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Safety and efficacy of Qishen granules in patients with chronic heart failure: study protocol for a randomized

Jinping Wang1, Jun Shi1,2, Jiawei Wei1

  • 1Beijing University of Chinese Medicine, Bei San Huan Dong Lu, Chao Yang District, Beijing, 100029, China.

Trials
|October 12, 2017
PubMed

Insights

Qishen granules (QSG) may reduce NT-proBNP levels in chronic heart failure (CHF) patients. This clinical trial will assess the efficacy and safety of QSG as a complementary treatment for CHF.

Area of Science:

  • Cardiology
  • Traditional Chinese Medicine
  • Clinical Pharmacology

Background:

  • Chronic heart failure (CHF) poses a significant public health challenge with high hospitalization and mortality rates.
  • Qishen granules (QSG), a traditional Chinese medicine formula, is used for CHF, with animal studies showing efficacy.
  • No standard clinical trials have yet confirmed QSG's effectiveness in humans.

Purpose of the Study:

  • To evaluate the efficacy and safety of Qishen granules (QSG) in treating chronic heart failure (CHF).
  • To determine if QSG can reduce NT-proBNP levels in CHF patients.
  • To provide high-quality evidence for the clinical application of QSG.

Main Methods:

  • A randomized, placebo-controlled, multi-center, double-blind trial involving 200 CHF patients.
  • Patients will receive either QSG or placebo granules twice daily for 12 weeks.
  • Primary outcome: >30% decrease in NT-proBNP levels; secondary outcomes include cardiac events, NYHA class, 6MWT, LVEF, quality of life, and TCM syndrome scores.

Main Results:

  • The study aims to compare the reduction in NT-proBNP levels between the QSG and placebo groups.
  • Secondary outcome analysis will assess various clinical and functional parameters related to heart failure.
  • Safety and tolerability of QSG will be evaluated throughout the trial.

Conclusions:

  • QSG may offer additional NT-proBNP reduction when used with standard CHF treatments.
  • This trial is expected to provide robust evidence on QSG's efficacy and safety in CHF.
  • Findings will inform the clinical use of QSG for chronic heart failure management.
Abstract

Keywords:
Chronic heart failureEfficacyQishen granulesSafetyTraditional Chinese herbal medicine

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