Efficacy and safety of Ban-Lan-Gen granules in the treatment of seasonal influenza: study protocol for a randomized controlled trialReportar como inadecuado




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Trials

, 16:126

First Online: 28 March 2015Received: 16 December 2014Accepted: 11 March 2015DOI: 10.1186-s13063-015-0645-x

Cite this article as: Li, Z., Li, L., Chen, T. et al. Trials 2015 16: 126. doi:10.1186-s13063-015-0645-x

Abstract

BackgroundBan-Lan-Gen BLG is a traditional Chinese herbal medicine. It has been used for the prevention and treatment of virus-related respiratory diseases such as influenza virus infection. BLG contains some antiviral compounds, but few evidence-based clinical studies have been conducted to assess its efficacy against influenza. We assessed the effects of BLG including efficacy and safety on the treatment of seasonal influenza in an evidence-based clinical trial.

Methods-DesignWe conducted a randomized, double-blinded, oseltamivir- and placebo-controlled, parallel-design clinical trial. A total of 177 subjects are going to be recruited after satisfying the criteria: i 18 to 65 years of age; ii illness onset within 36 h; 3 axillary temperature ≥38.0°C; and iv positive influenza type A-B virus test. Subjects will be assigned randomly into three groups in equal proportions: oseltamivir treatment, BLG granule treatment, and placebo treatment. Each group receives 5-day treatment and is followed up 1, 3, 5, 7 and 21 days later. Symptoms and patient compliance are recorded, and virus-serum viral antibodies tested. We will use the primary outcome, secondary outcome, and safety indicators to evaluate the efficacy and safety of BLG granules in the treatment of seasonal influenza.

DiscussionWe have described the first clinical trial for treatment using a single herb against influenza A and B viruses in China. We will hold a large-scale clinical trial to comprehensively evaluate the effectiveness and safety of BLG against influenza infection based on the results of this pilot study. And this clinical trial will serve as an example for the study of other traditional herbal medicines in evidence-based clinical trials.

Trial registrationThis study has been registered at ClinicalTrials.gov: NCT02232945 3 September 2014.

KeywordsBan-Lan-Gen granule Seasonal influenza Oseltamivir Evidence-based clinical trial AbbreviationsAUCarea under the curve

BMIbody mass index

CRFcase report form

CKcreatine kinase

CK-MBcreatine kinase isoenzyme

GCPgood clinical practice

HAhemagglutinin

IIRIsatis indigotica root

ILIinfluenza-like illness

IRPSIsatis indigotica root polysaccharide

ITTPintent-to-treat population

LOCFlast observation carried forward

MITTPmodified intent-to-treat population

NAneuraminidase

PPPper-protocol population

SAPsafety analysis population

TCHMTraditional Chinese herbal medicine

Zheng-tu Li and Li Li contributed equally to this work.

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-015-0645-x contains supplementary material, which is available to authorized users.

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Autor: Zheng-tu Li - Li Li - Ting-ting Chen - Chu-yuan Li - De-qin Wang - Zi-feng Yang - Nan-shan Zhong

Fuente: https://link.springer.com/



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