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BMC Complementary Medicine and Therapies

RDN for the treatment of influenza in children: a randomized, double-blinded, parallel-controlled clinical trial

  • Open Access
  • 01-12-2023
  • Influenza
  • Study Protocol
Published in:
Authors
Shuo Yang
Yan-ming Xie
Lian-xin Wang
Published in
BMC Complementary Medicine and Therapies | Issue 1/2023

Abstract

Background

The morbidity of influenza in children increased rapidly in decade. Reduning injection (RDN), a small but fine Chinese herbal formula, has antipyretic, antiviral, anti-inflammatory effects. We intend to evaluate the efficacy and safety of RDN for the influenza in children versus Oseltamivir, explore the possible antiviral mechanism of RDN and provide evidence-based medical evidence for rational clinical drug usage.

Method

We design a randomized, double-blind, double-dummy, parallel control of positive drug, multi-centre clinical study. According to the formula of mean superiority test, a total of 240 patients with influenza in children will be randomized 1:1 into the experimental group and control group. The experimental group will take RDN and Oseltamivir phosphate granule simulants and the control group will take Oseltamivir phosphate granule and RDN simulants. Each group will be treated for 5 days. The primary outcome measure is temperature recovery time, and the secondary outcome measures include time when the fever begins to subside, time and degree of disease to alleviate, disappearance rate of individual symptoms and so on. We will measure before enrollment and each 24 h after treatment for comparison.

Discussion

The study is launched to evaluate the efficacy and safety of RDN for the treatment of influenza in children and to provide an alternative option for influenza in children.

Trial registration

This study is registered in ClinicalTrials.gov as NCT04183725, registered on 3 December, 2019.
Title
RDN for the treatment of influenza in children: a randomized, double-blinded, parallel-controlled clinical trial
Authors
Shuo Yang
Yan-ming Xie
Lian-xin Wang
Publication date
01-12-2023
Publisher
BioMed Central
Published in
BMC Complementary Medicine and Therapies / Issue 1/2023
Electronic ISSN: 2662-7671
DOI
https://doi.org/10.1186/s12906-023-04037-1
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