Echinacea Safety Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bioforce AG
ClinicalTrials.gov Identifier:
NCT01021995
First received: November 30, 2009
Last updated: July 22, 2014
Last verified: June 2011
  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:


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 ]

Enrollment: 757
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Bioforce AG
ClinicalTrials.gov Identifier: NCT01021995     History of Changes
Other Study ID Numbers: 920'134
Study First Received: November 30, 2009
Last Updated: July 22, 2014
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 October 29, 2014