Influenza Clinical Trial
Official title:
Banlangen Granules Anti-seasonal Influenza Study: a Randomized, Double Blind, Positive and Placebo Controlled,Clinical 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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