NCT04983043

Efficacy and Safety of QiShen YiQi Dripping Pills in Chronic Heart Failure

A Multi-center, Randomized, Double-blind, Placebo-parallel Controlled, Standardise-loaded Ⅱ Clinical Trial of Efficacy and Safety of QiShen YiQi Dripping Pills in Chronic Heart Failure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Tasly Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety and the best effective dose of QiShen YiQi Dripping Pills in the treatment of chronic heart failure with decreased ejection fraction of CHD (Qi deficiency and blood stasis syndrome).

Detailed description

QiShen YiQi Dripping Pills are oral, compound traditional chinese medicine prepatations. This study will evaluate the efficacy and safety and the best effective dose of QiShen YiQi Dripping Pills in the treatment of chronic heart failure with decreased ejection fraction of CHD (Qi deficiency and blood stasis syndrome).

Conditions

• Chronic Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
DRUG	Low dose QiShen YiQi Dripping Pills 3 bags	Low dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 2 bags(0.52g dripping pills per bag) and QiShen YiQi Dripping Pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
DRUG	High dose QiShen YiQi Dripping Pills 3 bags	High dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks
DRUG	QiShen YiQi Dripping Pills placebo 3 bags	QiShen YiQi Dripping Pills placebo contain QiShen YiQi Dripping Pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks

Timeline

• Start date: 2021-06-10
• Primary completion: 2024-11-27
• Completion: 2024-11-27
• First posted: 2021-07-30
• Last updated: 2025-01-10

Locations

23 sites across 1 country: China