Health Condition 1: J118- Influenza due to unidentified influenza virus with other manifestations
Conditions
Interventions
Intervention1: Malbet Syrup: 5 ml 3 times a day after meals for 5 days
Control Intervention1: NIL: NIL
Sponsors
Solar Herbo Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1)Male and female patients of age of 6-12 (Both inclusive) years visiting the outpatient department of the study center;2)Viral fever, cold, cough and pyrexia of unknown origin irrespective of the type of viral infection as per the discretion of investigator;3)At time of enrollment has 2 or more of the following symptoms (moderate to severe in intensity based on 5-point Linkert scale) that began 48 hours or less prior to the anticipated start of dosing with study medication: cough, sore throat, headache, nasal congestion, body aches and pains, fatigue;4)Has a fever less than or equal to 103 °F at the first visit or in the 6 hours prior if antipyretics were taken.
Exclusion criteria
Exclusion criteria: 1.Patients who required hospitalization at the time of screening; 2.Fever > 103 °F; 3.Has taken an anti-influenza drug, or received any live attenuated influenza vaccine within 4 weeks prior to signing the informed consent; 4.Suspected bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung observed on chest x ray, or is on antibiotics for pulmonary disease) as per discretion of investigator at the start of study; 5.Patients having any congenital abnormality or epileptic attack 6.Current use of adrenocorticosteroids (except topical preparation) or immunosuppressive drugs; 7.Any other clinical condition which may jeopardize the study outcome or patient health in any way as per discretion of investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Time required to alleviation of all primary influenza symptoms and pyrexia (clinical recovery) i.e. time from the start of study treatment until alleviation of all primary influenza symptoms (i.e. cough, sore throat, headache, nasal congestion, body aches and pains, fatigue) and to resolution of pyrexia from baseline to day 5.Timepoint: screening, baseline, day 2, Day 3, Day 4 and Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in time to alleviation of each of the primary influenza symptoms and pyrexia i.e. time from the start of study treatment until alleviation of each of the following influenza symptoms (cough, sore throat, headache, nasal congestion, body aches, and pains, and fatigue) and to the resolution of pyrexia from baseline to day 5.Timepoint: screening, baseline, day 2, Day 3, Day 4 and Day 5 | — |
Countries
India
Contacts
Public ContactMr Manoj Gune
Mprex Healthcare Pvt Ltd
Outcome results
None listed