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Completed

NCT Number: NCT01021995

Echinacea Safety Study

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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Key information

Conditions

Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiff School of Biosciences

Cardiff, Wales, CF103AX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

echinacea

Drug

drops, 0.9 ml, tid for 4 months

Placebo

Drug

drops, 0.9 ml tid for 4 months

Primary outcomes

  1. Occurrence of Adverse Drug Reactions

    Time frame: 4 months

Secondary outcomes

  1. efficacy

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

A. Vogel AG

Industry

Registry information

Official study title

Safety and Efficacy of Long-term Treatment With Echinaforce® Over 4 Months

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Dec 1, 2009
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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