Qishenyiqi Dripping Pill for Coronary Microvascular Disease (CMVD)

November 20, 2024 updated by: Pan-Pan Hao, Qilu Hospital of Shandong University

The Efficacy and Safety of Qishenyiqi Dripping Pill in Patients With Coronary Microvascular Disease

To investigate the efficacy and safety of Qishenyiqi in patients with microvascular angina pectoris. Long-term follow-up of 1 year will be performed to evaluate the effect of Qishenyiqi on coronary flow reserve and adverse cardiovascular events in patients with coronary microvascular disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

162

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 Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • Jinan, Shandong, China, 250012
        • Active, not recruiting
        • Qianfoshan Hospital, Shandong University
      • Jinan, Shandong, China, 250031
        • Recruiting
        • Jinan Central Hospital Affiliated to Shandong First Medical University
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
  • Coronary normal or stenosis < 20%;
  • Ischemic depression in ST segment during resting or exercise;
  • Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0;
  • Subjects or their guardians agreed to participate in this study.

Exclusion Criteria:

  • Previous myocardial infarction or PCI or CABG treatment;
  • A history of heart failure;
  • Severe arrhythmia;
  • Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm;
  • Familial hypercholesterolemia;
  • Takayasu arteritis, Kawasaki disease or coronary artery malformation;
  • Pregnant or nursing, or having the intention to give birth within one year;
  • Hepatic or renal dysfunction;
  • Allergic to contrast agents or traditional Chinese medicines;
  • Patients who participated in clinical research of other drugs within 3 months before being selected.

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
Drug: Placebo 1 bag, three times a day
Placebo, 1 bag once, three times a day, 12 months
Experimental: Qishenyiqi Dripping Pill
Drug: Qishenyiqi dripping pills 1 bag, three times a day
Qishenyiqi dripping pills, 1 bag once, three times a day, 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Qilu Hospital of Shandong University

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)

November 8, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Estimated)

November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Qishenyiqi for CMVD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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