A clinical trial of Malbet capsules in adult patients with uncomplicated influenza.

Not Applicable

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

Registration Number: CTRI/2023/10/058885

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 18 years and above;2)At the 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 pain, fatigue;3)Fever less than or equal to 103 °F;4)Viral fever, cold, cough and pyrexia of unknown origin irrespective of the type of viral infection as per the discretion of investigator; 5)Comorbid patient on stable medication for the last three months, with no worsening of symptoms and/or need for hospitalization; or can be enrolled into the study as per discretion of investigator.

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.Has underlying chronic respiratory disease; includes bronchial asthma if currently experience asthma symptoms, requires current asthma treatment, or has had an asthma attack in the past year;

5.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 investigators at start of study;

6.Current use of adrenocorticosteroids (except topical preparation) or immunosuppressive drugs;

7.Has a serious chronic disease, history of alcohol or drug abuse within preceding 2 years, psychiatric illness not well controlled (not on stable regimen > 1 year), or is deemed by the investigator to be ineligible for any reason;

8.Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

9.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 alleviate 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: 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 & pyrexia ie time from the start of study treatment until alleviation of each of the following influenza symptoms (cough, sore throat, headache, nasal congestion, body aches, & pains, & fatigue) & to the resolution of pyrexia from baseline to day 5. <br/ ><br>2.Change in secondary influenza symptom i.e. loss of appetite based on Appetite & Food Satisfaction Questionnaire from baseline to day 5Timepoint: Screening, Baseline, Day 2, Day 3, Day 4 & Day 5