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

Li ZT, Li L, Chen TT, Li CY, Wang DQ, Yang ZF, Zhong NS - Trials (2015)

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: State Key Laboratory of Respiratory Diseases, Guangzhou Institute of Respiratory Disease, National Clinical Centre of Respiratory Disease, The First Affiliated Hospital, Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, 510120, China. tu276025@163.com.

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).

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Related in: MedlinePlus

Study flowchart. Participants with a rapid diagnosis of influenza will be recruited, and they will be assigned randomly into three different groups. All participants will accept the 5-day treatment and 21-day follow-up period observation. The data were collected to determine the treatment efficacy and safety of Ban-Lan-Gen (BLG).
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Fig1: Study flowchart. Participants with a rapid diagnosis of influenza will be recruited, and they will be assigned randomly into three different groups. All participants will accept the 5-day treatment and 21-day follow-up period observation. The data were collected to determine the treatment efficacy and safety of Ban-Lan-Gen (BLG).

Mentions: This clinical study was a randomized, double-blind, double control trial that tested drugs and placebo. Noninferiority (versus positive control) and superiority (versus placebo control) trials were conducted. Patients with positive tests for the influenza virus (rapid detection of antigens to the influenza virus before enrollment, but if detection of nucleic acid of the influenza virus or cultivation of the influenza virus was inconsistent, the patient was excluded) were assigned randomly into three groups of equal proportions (1:1:1). Groups were: oseltamivir treatment (positive control), BLG granule treatment (test group) and placebo group. Patients will accept 5-day treatment and 21-day observation. Patient follow-up was undertaken on days 1, 3, 5, 7, 21 (Table 1 and Figure 1). Specific items that were collected for each follow-up period are outlined in Table 1.Table 1


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

Li ZT, Li L, Chen TT, Li CY, Wang DQ, Yang ZF, Zhong NS - Trials (2015)

Study flowchart. Participants with a rapid diagnosis of influenza will be recruited, and they will be assigned randomly into three different groups. All participants will accept the 5-day treatment and 21-day follow-up period observation. The data were collected to determine the treatment efficacy and safety of Ban-Lan-Gen (BLG).
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4383212&req=5

Fig1: Study flowchart. Participants with a rapid diagnosis of influenza will be recruited, and they will be assigned randomly into three different groups. All participants will accept the 5-day treatment and 21-day follow-up period observation. The data were collected to determine the treatment efficacy and safety of Ban-Lan-Gen (BLG).
Mentions: This clinical study was a randomized, double-blind, double control trial that tested drugs and placebo. Noninferiority (versus positive control) and superiority (versus placebo control) trials were conducted. Patients with positive tests for the influenza virus (rapid detection of antigens to the influenza virus before enrollment, but if detection of nucleic acid of the influenza virus or cultivation of the influenza virus was inconsistent, the patient was excluded) were assigned randomly into three groups of equal proportions (1:1:1). Groups were: oseltamivir treatment (positive control), BLG granule treatment (test group) and placebo group. Patients will accept 5-day treatment and 21-day observation. Patient follow-up was undertaken on days 1, 3, 5, 7, 21 (Table 1 and Figure 1). Specific items that were collected for each follow-up period are outlined in Table 1.Table 1

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: State Key Laboratory of Respiratory Diseases, Guangzhou Institute of Respiratory Disease, National Clinical Centre of Respiratory Disease, The First Affiliated Hospital, Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, 510120, China. tu276025@163.com.

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).

Show MeSH
Related in: MedlinePlus