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RDN for the treatment of influenza in children: a randomized, double-blinded, parallel-controlled clinical trial
Shuo Yang1,2, Yan-Ming Xie3,4, Lian-Xin Wang5,6
1Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
Insights
Reduning injection (RDN) shows promise as a safe and effective treatment for pediatric influenza, offering an alternative to Oseltamivir. This study evaluates RDN
Area of Science:
- Pediatric infectious diseases
- Pharmacology
- Traditional Chinese Medicine
Background:
- Influenza morbidity in children has risen.
- Reduning injection (RDN) is a Chinese herbal formula with antipyretic, antiviral, and anti-inflammatory properties.
- Evaluating RDN for pediatric influenza is crucial.
Purpose of the Study:
- To assess the efficacy and safety of RDN compared to Oseltamivir for pediatric influenza.
- To explore the antiviral mechanisms of RDN.
- To provide evidence for rational clinical use of RDN.
Main Methods:
- Randomized, double-blind, double-dummy, multi-center clinical trial.
- 240 pediatric patients with influenza randomized 1:1 to RDN or Oseltamivir.
- Primary outcome: temperature recovery time; secondary outcomes: fever subsidence, symptom alleviation, symptom disappearance.
Main Results:
- Temperature recovery time was the primary outcome measure.
- Secondary outcomes included fever subsidence and symptom alleviation.
- Data collected pre-enrollment and every 24 hours post-treatment.
Conclusions:
- The study aims to evaluate RDN's efficacy and safety in children with influenza.
- RDN may offer an alternative treatment option for pediatric influenza.
- Evidence-based data will support clinical drug usage.
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.
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