Treatment for Microvascular Angina with Danshen Pills
Microvascular Angina Intervention With Compound Danshen Dripping Pill (MAIDS)
This study is testing if Danshen pills can help people with microvascular angina feel better by improving their chest pain and blood flow.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06092736 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 30 to 75 who experience exertional angina and have normal coronary arteries or minimal stenosis.
Not a fit: Patients with significant coronary artery disease, uncontrolled diabetes, or other serious cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate chest pain and improve quality of life for patients suffering from microvascular angina.
How similar studies have performed: While the use of traditional Chinese medicine for cardiovascular conditions is explored, this specific approach with Compound Danshen Dropping Pills is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jinan, Shandong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.