Echinacea Safety Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Infections	Drug: echinacea Drug: placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Safety and Efficacy of Long-term Treatment With Echinaforce® Over 4 Months

Resource links provided by NLM:

Drug Information available for: Echinacea

U.S. FDA Resources

Further study details as provided by Bioforce AG:

Primary Outcome Measures:

Occurrence of Adverse Drug Reactions [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

efficacy [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	750
Study Start Date:	October 2009
Study Completion Date:	April 2011
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: echinacea	Drug: echinacea drops, 0.9 ml, tid for 4 months
Placebo Comparator: placebo	Drug: placebo drops, 0.9 ml tid for 4 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021995

Locations

United Kingdom
Cardiff School of Biosciences
Cardiff, Wales, United Kingdom, CF103AX

Sponsors and Collaborators

Bioforce AG

More Information

No publications provided

Responsible Party:	Ronald Eccles / Professor, Common Cold Centre and Healthcare, University Cardiff, UK
ClinicalTrials.gov Identifier:	NCT01021995 History of Changes
Other Study ID Numbers:	920'134
Study First Received:	November 30, 2009
Last Updated:	June 9, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bioforce AG:

Safety of Echinacea in comparison to placebo

ClinicalTrials.gov processed this record on May 21, 2013