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Banlangen Granules Anti-seasonal Influenza Study (BLG)

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ClinicalTrials.gov Identifier: NCT02232945
Recruitment Status : Unknown
Verified March 2016 by Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited.
Recruitment status was:  Recruiting
First Posted : September 5, 2014
Last Update Posted : March 4, 2016
Sponsor:
Collaborator:
Guangzhou Institute of Respiratory Disease
Information provided by (Responsible Party):
Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited

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.

Condition or disease Intervention/treatment Phase
Influenza Drug: placebo of oseltamivir phosphate Drug: oseltamivir phosphate Drug: Banlangen (Radix Isatidis) granules Drug: placebo of Banlangen(Radix Isatidis) granules Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Banlangen Granules Anti-seasonal Influenza Study: a Randomized, Double Blind, Positive and Placebo Controlled,Clinical Study.
Study Start Date : April 2012
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Placebo Comparator: placebo
placebo of oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules.
Drug: placebo of oseltamivir phosphate
Drug: placebo of Banlangen(Radix Isatidis) granules
Experimental: Banlangen granules & placebo
Banlangen(Radix Isatidis) granules and placebo of oseltamivir phosphate
Drug: placebo of oseltamivir phosphate
Drug: Banlangen (Radix Isatidis) granules
Active Comparator: oseltamivir phosphate & placebo
oseltamivir phosphate and placebo of Banlangen(Radix Isatidis) granules
Drug: oseltamivir phosphate
Drug: placebo of Banlangen(Radix Isatidis) granules



Primary Outcome Measures :
  1. Improving the flu-like symptoms, such as fever etc [ Time Frame: 21+7days ]
    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.

  2. Improving the flu-like symptoms, such as fever etc [ Time Frame: 21+7days ]
    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.


Secondary Outcome Measures :
  1. others [ Time Frame: 21+7days ]
    viral shedding duration, defined as the time from the illness onset to the first time the viral nucleic acid test was negative

  2. Others [ Time Frame: 21+7days ]
    the severity of the disease,assessed by an area under the curve (AUC) analysis of a total of nine influenza-like symptom scores, the AUC was calculated as the product of the daily symptom scores times the duration of illness

  3. Others [ Time Frame: 21+7days ]
    frequency of Usage of Acetaminophen

  4. Others [ Time Frame: 21+7days ]
    incidence of secondary complications of influenza

  5. Others [ Time Frame: 21+7days ]
    economic evaluation



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  1. age younger than 18 or older than 65 years old.
  2. patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung disease by Chest imaging (chest X-ray or CT) .
  3. Blood routine screening tests shows numeration of leukocyte 10.0×109/L or Neutrophil percentage ≥80%.
  4. Those have got suppurative tonsillitis or cough purulent sputum.
  5. 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)

7. 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).

9. Those with immunodeficiency ,such as malignant tumor ; Organs or bone marrow transplantation ; AIDS ;or taking immune inhibitors during the last 3 months.

10. Doubt or does alcohol/drug abuse of history. 11. Those have participated in other clinical trial within three month before study randomization.

12. Two weeks before the test , those with acute respiratory Infection,otitis,or nasosinusitis .

13. Those already vaccinated or who will receive influenza vaccine. 14.other reasons not suitable for enrollment based on the investigator's discretion.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232945


Contacts
Contact: Yuedong Cai, Master 86-20-66282326 caiyuedong@813zy.com

Locations
China, Guangdong
Guangzhou Institute of Respiratory Disease Recruiting
Guangzhou, Guangdong, China, 510230
Contact: Nan S Zhong, PHD    020-83062718    nanshan@vip.163.com   
Principal Investigator: N S Zhong, PHD         
Sponsors and Collaborators
Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited
Guangzhou Institute of Respiratory Disease
Investigators
Study Chair: Nanshan Zhong, PhD Guangzhou Institute of Respiratory Disease

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited
ClinicalTrials.gov Identifier: NCT02232945     History of Changes
Other Study ID Numbers: HWBY-001
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016

Keywords provided by Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited:
influenza A (H1N1,H3N2)
influenza B virus

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action