Clinical Trial for Assessment of Safety and Efficacy of a Echinacea/Sage Spray Compared to a Chlorhexidine/Lidocaine Spray in the Treatment of Acute Sore Throats

Pharyngitis Clinical Trial

Official title:

Multicentric Randomized Double Blind Double Dummy Placebo Controlled Clinical Trial for Assessment of Safety and Efficacy of a Echinacea/Sage Spray in Comparison to a Chlorhexidine/Lidocaine Spray in the Treatment of Acute Sore Throats

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707902
• Other study ID #: 920'073
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2008
• Last updated: June 30, 2008
• Start date: February 2006
• Est. completion date: August 2006

Study information

• Verified date: June 2008
• Source: Bioforce AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to show non-inferiority of an echinacea/sage spray compared to a chlorhexidine/lidocaine-spray in the treatment of acute sore throat during five days of treatment.

Main outcome parameter is the non-inferiority in number of responders between the two treatment groups. A responder is defined as a reduction by 50% of the total baseline score taken prior to treatment start. The symptoms are assessed with a symptom score.

Description:

Further secondary parameters are :

Responders during at day 4 and 5, single symptom scores during 1 to 5 days of observation, pain at begin and end (100mm VAS), assessment of efficacy by physician and patient, consumption of rescue medication

Assessment of safety by physician and patient, frequency of adverse events

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age > 12 years;

• Acute pharyngitis or tonsillitis with symptoms of throat pain and inflammation of the pharynx and/or tonsils;

• Onset of sore throat less than 72 hours before inclusion ;

• A Tonsillopharyngitis Severity Score =6;

• Written informed consent.

Exclusion Criteria:

• Analgesics <12 hours;

• Antibiotics <24 hours; t

• Topical throat pain medication <4 hours;

• Systemic corticosteroids within the last month;

• Symptoms of primary bacterial pharyngitis or secondary bacterial infection;

• Serious illness such as tumors; allergy to one of the ingredients; pregnancy or lactation;

• Hypersensitivity to ibuprofen;

• Participation in another clinical trial in the previous 30 days.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharyngitis

Intervention

Drug:
• chlorhexidine/lidocaine

• echinacea/sage

Locations

Country	Name	City	State
Switzerland	Allergy Clinic	Landquart

Sponsors (1)

Lead Sponsor	Collaborator
Bioforce AG

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

Bereznoy VV, Riley DS, Wassmer G, Heger M. Efficacy of extract of Pelargonium sidoides in children with acute non-group A beta-hemolytic streptococcus tonsillopharyngitis: a randomized, double-blind, placebo-controlled trial. Altern Ther Health Med. 2003 — View Citation

Gertsch J, Schoop R, Kuenzle U, Suter A. Echinacea alkylamides modulate TNF-alpha gene expression via cannabinoid receptor CB2 and multiple signal transduction pathways. FEBS Lett. 2004 Nov 19;577(3):563-9. — View Citation

Hubbert M, Sievers H, Lehnfeld R, Kehrl W. Efficacy and tolerability of a spray with Salvia officinalis in the treatment of acute pharyngitis - a randomised, double-blind, placebo-controlled study with adaptive design and interim analysis. Eur J Med Res. — View Citation

Shah SA, Sander S, White CM, Rinaldi M, Coleman CI. Evaluation of echinacea for the prevention and treatment of the common cold: a meta-analysis. Lancet Infect Dis. 2007 Jul;7(7):473-80. Review. Erratum in: Lancet Infect Dis. 2007 Sep;7(9):580. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of responder of the two treatment groups after the first, second, and third days. A responder is defined as a reduction by 50% of the total baseline score taken prior to treatment start.		first three days of treatment	No
Secondary	Comparison of response rates after 4th and 5th days of treatment; VAS throat pain; amount rescue medication used; global assessment efficacy Frequency of adverse events, global assessment of tolerability		five days of treatment	Yes