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Phase 4
Age: 30Years - 75Years
All Genders
ID06092736

Study of Compound Danshen Dropping Pills for Treating Microvascular Angina in Adults Aged 30 to 75 Randomized, Double-Blind, Placebo-Controlled Phase 4 Trial

Led by Qilu Hospital of Shandong University · Updated on 2023-10-23

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the effects of Compound Danshen Dropping Pills in patients with microvascular angina, a condition characterized by chest pain caused by abnormalities in the small heart arteries. This randomized, double-blind, placebo-controlled, multicenter clinical trial aims to evaluate how this traditional Chinese medicine impacts coronary blood flow reserve and angina symptoms compared to a placebo in affected patients aged 30 to 75. The study builds on evidence suggesting that Compound Danshen Dropping Pills may improve vascular function and relieve angina symptoms. Participants are randomly assigned to one of two groups one receiving Compound Danshen Dropping Pills and the other receiving a placebo. Both groups take 20 capsules orally three times a day after meals for six months. Follow-up visits occur every two months during the treatment period to monitor progress. The study measures the coronary flow reserve using ultrasound and tracks changes in angina attack frequency, exercise tolerance, and electrocardiogram changes during exercise. During the trial, participants undergo coronary artery imaging, electrocardiograms, and laboratory tests to assess heart function and safety. The main outcome is the change in coronary flow reserve after six months compared to baseline. Secondary outcomes include the number of angina attacks per week, the timing of angina during exercise, and the time to ischemic changes on the electrocardiogram. Safety is closely monitored through clinical evaluations and laboratory tests. Participants remain in the study for a total of six months with regular assessments to evaluate efficacy and side effects.

CONDITIONS

Brief Title

Microvascular Angina Intervention With Compound Danshen Dripping Pill (MAIDS)

Research Team

Y

Yun Zhang, PhD

X

Xiaoling Liu, PhD

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