CTRI/2023/10/058885
Not Yet Recruiting
N/A
A clinical study to evaluate the efficacy & safety of Malbet capsules in adult patients with uncomplicated influenza. - Nil
Solar Herbo Pvt. Ltd.0 sites0 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Health Condition 1: J118- Influenza due to unidentified influenza virus with other manifestations
- Sponsor
- Solar Herbo Pvt. Ltd.
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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