Banlangen Granules Anti-seasonal Influenza Study
Banlangen Granules Anti-seasonal Influenza Study
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.
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 two constitutional symptoms (headache,
 chill, myalgia ，or fatigue) and one respiratory symptom (cough ，sore throat,or coryza) .

 4. 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.

 The primary efficacy endpoint:

 1. 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. 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 efficacy endpoint:

 The secondary end points included: 1) viral shedding duration, defined as the time from the
 illness onset to the first time the viral nucleic acid test was negative; 2) 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)frequency of Usage of Acetaminophen;4)and incidence of
 secondary complications of influenza, such as otitis, bronchitis, pneumonia，Nasosinusitis
 ,suppurative tonsillitis,acute parotitis，Reye'ssyndrome，central nervous system disease,
 Myocarditis and pericarditis, acute myositis, and toxic shock syndrome.5) economic
 evaluation.

 Specimen:

 the pharyngeal or the throat swab，blood. Pharyngea /throat secretions will be obtained from
 the upper respiratory tract of each patient.

 All specimens will be stored at -80℃ in virus laboratory of the first affiliated hospital of
 guangzhou medical university for 5 years.
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.