Efficacy of Oscillococcinum® in the treatment of Influenza-like-illness symptoms
- Conditions
- Influenza-like illness (ILI) symptomsTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2020-002972-11-BE
- Lead Sponsor
- BOIRO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
•Aged = 18
•Patients accepting to participate in the study through signing informed consent;
•Patients with ILI defined as sudden onset of symptoms and at least one of the following systemic symptoms: fever (=37.8°C) 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), less than 24 hours duration.
•Patients able to take the first dose of study medication in the 24 hours following the first symptoms of ILI
•Patients agreeing to receive notifications by SMS and/or email to to remind them of the diary completion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
•Patients refusing to sign the informed consent,
•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)
•Participation in a clinical study with an investigational drug within 4 weeks prior to study entry
•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
•Patients taking corticosteroids or immuno-suppressant therapies within 2 months prior to the Initial Visit
•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
•Treatment within 2 weeks prior to the Initial Visit with antiviral drugs such as neuraminidase inhibitors (Tamiflu®, Relenza®, Inavir®), or amantadine (Symmetrel®)
•Treatment within 1 week prior to Initial Visit with Oscillococcinum® or antibiotics related to respiratory tract infection
•Treatment within 1 week prior to Initial Visit with antipyretics other than paracetamol, analgesics, decongestants
•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
•Patients with any other disease that requires immediate start of antibiotic treatment related to respiratory tract
•Pregnant or breast-feeding women
•Patients with intolerance of fructose, malabsorption of glucose or galactose, sucrase/isomaltase deficit
•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 electronic diary
•(For France) Unaffiliated or non-beneficiary of a social security system patient as well as deprived of liberty (article L1121-6 of Code de la Santé Publique) or protected (article L1121-8) adults. (For Belgium) Adult patient deprived of liberty or incapable
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method