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

ABSTRACT

BACKGROUND: Ban-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/DESIGN: We 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. DISCUSSION: We 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 REGISTRATION This study has been registered at ClinicalTrials.gov NCT02232945 (3 September 2014).