Status:
UNKNOWN
Banlangen Granules Anti-seasonal Influenza Study
Lead Sponsor:
Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited
Collaborating Sponsors:
Guangzhou Institute of Respiratory Disease
Conditions:
Influenza
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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.
Detailed Description
Inclusion criteria: 1. Patients have confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real time PCR 2. age between 18-65 years old 3. axillary temperature ≥38ºC and with at least tw...
Eligibility Criteria
Inclusion
- 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
- 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)
- 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.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2016
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT02232945
Start Date
April 1 2012
End Date
November 1 2016
Last Update
March 4 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, China, 510230