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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 30, 2009
Last Updated Date	June 9, 2011
Start Date ^ICMJE	October 2009
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 30, 2009)	Occurrence of Adverse Drug Reactions [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01021995 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 30, 2009)	efficacy [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Echinacea Safety Study
Official Title ^ICMJE	Safety and Efficacy of Long-term Treatment With Echinaforce® Over 4 Months
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Infections
Intervention ^ICMJE	Drug: echinacea drops, 0.9 ml, tid for 4 months Drug: placebo drops, 0.9 ml tid for 4 months
Study Arm (s)	Experimental: echinacea Intervention: Drug: echinacea Placebo Comparator: placebo Intervention: Drug: placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	750
Completion Date	April 2011
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01021995
Other Study ID Numbers ^ICMJE	920'134
Has Data Monitoring Committee	No
Responsible Party	Ronald Eccles / Professor, Common Cold Centre and Healthcare, University Cardiff, UK
Study Sponsor ^ICMJE	Bioforce AG
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bioforce AG
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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