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Echinacea Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01021995
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Bioforce AG

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.


Condition or disease Intervention/treatment Phase
Infections Drug: echinacea Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 757 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Long-term Treatment With Echinaforce® Over 4 Months
Study Start Date : October 2009
Primary Completion Date : August 2010
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Echinacea
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Occurrence of Adverse Drug Reactions [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. efficacy [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021995


Locations
United Kingdom
Cardiff School of Biosciences
Cardiff, Wales, United Kingdom, CF103AX
Sponsors and Collaborators
Bioforce AG

Responsible Party: Bioforce AG
ClinicalTrials.gov Identifier: NCT01021995     History of Changes
Other Study ID Numbers: 920'134
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: June 2011

Keywords provided by Bioforce AG:
Safety of Echinacea in comparison to placebo