Compound Danshen Dripping Pill for Diabetic Microvascular Angina

NCT06727890 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: CDDP for CMVD
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetic Microvascular Angina

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Compound Danshen Dripping Pill

EXPERIMENTAL

Drug: Danshen Dripping Pill

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Danshen Dripping Pill DRUG

Danshen Dripping Pill, 10 pills once, three times a day

Compound Danshen Dripping Pill

Placebo DRUG

Placebo, 10 pills once, three times a day

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (3)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250013, China

Location

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

Jinan, Shandong, 250031, China

Location

MeSH Terms

Interventions

danshen dripping pill

Central Study Contacts

Panpan Hao, MD, PhD

CONTACT

86-18560086593; panda.how@sdu.edu.cn

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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

CN (3)