Safety and Efficacy of long-term treatment with Echinaforce® over 4 months - Echinacea Safety Study

INTERVENTION: 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) Concentration type: equal Concentration number: 2.7‐4.5 CONDITION: common cold PRIMARY OUTCOME: 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 Primary end point(s): Confirmation of non‐inferiority of Echinaforce® compared to placebo in the incidence of Adverse Drug Reactions. ; 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. 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