A Clinical trial of Malbet syrup in pediatric patients with uncomplicated influenza.

Not Applicable

Conditions: Health Condition 1: J118- Influenza due to unidentified influenza virus with other manifestations

Registration Number: CTRI/2023/10/058221

Lead Sponsor: Solar Herbo Pvt. Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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