Echinacea Safety Study

Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021995
• Other study ID #: 920'134
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2009
• Last updated: July 22, 2014
• Start date: October 2009
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: Bioforce AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 757
• Est. completion date: April 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infections

Intervention

Drug:
• echinacea
drops, 0.9 ml, tid for 4 months
• placebo
drops, 0.9 ml tid for 4 months

Locations

Country	Name	City	State
United Kingdom	Cardiff School of Biosciences	Cardiff	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Bioforce AG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Adverse Drug Reactions		4 months	Yes
Secondary	efficacy		4 months	No