Echinacea Safety Study
Safety and Efficacy of Long-term Treatment With Echinaforce® Over 4 Months
1 other identifier
interventional
757
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 30, 2009
CompletedFirst Posted
Study publicly available on registry
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJuly 23, 2014
June 1, 2011
10 months
November 30, 2009
July 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of Adverse Drug Reactions
4 months
Secondary Outcomes (1)
efficacy
4 months
Study Arms (2)
echinacea
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- On average more than 2 cold episodes per year
- Age above 18 years
- Good physical condition
- Signed informed consent
You may not qualify if:
- Women without appropriate and effective contraception
- Participation in a clinical trial 30 days prior to this trial
- Pregnant or breast feeding women
- Concurrent participation in another clinical trial
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- A. Vogel AGlead
Study Sites (1)
Cardiff School of Biosciences
Cardiff, Wales, CF103AX, United Kingdom
MeSH Terms
Conditions
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2009
First Posted
December 1, 2009
Study Start
October 1, 2009
Primary Completion
August 1, 2010
Study Completion
April 1, 2011
Last Updated
July 23, 2014
Record last verified: 2011-06