Actively Recruiting

Phase 4
Age: 30Years - 75Years
All Genders
NCT06092736

Microvascular Angina Intervention With Compound Danshen Dripping Pill (MAIDS)

Led by Qilu Hospital of Shandong University · Updated on 2023-10-23

100

Participants Needed

1

Research Sites

497 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Coronary microvascular disease (MVD) refers to exertional angina or myocardial ischemia caused by abnormal structure and/or function of precoronary arterioles and arterioles under the action of various pathogenic factors. The symptoms of patients with coronary microvascular disease are mainly exertion-related chest pain episodes. The basic and clinical researches of the traditional Chinese medicine compound Danshen dropping pills have found that it can improve vascular endothelial function and relieve angina pectoris, and it is widely used in clinical practice. This is a randomized, double-blind, placebo-controlled, multicenter clinical study of Compound Danshen Dropping Pills and blank control in patients with microvascular angina pectoris. The experimental drug and control drug of this clinical trial were selected according to the ratio of 1:1 patients were enrolled in the pre-experiment. After the selected patients signed the informed consent, they were divided into a compound Danshen dripping pill treatment group and a placebo group according to a random, double-blind, placebo-controlled method. Dosage of Compound Danshen Dropping Pills or placebo: 20 capsules each time, 3 times a day, for a total of 6 months. Follow-up was performed every 2 months for a total of 6 months. Primary study endpoints is the difference of the left anterior descending coronary flow reserve (CFR) measured by ultrasound between the two groups compared with the baseline. Secondary study endpoint include the Number of angina attacks per week, the time of angina pectoris and the time of ischemic ST segment depression in exercise test.

CONDITIONS

Official Title

Microvascular Angina Intervention With Compound Danshen Dripping Pill (MAIDS)

Who Can Participate

Age: 30Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have typical symptoms of chest pain during exertion
  • Coronary CT angiography or angiography showing normal arteries or less than 50% stenosis, or less than 50% residual stenosis after revascularization
  • Resting or exercise electrocardiogram showing ischemic ST segment depression greater than 0.1 mv lasting at least 0.08 seconds
  • Transthoracic ultrasound showing left anterior descending coronary artery flow reserve less than 2.5 after adenosine injection
  • Agree to participate in the study
Not Eligible

You will not qualify if you...

  • Younger than 30 years or older than 75 years
  • History of carotid endarterectomy, stent implantation, or stroke
  • Diagnosis of myocarditis, pericardial disease, valvular disease, or cardiomyopathy
  • Poorly controlled diabetes with fasting blood glucose above 7.0 mmol/L
  • Uncontrolled hypertension with systolic blood pressure above 150 mmHg or diastolic above 90 mmHg
  • Familial hypercholesterolemia
  • Takayasu arteritis
  • Pregnant, breastfeeding, planning pregnancy within one year, or not using effective contraception if of childbearing age
  • Abnormal liver function with serum GPT over three times the upper limit or abnormal kidney function with serum creatinine over 2 mg/dl
  • Other serious respiratory, digestive, blood, infectious, immune, endocrine, neuropsychiatric, or tumor diseases
  • Use of K channel openers or traditional Chinese medicines promoting blood circulation to improve microcirculation
  • Allergy to contrast agents, blood, or blood products
  • Participation in other clinical trials

AI-Screening

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Trial Site Locations

Total: 1 location

1

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250012

Actively Recruiting

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Research Team

Y

Yun Zhang, PhD

CONTACT

X

Xiaoling Liu, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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