Health Condition 1: J111- Influenza due to unidentified influenza virus with other respiratory manifestations
Conditions
Interventions
Intervention1: Oscillococcinum®: Oscillococcinum® will contain the extract from Anasbarbariae, hepatis and cordis 200K plus 0.85 g sucrose plus 0.15 g lactose.
Dosing frequency 3 doses/pills bottles
it will not be possible to differentiate it from Oscillococcinum® by its appearance and taste.
Dosing frequency is 3 doses/pills bottles per day over 3 days.
Sponsors
Boiron Laboratoires
Eligibility
Inclusion criteria
Inclusion criteria: 1.Aged 6 years to 12 years for Paediatrics population or Aged 18 years up to 65 years for adult population 2.Patients or parents of patients accepting to participate in the study through signing informed consent 3.Patients with ILI defined as sudden onset of symptoms and at least one of the following systemic symptoms fever (=37.8°C)/ 100.04° F or feverishness (feeling of fever or a chill) malaise headache, myalgia (assessment mild, moderate or severe for at least one of these symptoms) and at least one of the following respiratory symptom cough, sore throat, shortness of breath (assessment mild, moderate or severe for at least one of these symptoms), of less than 24h hours duration. 4.Patients able to take the first dose of study medication in the 24 hours following the first symptoms of ILI.
Exclusion criteria
Exclusion criteria: 1.Patients and parents refusing to sign the informed consent 2.Patients with unstable and uncontrolled renal, cardiac, pulmonary, vascular, neurologic, metabolic (diabetes, thyroid disorders, adrenal disease), or immunodeficiency disorders, cancer, hepatitis, cirrhosis, asthma or chronic obstructive pulmonary disease (COPD) 3.Participation in a clinical study with an investigational drug within 4 weeks prior to study entry 4.Patients who experienced a previous episode of acute upper respiratory tract infection (URTI), sinusitis, bronchitis, otitis or pneumonia within 4 weeks prior to the Initial Visit 5.Patients taking corticosteroids or immuno-suppressant therapies within 2 months prior to the Initial Visit 6.Patients with evidence history of alcoholism, drug abuse, psychiatric disorders (including dementia or dementia like syndrome) or any other medical condition that could affect data collection 7.Treatment within 2 weeks prior to the Initial Visit with antiviral drugs such as neuraminidase inhibitors (Oseltamivir, zanamivir, laninamivir octanoate), or amantadine 8.Treatment within 1 week prior to Initial Visit with Oscillococcinum or antibiotics related to respiratory tract infection 9.Treatment within 1 week prior to Initial Visit with antipyretics other than paracetamol, analgesics, decongestants 10.Treatment within 1 week prior to Initial Visit with homeopathic medicine related to ILI at baseline or any other herbal medicine product or dietary supplement known to affect immune and or inflammatory response 11.Patients with any other disease that requires immediate start of antibiotic treatment related to respiratory tract 12.Pregnant or breast-feeding women 13.Patients with intolerance of fructose, malabsorption of glucose or galactose, sucrase/isomaltase deficit 14.Any other condition which according to the investigator’s judgement is not compatible with the principles of the study, e.g. inability to give informed consent, inability to complete the diary. 15.Patients whom positive Covid-19 test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the proportion of patients with alleviation of ILI symptoms recorded at baseline within 72 hours following the initiation of treatment at initial visit.Timepoint: Day 1 and Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effects of Oscillococcinum To evaluate the efficacy of Oscillococcinum in the improvement of the ability to perform daily activities To describe the improvement of sleep quality. To describe the alleviation of other symptoms. To describe the efficacy of Oscillococcinum in the decrease of development of secondary complications To describe the patients and physicians satisfaction regarding the efficacy of Oscillococcinum To evaluate the tolerability of OscillococcinumTimepoint: Day 1 and Day 10 | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
IR Innovate Research Pvt. Ltd.
Outcome results
None listed