NCT06224582

Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCI

Efficacy and Safety of Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCI: A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multi-center, double-blind, randomized, placebo-controlled trial is conducted to evaluate the efficacy and safety of Yinxingmihuan oral solution in the treatment of chest pain after percutaneous coronary intervention (PCI) in patients with stable angina. Patients should undergo at least 1-week standardized medical treatment phase before randomization. The primary end point is the 12-week angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ) subscales. The main secondary endpoint is the improvement of anxiety assessed by Hamilton Anxiety Scale (HAMA) to evaluate its effectiveness for chest pain caused by psychological factors.

Conditions

• Chronic Stable Angina

Interventions

Type	Name	Description
DRUG	Yinxingmihuan oral solution	Yinxingmihuan oral solution is made of Ginkgo leaf extract and armillariella mellea powders.
DRUG	Placebo	The placebo oral solution is in the same appearance, color, smell and taste as the experimental Yinxingmihuan oral solution.

Timeline

• Start date: 2020-12-30
• Primary completion: 2023-12-25
• Completion: 2023-12-25
• First posted: 2024-01-25
• Last updated: 2024-01-25

Locations

1 site across 1 country: China