Echinacea Safety Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

757 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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echinacea

Group Type EXPERIMENTAL

echinacea

Intervention Type DRUG

drops, 0.9 ml, tid for 4 months

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

drops, 0.9 ml tid for 4 months

Interventions

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echinacea

drops, 0.9 ml, tid for 4 months

Intervention Type DRUG

placebo

drops, 0.9 ml tid for 4 months

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes