Treatment for Microvascular Angina with Danshen Pills

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of Compound Danshen Dropping Pills in treating patients with microvascular angina, a condition characterized by exertional chest pain due to abnormalities in small coronary blood vessels. The study is designed as a randomized, double-blind, placebo-controlled trial, enrolling patients who exhibit typical symptoms of exertional angina but have normal coronary arteries or minimal stenosis. Participants will be randomly assigned to receive either the experimental drug or a placebo, with outcomes measured through echocardiography and other assessments of coronary blood flow reserve. The goal is to determine if the Danshen pills can improve symptoms and vascular function in these patients.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. with typical symptoms of exertional angina;
2. coronary CTA or angiography with normal coronary artery or \<50% stenosis, or \<50% residual coronary stenosis after revascularization;
3. resting electrocardiogram or During exercise stress, it was found that the ST segment had an ischemic downward shift (the horizontal or downward slope after the J-point shift \> 0.1 mv, lasting 0.08 s);
4. Transthoracic ultrasound examination of blood in the anterior descending coronary artery before and after intravenous injection of adenosine Flow reserve check CFR\<2.5;
5. The patient himself agrees to participate in this study.

Exclusion criteria

1. Less than 30 years old or more than 75 years old;
2. Have a history of carotid endarterectomy or stent implantation, and have a history of stroke;
3. Myocarditis, pericardial disease, valvular disease, cardiomyopathy;
4. Difficult to control diabetes mellitus (fasting blood glucose\>7.0 mmol/L);
5. Uncontrolled hypertension (SBP\>150 mmHg and/or DBP\>90 mmHg);
6. Familial hypercholesterolemia;
7. Multiple Takayasu arteritis;
8. Those who are pregnant or lactating, or have fertility intention within one year, or have not taken effective contraceptive measures during the childbearing period;
9. Abnormal liver function (the level of serum GPT is 3.0 times higher than the upper limit of normal value) or abnormal renal function (the level of serum creatinine is more than 2 mg/dl);
10. Other respiratory, digestive, blood, infection, immunity, endocrine, neuropsychiatric, tumor diseases with clinical significance that may cause serious danger to patients;
11. Taking traditional Chinese medicine preparations of K channel opener, promoting blood circulation and removing blood stasis to improve microcirculation;
12. Allergies to intra arterial injection of contrast agents, blood and blood products;
13. Patients who are participating in other clinical studies.

Where it's running

• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Yun Zhang, PhD — Qilu Hospital of Shandong University
• Study coordinator: Yun Zhang, PhD
• Email: zhangyun@sdu.edu.cn
• Phone: +86-18560086626

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.