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 - Full Text View

Sponsored by:	Bioforce AG
Information provided by:	Bioforce AG
ClinicalTrials.gov Identifier:	NCT00707902

Purpose

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.

Condition	Intervention	Phase
Pharyngitis	Drug: chlorhexidine/lidocaine Drug: echinacea/sage	Phase III

MedlinePlus related topics: Sore Throat

Drug Information available for: Chlorhexidine Chlorhexidine digluconate Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Bioforce AG:

Primary Outcome Measures:

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. [ Time Frame: first three days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: five days of treatment ] [ Designated as safety issue: Yes ]

Enrollment:	154
Study Start Date:	February 2006
Estimated Study Completion Date:	August 2006

Arms	Assigned Interventions
2: Active Comparator Drug: Echinacea/sage patients received additionally a placebo-spray for the synthetical comparator (chlorhexidine/lidocaine) as the study was double dummy blinded. Patients had to apply spray every 2 hours with two puffs to the pharyngeal area up to a maximum of 10 times daily. Treatment duration was until illness was resolved or for a maximum of 5 consecutive days. Arms: 1	Drug: echinacea/sage
1: Active Comparator Drug: Chlorhexidine/lidocaine patients received additionally a placebo-spray for the synthetical comparator (echinacea/sage) as the study was double dummy blinded. Patients had to apply spray every 2 hours with two puffs to the pharyngeal area up to a maximum of 10 times daily. Treatment duration was until illness was resolved or for a maximum of 5 consecutive days.	Drug: chlorhexidine/lidocaine

Arms

Assigned Interventions

2: Active Comparator

Drug: Echinacea/sage

patients received additionally a placebo-spray for the synthetical comparator (chlorhexidine/lidocaine) as the study was double dummy blinded.

Patients had to apply spray every 2 hours with two puffs to the pharyngeal area up to a maximum of 10 times daily. Treatment duration was until illness was resolved or for a maximum of 5 consecutive days.

Arms: 1

Drug: echinacea/sage

1: Active Comparator

Drug: Chlorhexidine/lidocaine

patients received additionally a placebo-spray for the synthetical comparator (echinacea/sage) as the study was double dummy blinded.

Patients had to apply spray every 2 hours with two puffs to the pharyngeal area up to a maximum of 10 times daily. Treatment duration was until illness was resolved or for a maximum of 5 consecutive days.

Drug: chlorhexidine/lidocaine

Detailed 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

Eligibility

Ages Eligible for Study:	12 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707902

Locations

Switzerland
Allergy Clinic
Landquart, Switzerland, 7302

Sponsors and Collaborators

Bioforce AG

Investigators

Principal Investigator:

Dominique Kähler, MD

General practice, Hubstrasse 37, 9500 Wil, Switzerland

More Information

Publications of Results:

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.

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.

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 Sep-Oct;9(5):68-79.

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. 2006 Jan 31;11(1):20-6.

Responsible Party:	Bioforce AG, Roggwil, Switzerland ( Andy Suter, Head of Medical Dept. )
Study ID Numbers:	920'073
Study First Received:	June 27, 2008
Last Updated:	June 30, 2008
ClinicalTrials.gov Identifier:	NCT00707902
Health Authority:	Switzerland: Swissmedic

Keywords provided by Bioforce AG:

Sore throats,
Pharyngitis
Acute

Study placed in the following topic categories:

Chlorhexidine
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Chlorhexidine gluconate

Lidocaine
Stomatognathic Diseases
Pharyngitis
Pharyngeal Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Cardiovascular Agents
Pharmacologic Actions
Anesthetics, Local
Anti-Infective Agents, Local

Disinfectants
Sensory System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009