Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-02-01
2018-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group
Each Flu Care capsule consists of combination of seven polyherbal formulation (350 mg). Participant will be instructed to take one capsule thrice daily at a fixed time in the day for the study duration of 7 days along with 75 mg of Oseltamivir.
polyherbal formulation
Each Flu Care consist of 350 mg of polyherbal component
Oseltamivir 75mg
All the participant has to take 75 mg of oseltamivir for five days.
Standard Care Group
Standard of care consist of 75 mg of Oseltamivir for five days and any other required provision of care. These will be determined on case by case basis by research clinician.
Oseltamivir 75mg
All the participant has to take 75 mg of oseltamivir for five days.
Interventions
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polyherbal formulation
Each Flu Care consist of 350 mg of polyherbal component
Oseltamivir 75mg
All the participant has to take 75 mg of oseltamivir for five days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with a duration of influenza symptoms confirmed by all of the following:
1. Fever ≥ 38º C (axillary) during the predose examinations or within the 4 hours prior if antipyretics were taken
2. At least 1 each of the following general and respiratory symptoms associated with influenza is present with a severity of moderate or greater: i. General symptoms (headache, feverishness or chills, muscle or joint pain, or fatigue) ii. Respiratory symptoms (cough, sore throat, or nasal congestion) Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours prior to first dose
* The time interval between the onset of symptoms and the predose examinations is 48 hours or less. The onset of symptoms is defined as either:
1. Time of the first increase in body temperature (an increase of at least 1º C from normal body temperature)
2. Time when the patient experiences at least 1 new general or respiratory symptom
1. Asthma or chronic lung disease (such as chronic obstructive pulmonary disease or cystic fibrosis)
2. Endocrine disorders (including diabetes mellitus)
3. Residents of long-term care facilities (e.g., nursing homes)
4. Compromised immune system (including patients receiving corticosteroids not exceeding 20 mg of prednisolone or equivalent, and patients being treated for human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 count \> 350 cells/mm³ within the last 6 months)
5. Neurological and neurodevelopmental disorders (including disorders of the brain, spinal cord, peripheral nerve, and muscle, e.g., cerebral palsy, epilepsy \[seizure disorders\], stroke, muscular dystrophy, or spinal cord injury)
6. Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease), excluding hypertension without any other heart-related symptoms
7. Adults aged ≥ 65 years
8. Blood disorders (such as sickle cell disease)
9. Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
10. Morbid obesity (body mass index ≥ 40)
Exclusion Criteria
* Antiviral treatment for influenza in 2 weeks prior to randomization
* Severe Hepatic and renal impairment
* Pregnant, attempting to conceive, or lactating women
18 Years
ALL
No
Sponsors
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Composite Interceptive Med Science
INDUSTRY
Responsible Party
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Principal Investigators
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Dayanand B Yaligar, MBBS
Role: PRINCIPAL_INVESTIGATOR
Narayana Hrudayalaya Hospital
Locations
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Mazumdar Shaw Medical Centre
Bangalore, Karnataka, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OI-008-2017
Identifier Type: -
Identifier Source: org_study_id
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