Qishenyiqi Dripping Pill for treating Coronary Microvascular Disease
The Efficacy and Safety of Qishenyiqi Dripping Pill in Patients With Coronary Microvascular Disease
This study is testing if Qishenyiqi dripping pills can help people with microvascular angina feel better and improve their heart health compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 3 sites (Jinan, Shandong and 2 other locations) |
| Trial ID | NCT06699420 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of Qishenyiqi dripping pills in patients suffering from microvascular angina pectoris. Participants will receive either the Qishenyiqi treatment or a placebo, with a regimen of one bag three times a day. The study includes a long-term follow-up period of one year to assess the impact of the treatment on coronary flow reserve and the occurrence of adverse cardiovascular events. The trial aims to provide insights into the potential benefits of this traditional Chinese medicine for coronary microvascular disease.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals experiencing repeated chest pain attacks with typical exertional or resting angina, and who have a coronary flow reserve of less than 2.0.
Not a fit: Patients with a history of myocardial infarction, severe arrhythmias, or significant coronary artery disease are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with coronary microvascular disease, potentially improving their quality of life and reducing cardiovascular events.
How similar studies have performed: While the use of traditional Chinese medicine in cardiovascular conditions is explored, this specific approach with Qishenyiqi has not been widely tested in similar studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks; * Coronary normal or stenosis \< 20%; * Ischemic depression in ST segment during resting or exercise; * Blood flow reserve (CFR) of the anterior descending coronary artery \< 2.0; * Subjects or their guardians agreed to participate in this study. Exclusion Criteria: * Previous myocardial infarction or PCI or CABG treatment; * A history of heart failure; * 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.
Where this trial is running
Jinan, Shandong and 2 other locations
- Qianfoshan Hospital, Shandong University — Jinan, Shandong, China (Active_not_recruiting)
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
- Jinan Central Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Panpan Hao, Dr.
- Email: panda.how@sdu.edu.cn
- Phone: 8618560086593
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.