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.

Study Overview

• Status: Completed
• Conditions: Infections
• Intervention / Treatment: Drug: echinacea; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 757
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo	Drug: placebo; drops, 0.9 ml tid for 4 months
EXPERIMENTAL: echinacea	Drug: echinacea; drops, 0.9 ml, tid for 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of Adverse Drug Reactions	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
efficacy	4 months

Collaborators and Investigators

• Sponsor: A. Vogel AG

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): April 1, 2011

Study Registration Dates

• First Submitted: November 30, 2009
• First Submitted That Met QC Criteria: November 30, 2009
• First Posted (ESTIMATE): December 1, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 23, 2014
• Last Update Submitted That Met QC Criteria: July 22, 2014
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Safety of Echinacea in comparison to placebo
• Other Study ID Numbers: 920'134