Echinacea Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01021995
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : July 23, 2014
Information provided by (Responsible Party):
Bioforce AG

November 30, 2009
December 1, 2009
July 23, 2014
October 2009
August 2010   (Final data collection date for primary outcome measure)
Occurrence of Adverse Drug Reactions [ Time Frame: 4 months ]
Same as current
Complete list of historical versions of study NCT01021995 on Archive Site
efficacy [ Time Frame: 4 months ]
Same as current
Not Provided
Not Provided
Echinacea Safety Study
Safety and Efficacy of Long-term Treatment With Echinaforce® Over 4 Months

Extracts produced from Echinacea purpurea are traditionally used for the prevention and the acute treatment of influenzal infections like the common cold. The aim of this clinical study is to assess clinical safety and efficacy of a treatment with Echinacea 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 Echinacea 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.

Common cold related symptoms will be recorded in a daily diary.

Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Drug: echinacea
    drops, 0.9 ml, tid for 4 months
  • Drug: placebo
    drops, 0.9 ml tid for 4 months
  • Experimental: echinacea
    Intervention: Drug: echinacea
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2011
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • On average more than 2 cold episodes per year
  • Age above 18 years
  • Good physical condition
  • Signed informed consent

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
Not Provided
Bioforce AG
Bioforce AG
Not Provided
Not Provided
Bioforce AG
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP