Compound Danshen Dripping Pill for Diabetic Microvascular Angina

Phase 4

Not yet recruiting

• Conditions: Diabetic Microvascular Angina
• Interventions: Drug: Danshen Dripping Pill; Drug: Placebo

• Registration Number: NCT06727890
• Lead Sponsor: Qilu Hospital of Shandong University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Study Start: 2025-01-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 162

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compound Danshen Dripping Pill	Danshen Dripping Pill	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up	From baseline to the end of 12-month treatment

Trial Locations

Locations (3)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

Central Hospital Affiliated to Shandong First Medical University; 🇨🇳 Jinan, Shandong, China

The First Affiliated Hospital of Shandong First Medical University/Shandong Province Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China