoxin Pills;
  • 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;
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Angina PectorisCoronary DiseaseMicrovascular Angina

Interventions

musk

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • HaiMing Shi, doctor

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HaiMing Shi, doctor

CONTACT

+861390182485913901824859@163.com

Ying Shan, doctor

CONTACT

+8613402021699shanyingli@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 stratified block random grouping according to the center
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2021

First Posted

August 2, 2021

Study Start

January 28, 2021

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

August 2, 2021

Record last verified: 2021-07

Locations

CN(1)