Echinacea Safety Study

• Research type

  Research Study

• Full title

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

• IRAS ID

  26551

• Eudract number

  2009-012297-12

• ISRCTN Number

  1

• Research summary

  Extracts produced from Echinacea purpurea are traditionally used for the prevention and the acute treatment of flunzal infections like the common cold. The aim of this clinical study is to assess clinical safety and efficacy of a treatment with Echinaforce in comparison to placebo. 750 healthy subjects with a history of equal or more than 2 cold episodes per year will be recruited during October and November 2009 and will be treated with either Echinaforce or placebo over a period of 4 months. Throughout the study period adverse events (AEs) and adverse drug reactions (AEs with at least a possible causal relation to the treatment) will be recorded. Haematological and biochemical parameters as well as differential blood count will be measured before and after treatment in both groups. Common cold related symptoms will be recorded in a daily diary to obtain information on the efficacy of the treatments on common cold.

• REC name

  Wales REC 1

• REC reference

  09/WSE04/41

• Date of REC Opinion

  28 Jul 2009

• REC opinion

  Further Information Favourable Opinion