Actively Recruiting
The Efficacy and Safety of Qishenyiqi Dripping Pill in Patients With Coronary Microvascular Disease
Led by Qilu Hospital of Shandong University · Updated on 2024-11-21
162
Participants Needed
3
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effectiveness and safety of Qishenyiqi dripping pills for patients with coronary microvascular disease, a condition causing chest pain due to small vessel problems in the heart. This Phase 4 trial will follow patients for one year to assess how the treatment affects coronary blood flow and cardiovascular events in those with this disease. The trial is randomized and quadruple-blinded to carefully compare Qishenyiqi with a placebo. Participants will be randomly assigned to receive either Qishenyiqi dripping pills or a placebo, each taken as one bag three times daily for 12 months. The study includes a long-term follow-up period of one year to observe changes in coronary flow reserve and any adverse cardiovascular events. Treatments are administered orally and monitored throughout the study period. During the trial, participants will have their coronary flow reserve measured by three-dimensional echocardiography at the start and after 12 months to evaluate heart blood flow changes. Researchers will monitor safety and cardiovascular outcomes over the year, tracking chest pain episodes and other heart-related events. Participants can expect regular assessments and follow-up visits throughout the study duration.
CONDITIONS
Brief Title
Qishenyiqi Dripping Pill for Coronary Microvascular Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Repeated chest pain attacks with typical exertional or resting angina pectoris
- Coronary arteries normal or with less than 20% stenosis
- Evidence of ischemic ST segment depression during rest or exercise
- Coronary flow reserve of the anterior descending artery less than 2.0
- Participant or guardian agrees to join the study
- Age between 40 and 75 years
You will not qualify if you...
- Previous myocardial infarction, PCI, or coronary artery bypass graft surgery
- History of heart failure
- Severe arrhythmia
- Refractory hypertension or hypertension with left ventricular wall thickness over 12 mm
- Familial hypercholesterolemia
- Takayasu arteritis, Kawasaki disease, or coronary artery malformation
- Pregnant, nursing, or planning pregnancy within one year
- Liver or kidney dysfunction
- Allergy to contrast agents or traditional Chinese medicines
- Participation in other drug clinical trials within 3 months prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants take Qishenyiqi dripping pills or placebo, 1 bag three times a day for 12 months.
Visits occur periodically during the 12-month treatment period
Trial Site Locations
Total: 3 locations
1
Qianfoshan Hospital, Shandong University
Jinan, Shandong, China, 250012
Active, Not Recruiting
2
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
3
Jinan Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China, 250031
Actively Recruiting
Research Team
P
Panpan Hao, Dr.
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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