Efficacy of Oscillococcinum® in the treatment of Influenza-like-illness symptoms

Efficacy of Oscillococcinum® in the treatment of Influenza-like-illness symptoms: a national, multicentre, randomized, controlled trial - GOSCI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002972-11-FR

Enrollment

800

Registered

2020-09-21

Start date

2020-09-21

Completion date

Unknown

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza-like illness (ILI) symptoms

Interventions

Trade Name: Oscillococcinum Product Name: Oscillococcinum Pharmaceutical Form: Pillules INN or Proposed INN: Oscilllococcinum Other descriptive name: Anas barbariae, hepatis et cordis extractum Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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), of less than 24h hours duration. - Patients able to take the first dose of study medication within 24 hours following the first symptoms of ILI. 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

Exclusion criteria

Exclusion criteria: - Patients refusing to sign the informed consent, - Patients with unstable or 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 the study completion or 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 - 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of Oscillococcinum® in the alleviation of ILI symptoms within 72h following the beginning of the first intake of medication.;Secondary Objective: •To assess the effects of Oscillococcinum® on: -The alleviation of ILI symptoms within the first 72 hours (primary objective) and maintained over at least 24 hours -The alleviation of ILI symptoms within the first 48 hours following the beginning of the treatment -The reduction of time to alleviation of symptoms -The improvement of the ability to perform daily activities •To describe the effects of Oscillococcinum® on : -The improvement of sleep quality -The alleviation of other symptoms (fatigue, nasal congestion, gastro-intestinal disturbances) -The decrease in the development of secondary outcomes •To describe the patient’s compliance regarding the use of Oscillococcinum •To evaluate the tolerability of Oscillococcinum •To evaluate the patients’ and physicians’ satisfaction regarding the efficacy of Oscillococcinum. ;Primary end point(s): 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. Definition of ILI: According to the definition of the Official Journal of European Union (OJEU) (1) ILI is defined as: •A sudden apparition of symptoms •AND at least one of the three following respiratory symptoms: cough, sore throat, shortness of breath •AND at least one of the four following systemic symptoms: fever or feverishness, headache, malaise, myalgia. Fever is considered as body temperature = 37.8 °C (2) . Feverishness is defined as the patient’s subjective symptom of feeling like they had a fever or chill. Assessment of ILI symptoms: Patients will assess each symptom of ILI difined above as none, mild, moderate or severe on a diary. Regarding fever, they will indicate their body temperature with a digital thermometer through oral route. The definitio	—

Measure

Time frame

Main Objective: To evaluate the efficacy of Oscillococcinum® in the alleviation of ILI symptoms within 72h following the beginning of the first intake of medication.;Secondary Objective: •To assess the effects of Oscillococcinum® on: -The alleviation of ILI symptoms within the first 72 hours (primary objective) and maintained over at least 24 hours -The alleviation of ILI symptoms within the first 48 hours following the beginning of the treatment -The reduction of time to alleviation of symptoms -The improvement of the ability to perform daily activities •To describe the effects of Oscillococcinum® on : -The improvement of sleep quality -The alleviation of other symptoms (fatigue, nasal congestion, gastro-intestinal disturbances) -The decrease in the development of secondary outcomes •To describe the patient’s compliance regarding the use of Oscillococcinum •To evaluate the tolerability of Oscillococcinum •To evaluate the patients’ and physicians’ satisfaction regarding the efficacy of Oscillococcinum. ;Primary end point(s): 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. Definition of ILI: According to the definition of the Official Journal of European Union (OJEU) (1) ILI is defined as: •A sudden apparition of symptoms •AND at least one of the three following respiratory symptoms: cough, sore throat, shortness of breath •AND at least one of the four following systemic symptoms: fever or feverishness, headache, malaise, myalgia. Fever is considered as body temperature = 37.8 °C (2) . Feverishness is defined as the patient’s subjective symptom of feeling like they had a fever or chill. Assessment of ILI symptoms: Patients will assess each symptom of ILI difined above as none, mild, moderate or severe on a diary. Regarding fever, they will indicate their body temperature with a digital thermometer through oral route. The definitio

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Secondary

Measure	Time frame
Secondary end point(s): •Alleviation of ILI symptoms within 72h according to the primary outcome and maintained over at least 24h. Reappearance or worsening of ILI symptoms will be assessed through daily reports of ILI symptoms by the patient until Final Visit. •Alleviation of ILI symptoms recorded at inclusion within 48h following the initiation of treatment •The reduction of time to alleviation of symptoms will bi assessed through several criteria: -Time to alleviation of symptoms of ILI, defined as the time needed for alleviation of systemic flu-like symptoms, including no fever (body temperature <37.8°C) or reduction of 0.5°C from baseline AND alleviation of respiratory flu-like symptoms. -Time to alleviation of systemic flu-like symptoms. -Time to alleviation of respiratory flu-like symptoms. -Time to alleviation of each symptom. •To evaluate the efficacy of Oscillococcinum in the improvement of the ability to perform daily activities” -Time to return to usual daily activities and perform these as normal. Usual daily activities will be captured by the patient once a day in the evening based on the following criteria ‘Activities you normally would have done today’. 'These activities will be accessessed as ‘not possible’, ‘possible but difficult’, or ‘can be done as normal’, -Number of days of absence from work/school (if applicable). These data will be captured by the patient during the Final Visit, - Number of days with sick certificate: the days covered by a sick certificate will be recorded by the patient during the Final Visit, as appropriate. •To descrive the improvement of sleep quality The improvement of sleep quality, recorded in a Visual Analogic Scale once a day (at morning). • To describe the alleviation of other symptoms Alleviation of other ILI symptoms such as fatigue, nasal congestion and gastro-intestinal disturbances will be described at 72h. These symptoms will be recorded as main ILI symptoms three times a day during the first 72h and	—

Measure

Time frame

Secondary end point(s): •Alleviation of ILI symptoms within 72h according to the primary outcome and maintained over at least 24h. Reappearance or worsening of ILI symptoms will be assessed through daily reports of ILI symptoms by the patient until Final Visit. •Alleviation of ILI symptoms recorded at inclusion within 48h following the initiation of treatment •The reduction of time to alleviation of symptoms will bi assessed through several criteria: -Time to alleviation of symptoms of ILI, defined as the time needed for alleviation of systemic flu-like symptoms, including no fever (body temperature <37.8°C) or reduction of 0.5°C from baseline AND alleviation of respiratory flu-like symptoms. -Time to alleviation of systemic flu-like symptoms. -Time to alleviation of respiratory flu-like symptoms. -Time to alleviation of each symptom. •To evaluate the efficacy of Oscillococcinum in the improvement of the ability to perform daily activities” -Time to return to usual daily activities and perform these as normal. Usual daily activities will be captured by the patient once a day in the evening based on the following criteria ‘Activities you normally would have done today’. 'These activities will be accessessed as ‘not possible’, ‘possible but difficult’, or ‘can be done as normal’, -Number of days of absence from work/school (if applicable). These data will be captured by the patient during the Final Visit, - Number of days with sick certificate: the days covered by a sick certificate will be recorded by the patient during the Final Visit, as appropriate. •To descrive the improvement of sleep quality The improvement of sleep quality, recorded in a Visual Analogic Scale once a day (at morning). • To describe the alleviation of other symptoms Alleviation of other ILI symptoms such as fatigue, nasal congestion and gastro-intestinal disturbances will be described at 72h. These symptoms will be recorded as main ILI symptoms three times a day during the first 72h and

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Countries

Belgium, France

Contacts

Public ContactProjects management desk

KAPPA SANTE

gosci@kappasante.com3301 44 82 74 74

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026