common cold
Conditions
Interventions
Trade Name: Echinaforce (Echinacea drops)
Product Name: Echinaforce (Echinacea drops)
Pharmaceutical Form: Oral drops*
INN or Proposed INN: Echinaforce tincture
Concentration unit: ml millilitre(s)
Co
Sponsors
Bioforce AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The herbal medicine extract of Echinacea has been widely used to help prevent colds for over 50 years in Europe and the USA. Although the medicine has been used safely for long term treatment over several months during the common cold season without any safety issues, the EU regulatory authorities now require confirmatory safety data for this prophylactic use of the medicine before granting a license for long term use of the medicine. This study will investigate the safety profile of a 4-month's prophylactic treatment with Echinaforce (an herbal extract from Echinacea purpurea)by measuring adverse events and adverse drug reactions (with one at least possible causal relation to the study drug). The occurrence of events are compared after "non-inferiority" to the treatment with placebo (inactive treatment, sham-treatment). In addition, blood samples are drawn before and after treatment and analyzed for any changes regarding haematological and biochemical measures. Leukocytes and Lym;Secondary Objective: Secondary aims are to investigate the efficacy of Echinaforce to prevent common cold episodes in comparison to placebo and to look at its efficacy to reduce severity and duration of the occurring cold episodes, again in comparison to placebo.;Primary end point(s): Confirmation of non-inferiority of Echinaforce® compared to placebo in the incidence of Adverse Drug Reactions. | — |
Countries
United Kingdom
Outcome results
None listed