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December 1, 2023International Journal of General MedicineOpen Access

Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Qi Deficiency with Blood Stasis): Study Protocol for a Randomized, Placebo-Controlled, Double-Blind and Multi-Centre Phase II Clinical Trial

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Key result

This is a study protocol for a randomized, placebo-controlled trial of 228 patients to evaluate Qishen Yiqi dropping pills for CHD complicating chronic HFrEF; no results are available.

Why the study?

Heart failure is a common complication of coronary heart disease, and this study aims to evaluate the clinical efficacy, safety, and optimal effective dose of Qishen Yiqi dropping pills in patients with CHD complicating HFrEF.

Population

228 individuals with CHD complicating HFrEF from 16 hospitals in China

Comparison

Low-dose QSYQ vs high-dose QSYQ vs placebo

Design

Randomized, double-blind, placebo-controlled, multicenter phase II clinical trial

Follow-up

12 weeks

Authors

XHXingling HeYJYanhui JiangSLSijing Li

Discussion

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Overview

Study Design

Type

RCT (n=228)

Blinding

Double-blind

Randomization

1:1:1

Multicenter

Yes

PICO

P
Population
228 individuals with coronary heart disease complicating chronic heart failure with reduced ejection fraction, planned for a 12-week treatment period.
I
Intervention / Comparator
Qishen Yiqi dropping pills (QSYQ) vs placebo (low-dose, high-dose)
O
Primary Outcome
6-Minute Walk Test (6MWT) at Week 12

Cite This Study

He et al. (2023) conducted an RCT in Coronary heart disease complicating chronic heart failure with reduced ejection fraction (HFrEF) (n=228). Qishen Yiqi dropping pills (QSYQ) vs. placebo was evaluated on 6-Minute Walk Test (6MWT) at Week 12. This is a study protocol for a randomized, placebo-controlled trial of 228 patients to evaluate Qishen Yiqi dropping pills for CHD complicating chronic HFrEF; no results are available.

synapsesocial.com/papers/6a97ecb5d08ffd74dfc636cdhttps://doi.org/10.2147/ijgm.s436999
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Also Consider

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  1. 1Efficacy and safety of Qishen Yiqi dripping pills as a complementary treatment for Heart Failure2021 · 3 citations
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  3. 3Effects of Qishen Yiqi dropping pills plus conventional Western medicine on cardiac function and quality of life of patients with chronic heart failure2026
  4. 4A multi-center, randomized, double-blind, placebo-parallel controlled trial for the efficacy and safety of shenfuqiangxin pills in the treatment of chronic heart failure (Heart-Kidney yang deficiency syndrome)2020 · 24 citations
  5. 5Improvement of exercise tolerance and physical function in elderly patients with heart failure with preserved ejection fraction by QiShen YiQi dripping pills2026 · 1 citations