An interventional study of polyherbal formulation and Oseltamivir 75mg in Influenza, sponsored by Composite Interceptive Med Science. Status unknown at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-11.
Sponsored by Composite Interceptive Med Science · Not applicable, Interventional, and Treatment
The aim of this study is to determine the efficacy of Flu care polyherbal formulation in the management of acute uncomplicated case of Influenza within 48 hours of symptoms onset.
Influenza is one of the most common epidemics occurring in India during winter months. Most of the commonly used antiviral have limited efficacy and safety in influenza treatment. Flu Care polyherbal consist of antiviral, antitussive and anti-inflammatory herbal medicine. If this Flu care intervention is shown to be effective, there will be major potential benefits to general population.
Patients with a duration of influenza symptoms confirmed by all of the following:
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:
Exclusion Criteria:
Patients will be considered at high risk of influenza complications due to the presence of at least 1 of the following inclusion criteria:
Other Exclusion criteria Any one of the following
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.
Drug: polyherbal formulation · Drug: Oseltamivir 75mg
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.
Drug: Oseltamivir 75mg
Each Flu Care consist of 350 mg of polyherbal component
Also known as: Flu Care
All the participant has to take 75 mg of oseltamivir for five days.
Time to improvement of symptoms
Time to improvement of symptoms is defined as the time from initiation of study treatment to improvement of influenza symptoms for a duration of at least 21.5 hours (24 hours - 10%).
Time frame: Day 1 pretreatment upto Day 7
Percentage change in participants positive for influenza virus titer and viral RNA at end of treatment
Defined as the percentage of patients whose virus titer and ribonucleic acid (RNA) load are become less than the lower limit of quantification among those assessed for virus titer and RNA load. RNA load is measured by reverse transcription polymerase chain reaction (RT-PCR).
Time frame: 7 days
Time to alleviation of symptoms
Time to alleviation of symptoms is defined as the time between the initiation of the study treatment and the alleviation of influenza symptoms. The alleviation of influenza symptoms is defined as the time when all of 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) have been assessed by the patient.
Time frame: Day 1 pretreatment up to Day 7
Time to improvement in the 4 systemic symptoms
Defined as the time between the initiation of the study treatment and the improvement in the 4 systemic symptoms symptoms (headache, feverishness or chills, muscle or joint pain, and fatigue).
Time frame: Day 1 pretreatment up to Day 7
Time to improvement in the 3 respiratory symptoms
Defined as the time between the initiation of the study treatment and the improvement in the 3 respiratory symptoms (cough, sore throat, and nasal congestion).
Time frame: Day 1 pretreatment up to Day 7
Time to resolution of fever
Defined as the time between the initiation of the study treatment and the resolution of fever. The resolution of fever is defined as the time when the patient's self-measured temperature becomes less than 37º C.
Time frame: Day 1 pretreatment up to Day 7
Percentage of participants with adverse events
Time frame: Baseline up to Day 7
Percentage of participants who had been hospitalized
Time frame: Baseline up to Day 7
Percentage of participants with influenza-related complications
Defined as the percentage of patients who experience each influenza-related complication (hospitalization, death, sinusitis, otitis media, bronchitis, and radiologically-confirmed pneumonia) as an adverse event after the initiation of study treatment.
Time frame: Baseline up to Day 7
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Composite Interceptive Med Science