NCT04661709

Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris

Efficacy and Safety of Chinese Herbal Medicine Wen Xin Granules for the Treatment of Unstable Angina Pectoris With Yang Deficiency and Blood Stasis Syndrome: Study Protocol for a Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 502 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomized placebo-controlled trial which aims to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina pectoris.

Detailed description

Coronary heart disease has remained the leading cause of death worldwide over the past decades. Unstable angina is a clinical syndrome intermediate in severity between stable angina and acute myocardial infarction with high morbidity and mortality. Standard drug therapy and invasive revascularization are effective in decreasing progression to infarction, reducing symptoms and multiple hospitalizations, in most cases without a decrease in the long-term mortality rate. However, there are still many patients with persistence or recurrence of angina despite standard medical therapy and/or revascularization. Wen Xin granule, as a Chinese herbal medicine has shown great effect in patients with unstable angina in our clinical. However, there is still insufficient evidence on his specific efficacy and safety. Therefor, we'd like to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina through this multi-center, double-blind, randomized placebo-controlled trial.

Conditions

• Coronary Heart Disease
• Unstable Angina
• Chinese Herbal Medicine

Interventions

Type	Name	Description
DRUG	Wen Xin granule	one dose daily, two times per day.
DRUG	Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet	one tablet daily. (for patients who can't use aspirin)
DRUG	Atorvastatin Calcium	20 mg tablet, one tablet each night.
DRUG	Isosorbide Mononitrate Tab 20 MG	one tablet， twice daily.
DRUG	Metoprolol Tartrate Tab 25 MG	12.5 mg or 25 mg, two times daily.
DRUG	Aspirin Enteric-coated Tablets	100mg tablet, one tablet daily.
DRUG	WXG placebo	one dose daily, two times per day.
DRUG	Trimetazidine Dihydrochloride Tablets	20 mg tablet, one tablet three times daily.
DRUG	glyceryl trinitrate	be taken when angina pectoris attacks.

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-03-01
• Completion: 2023-06-01
• First posted: 2020-12-10
• Last updated: 2021-01-25