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May 22, 2020MedicineOpen Access

A 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)

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Key result

New trial protocol tests Shenfu Qiangxin Pills versus placebo on NT-proBNP in chronic heart failure.

  • n=352

Why the study?

There is a lack of high-quality trials assessing the efficacy and safety of Shenfu Qiangxin Pills for treating chronic heart failure with heart-kidney Yang deficiency syndrome.

Does Shenfu Qiangxin Pills reduce plasma NT-proBNP levels in patients with chronic heart failure (heart-kidney Yang deficiency syndrome)?

Population

352 patients with chronic heart failure (heart-kidney Yang deficiency syndrome) from 22 hospitals in China

Comparison

Shenfu Qiangxin Pills plus standardized western medicine vs placebo plus standardized western medicine

Design

Multi-center randomized double-blind placebo-controlled parallel-group trial

Follow-up

12 weeks

Authors

LGLijun GuoHYHui YuanDZDawu Zhang

Discussion

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Member takes

Overview

Shenfu Qiangxin Pills lack proven benefit in heart failure; this RCT will test NT-proBNP reduction and safety.

Study Design

Type

RCT (n=352)

Blinding

double-blind

Randomization

parallel-group

Multicenter

Yes

Structured PICO

Does Shenfu Qiangxin Pills reduce plasma NT-proBNP levels in patients with chronic heart failure (heart-kidney Yang deficiency syndrome)?

P
Population
352 patients with chronic heart failure (heart-kidney Yang deficiency syndrome) to be randomized to Shenfu Qiangxin Pills or placebo for 12 weeks.
I
Intervention
Shenfu Qiangxin Pills (SFQX) added to standardized western medicine for 12 weeks
C
Comparator
Placebo added to standardized western medicine for 12 weeks
O
Outcome
Plasma N-terminal pro-B-type natriuretic peptide levelssurrogate

This paper describes the protocol for a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of Shenfu Qiangxin Pills in patients with chronic heart failure.

Cite This Study

Guo et al. (2020) conducted an RCT in chronic heart failure (Heart-Kidney yang deficiency syndrome) (n=352). Shenfu Qiangxin Pills (SFQX) vs. placebo was evaluated on plasma N-terminal pro-B-type natriuretic peptide levels. This paper describes the protocol for a randomized, double-blind trial evaluating Shenfu Qiangxin Pills versus placebo for 12 weeks in 352 patients with chronic heart failure.

synapsesocial.com/papers/6aaf60a37e8385fbd3d0650fhttps://doi.org/10.1097/md.0000000000020271
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Efficacy and safety of Shenfuqiangxin pills in complementary treatment of chronic heart failure2021
  2. 2Efficacy 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 Trial2023 · 11 citations
  3. 3A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of Fuzheng Yangxin Granule in treating heart failure with preserved ejection fraction (Qi-Yin deficiency and blood stasis syndrome): study protocol2025 · 3 citations
  4. 4Long-term efficacy and impact on rehospitalization of Qishen granules in patients with hypertension and heart failure with reduced ejection fraction: a multicenter, randomized, double-blind, placebo-controlled trial protocol2026
  5. 5Safety and efficacy of Qishen granules in patients with chronic heart failure: study protocol for a randomized controlled trial2017 · 28 citations