Banlangen Granules Anti-seasonal Influenza Study

NCT02232945 | Unknown Phase 4 DMC

• 1 other identifier: HWBY-001
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the efficacy and safety of the nature herbal medicine Banlangen granules in patients infected with seasonal influenza A (H1N1,H3N2) and influenza B virus.

Conditions

Influenza

Keywords

influenza A (H1N1,H3N2); influenza B virus

Outcome Measures

Primary Outcomes (2)

• Improving the flu-like symptoms, such as fever etc

  The primary end point was the duration of illness which was defined as the time from onset of symptoms to the alleviation of the ten influenza-like symptoms including , nasal obstruction, running nose, cough, sore throat, headache, fatigue, myalgia, chills and sweating.

  21+7days

• Improving the flu-like symptoms, such as fever etc

  The time to defervescence, defined as the time from the first dose of study medication to the time when the body temperature declined to lower than 37.4ºC and was sustained for at least 24 hours.

  21+7days

Secondary Outcomes (5)

• others

  21+7days

• Others

  21+7days

• Others

  21+7days

• Others

  21+7days

• Others

  21+7days

Study Arms (3)

placebo

PLACEBO COMPARATOR

placebo of oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules.

Drug: placebo of oseltamivir phosphate; Drug: placebo of Banlangen(Radix Isatidis) granules

Banlangen granules & placebo

EXPERIMENTAL

Banlangen(Radix Isatidis) granules and placebo of oseltamivir phosphate

Drug: placebo of oseltamivir phosphate; Drug: Banlangen (Radix Isatidis) granules

oseltamivir phosphate & placebo

ACTIVE COMPARATOR

oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules

Drug: oseltamivir phosphate; Drug: placebo of Banlangen(Radix Isatidis) granules

Interventions

placebo of oseltamivir phosphate DRUG

Banlangen granules & placebo; placebo

oseltamivir phosphate DRUG

oseltamivir phosphate & placebo

Banlangen (Radix Isatidis) granules DRUG

Banlangen granules & placebo

placebo of Banlangen(Radix Isatidis) granules DRUG

oseltamivir phosphate & placebo; placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real time RT-PCR (rRT-PCR), age between 18-65 years old, axillary temperature ≥38ºC and with at least two constitutional symptoms (headache, chill, myalgia ，or fatigue) and one respiratory symptom (cough ，sore throat,or coryza) . Illness onset had to be within 36 hours, and informed consent was obtained.

You may not qualify if:

• age younger than 18 or older than 65 years old.
• patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung disease by Chest imaging (chest X-ray or CT) .
• Blood routine screening tests shows numeration of leukocyte 10.0×109/L or Neutrophil percentage ≥80%.
• Those have got suppurative tonsillitis or cough purulent sputum.
• Those with underling primary disorders, such as hematological disease, chronic obstructive pulmonary disease（FEV1/FVC\<70％，FEV1/ predicated value\<50％； or respiratory failure or right heart failure）， hepatic disease（ALT or AST≥triple ULN）, renal disease（Serum Creatinine\>2mg/dL）,chronic congestive heart failure( NYHA Ⅲ-IV)
• \. Patient is allergic to the study medication(s). 8. Women who are pregnant or may possibly become pregnant or are lactating with a positive urine pregnant test, obesity (abody mass index (BMI) of 25 kg/m2 or more).
• \. Those with immunodeficiency ,such as malignant tumor ; Organs or bone marrow transplantation ; AIDS ;or taking immune inhibitors during the last 3 months.
• \. Doubt or does alcohol/drug abuse of history. 11. Those have participated in other clinical trial within three month before study randomization.
• \. Two weeks before the test , those with acute respiratory Infection，otitis,or nasosinusitis .
• \. Those already vaccinated or who will receive influenza vaccine. 14.other reasons not suitable for enrollment based on the investigator's discretion.

Sponsors & Collaborators

• Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited: lead
• Guangzhou Institute of Respiratory Disease: collaborator

Study Sites (1)

Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, 510230, China

RECRUITING

Related Publications (1)

• Li ZT, Li L, Chen TT, Li CY, Wang DQ, Yang ZF, Zhong NS. Efficacy and safety of Ban-Lan-Gen granules in the treatment of seasonal influenza: study protocol for a randomized controlled trial. Trials. 2015 Mar 28;16:126. doi: 10.1186/s13063-015-0645-x.

  PMID: 25873046 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir; banlangen

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Nanshan Zhong, PhD

  Guangzhou Institute of Respiratory Disease

  STUDY CHAIR

Central Study Contacts

Yuedong Cai, Master

CONTACT

86-20-66282326; caiyuedong@813zy.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2012
• First Posted: September 5, 2014
• Study Start: April 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

CN (1)