Influenza
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Each Flu Care consist of 350 mg of polyherbal component
DRUGOseltamivir 75mg
All the participant has to take 75 mg of oseltamivir for five days.
Sponsors
Composite Interceptive Med Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label study
Intervention model description
Parallel follow up of two groups randomly allocated through a central randomization process.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects above the age of 18 years, providing written informed consent. * 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
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: 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) Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to improvement of symptoms | Day 1 pretreatment upto Day 7 | 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%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to alleviation of symptoms | Day 1 pretreatment up to Day 7 | 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 to improvement in the 4 systemic symptoms | Day 1 pretreatment up to Day 7 | 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 to improvement in the 3 respiratory symptoms | Day 1 pretreatment up to Day 7 | 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). |
| Percentage change in participants positive for influenza virus titer and viral RNA at end of treatment | 7 days | 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). |
| Percentage of participants with adverse events | Baseline up to Day 7 | — |
| Percentage of participants who had been hospitalized | Baseline up to Day 7 | — |
| Percentage of participants with influenza-related complications | Baseline up to Day 7 | 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 to resolution of fever | Day 1 pretreatment up to Day 7 | 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. |
Countries
India
Contacts
Primary ContactAlben Sigamani, MD
Backup ContactSanjaya Chauhan, Pharm.D
Outcome results
None listed