Echinacea Safety Study

This study has been completed.
Sponsor:
Information provided by:
Bioforce AG
ClinicalTrials.gov Identifier:
NCT01021995
First received: November 30, 2009
Last updated: June 9, 2011
Last verified: June 2011

November 30, 2009
June 9, 2011
October 2009
August 2010   (final data collection date for primary outcome measure)
Occurrence of Adverse Drug Reactions [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01021995 on ClinicalTrials.gov Archive Site
efficacy [ Time Frame: 4 months ] [ Designated as safety issue: No ]
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Infections
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
750
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)
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01021995
920'134
No
Ronald Eccles / Professor, Common Cold Centre and Healthcare, University Cardiff, UK
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