Qishenyiqi Dripping Pill for Coronary Microvascular Disease
Phase 4
Recruiting
- Conditions
- Coronary Microvascular Disease
- Interventions
- Drug: Qishenyiqi dripping pills 1 bag, three times a dayDrug: Placebo 1 bag, three times a day
- Registration Number
- NCT06699420
- Lead Sponsor
- Qilu Hospital of Shandong University
- Brief Summary
To investigate the efficacy and safety of Qishenyiqi in patients with microvascular angina pectoris. Long-term follow-up of 1 year will be performed to evaluate the effect of Qishenyiqi on coronary flow reserve and adverse cardiovascular events in patients with coronary microvascular disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 162
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Qishenyiqi Dripping Pill Qishenyiqi dripping pills 1 bag, three times a day - Placebo Placebo 1 bag, three times a day -
- Primary Outcome Measures
Name Time Method Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up 1 year
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Qishenyiqi's effects on coronary microvascular endothelial function and coronary flow reserve?
How does Qishenyiqi compare to standard-of-care therapies like beta-blockers in improving angina symptoms and microvascular function in CMD patients?
Which biomarkers (e.g., endothelial progenitor cells, inflammatory markers) predict response to Qishenyiqi in coronary microvascular disease?
What are the long-term safety profiles and adverse event management strategies for Qishenyiqi in CMD patients compared to placebo?
How does Qishenyiqi's pharmacological profile synergize with ACE inhibitors or antiplatelet agents in managing coronary microvascular dysfunction?
Trial Locations
- Locations (3)
Qianfoshan Hospital, Shandong University
🇨🇳Jinan, Shandong, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Jinan Central Hospital Affiliated to Shandong First Medical University
🇨🇳Jinan, Shandong, China