Compound Danshen Dripping Pill for Diabetic Microvascular Angina

Last updated: December 6, 2024
Sponsor: Qilu Hospital of Shandong University
Overall Status: Active - Not Recruiting

Phase

4

Condition

Angina

Circulation Disorders

Cardiac Ischemia

Treatment

Placebo

Danshen Dripping Pill

Clinical Study ID

NCT06727890
CDDP for CMVD
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 162
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
January 01, 2025
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong 250013
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Site Not Available

  • The First Affiliated Hospital of Shandong First Medical University/Shandong Province Qianfoshan Hospital

    Jinan, Shandong 250031
    China

    Site Not Available

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