acute uncomplicated influenza
Conditions
Interventions
Product Name: Echinaforce Hotdrink
Pharmaceutical Form: Syrup
Other descriptive name: Echinacea purpurea radix et herba
Concentration unit: g/ml gram(s)/millilitre
Concentration type: equal
Concentrat
Sponsors
Bioforce AG Roggwil TG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Fever defined as body temperature (axillary) =37,8°C · Presence of one or more respiratory symptoms (cough, sore throat, nasal symptoms) · Presence of one or more constitutional symptoms (headache, malaise, myalgia, sweats and/or chills, fatigue) · Onset of symptoms 40 kg · Good general condition · Signed informed consent Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: · Subjects with pre-existing influenza symptoms for more than 48 hours at inclusion visit V1 · Suspected bacterial infection · Bronchitis or Pneumonia · Intake of antimicrobial agents in the past month · Antibiotics (Penicilline, Sulfonamides, Quinolones, etc.) · Antivirals (Zanamivir, Amantadine, Rimantadine, Interferones) · Benzoic acid · Broncho Vaxom · any herbal preparation · Influenza vaccination in the past 12 months · Weight 70 years at enrolment · Intake of systemic steroid or immune-suppressive medications at inclusion or in the past 2 months · Women without appropriate and effective contraception · Pregnant or breast feeding women · Chronic cardiac diseases (congenital heart disease, congestive heart failure, coronary artery disease) · Known endocrine disorders like diabetes mellitus (type 1) · Liver and kidney disorders · Respiratory disorders (COPD or cystic fibrosis) · Known Asthma · Serious chronic diseases which influence the absorption, me-tabolism and the elimination of the investigational product, especially progressive systemic illnesses like tuberculosis, leukae-mia, collagen disorders and multiple sclerosis · Other clinically significant chronic diseases · Known AIDS, HIV-infections and auto-immune diseases · Illness requiring hospitalisation · Atopic and allergic subjects (under medicinal treatment) · Known allergy to plants of the composite family (Asteraceae) or to Oseltamivir · Known allergy to Paracetamol and Dextromethorphan · Psychiatric disorders which may influence the results of the trial (epilepsy, suicide attempts) · Risk population of developing complications: chronic respiratory, cardiovascular (excluding hypertension) or metabolic disorders and immune-compromised · Neurological and neuro-developmental condition · Planned surgical intervention during the trial · Alcohol and/or drug abuse, narcotic drug addiction before and during trial (more than 50 g and / or 10 cigarettes per day) · Concurrent participation in another clinical trial · Participation in a clinical trial 30 days prior to this trial · Incapability of understanding the language in which the information for the patient is given · The patient is the investigator him/herself
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove the non-inferiority of Echinaforce Hotdrink compared to Tamiflu in patients with symptoms of acute uncomplicated influenza;Secondary Objective: Safety and tolerability of Echinaforce Hotdrink compared to Tamiflu ;Primary end point(s): Cumulative proportion of alleviated patients after 1 day, 5 days and 10 days of treatment, i.e. when influenza symptoms (cough, nasal obstruction, sore throat, fatigue, headache, myalgia and feverish-ness) are rated as absent or mild in the evening and remain so for 24 hours.;Timepoint(s) of evaluation of this end point: 1 day, 5 days and 10 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Derived from the diary: · Evaluation of further influenza symptoms (fever, malaise, sweats and/or chills) · Sleeping disturbance (number of days during study period) · Time point of return to normal activity · Use of rescue medication Reported by the investigator: · Additional health care contact during the treatment period · Proportion of subjects with complications (pneumonia, sinusitis, bronchitis, etc.) · antibiotic use · Hospitalisation due to influenza · Final assessment of efficacy and tolerability by patient and investigator;Timepoint(s) of evaluation of this end point: daily by means of diary, after 10 days by investigator | — |
Countries
Czech Republic
Contacts
Public ContactProject Management
Phamos CEE s.r.o.
Outcome results
None listed