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Compound Danshen Dripping Pill for Diabetic Microvascular Angina

NCT ID: NCT06727890

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-06-30

Brief Summary

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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

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Conditions

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Diabetic Microvascular Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Compound Danshen Dripping Pill

Group Type EXPERIMENTAL

Danshen Dripping Pill

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, 10 pills once, three times a day

Interventions

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Danshen Dripping Pill

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

Intervention Type DRUG

Placebo

Placebo, 10 pills once, three times a day

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Pan-Pan Hao

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Site Status

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

Jinan, Shandong, China

Site Status

Countries

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China

Central Contacts

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Panpan Hao, MD, PhD

Role: CONTACT

Phone: 86-18560086593

Email: [email protected]

Facility Contacts

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Panpan Hao, MD, PhD

Role: primary

Bin Li, MD, PhD

Role: primary

Zhongwen Zhang, MD, PhD

Role: primary

Other Identifiers

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CDDP for CMVD

Identifier Type: -

Identifier Source: org_study_id