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Clinical Trials/CTRI/2023/10/058885
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Solar Herbo Pvt. Ltd.

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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