Safety and Efficacy of long-term treatment with Echinaforce® over 4 months - Echinacea Safety Study
- Conditions
- common cold
- Registration Number
- EUCTR2009-012297-12-GB
- Lead Sponsor
- Bioforce AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 750
On average = 2 cold episodes per year
Age = 18 years
Good physical condition
Signed informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Women without appropriate and effective contraception
Participation in a clinical trial 30 days prior to this trial
Pregnant or breast feeding women
Subjects with pre-existing cold symptoms for more than 24h at inclusion
Concurrent participation in another clinical trial
Intake of antimicrobial and/or antiviral medications at inclusion
Alcohol and/or drug abuse, narcotic drug addiction before and during trial (more than 50 gr and / or 10 cigarettes per day)
Psychiatric disorders which may influence the results of the trial, epilepsy, suicide attempts
Planned surgical intervention during the trial.
Serious chronic diseases which influence the absorption, metabolism and the elimination of the investigational product, especially progressive systemic illnesses like tuberculosis, leukaemia, collagen disorders and multiple sclerosis
Known AIDS, HIV-infections and autoimmune diseases
Known diabetes mellitus (type 1)
Corticosteroid-treated asthma
Atopic and allergic subjects (under medicinal treatment)
Known allergy to plants of the composite family (Asteraceae)
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