Compound Danshen Dripping Pill for Diabetic Microvascular Angina (MVA)

December 6, 2024 updated by: Pan-Pan Hao, Qilu Hospital of Shandong University

The Efficacy and Safety of Compound Danshen Dripping Pill in Patients With Diabetic Microvascular Angina

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

Study Overview

Status

Not yet 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
        • Qilu Hospital of Shandong University
        • Principal Investigator:
          • Panpan Hao, MD, PhD
        • Contact:
      • Jinan, Shandong, China, 250013
        • Central Hospital Affiliated to Shandong First Medical University
        • Principal Investigator:
          • Bin Li, MD, PhD
        • Contact:
      • Jinan, Shandong, China, 250031
        • The First Affiliated Hospital of Shandong First Medical University/Shandong Province Qianfoshan Hospital
        • Contact:
        • Principal Investigator:
          • Zhongwen Zhang, MD, PhD

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:

History of type 2 diabetes ≧5 years; Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks; Coronary normal or stenosis <50%; Ischemic depression in ST segment during resting or exercise; Coronary flow reserve (CFR) of the anterior descending coronary artery < 2.0, or CFR ≧2.0 but acetylcholine activation test is positive; Subjects or their guardians agreed to participate in this study.

Exclusion Criteria:

Previous myocardial infarction or PCI or CABG treatment; 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
Placebo, 10 pills once, three times a day
Experimental: Compound Danshen Dripping Pill
Drug: Danshen Dripping Pill
Danshen Dripping Pill, 10 pills once, three times a day

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: From baseline to the end of 12-month treatment
From baseline to the end of 12-month treatment

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 (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Estimated)

December 11, 2024

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 6, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDDP for CMVD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It might damage the privacy of patients.

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.

Clinical Trials on Diabetic Microvascular Angina

Clinical Trials on Danshen Dripping Pill

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe