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
NCT ID: NCT00707902
Last Updated: 2008-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
154 participants
INTERVENTIONAL
2006-02-28
2006-08-31
Brief Summary
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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.
Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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2
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
echinacea/sage
1
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.
chlorhexidine/lidocaine
Interventions
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chlorhexidine/lidocaine
echinacea/sage
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
75 Years
ALL
No
Sponsors
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A. Vogel AG
INDUSTRY
Responsible Party
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Bioforce AG, Roggwil, Switzerland
Principal Investigators
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Dominique Kähler, MD
Role: PRINCIPAL_INVESTIGATOR
General practice, Hubstrasse 37, 9500 Wil, Switzerland
Locations
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Allergy Clinic
Landquart, , Switzerland
Countries
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References
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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. doi: 10.1016/j.febslet.2004.10.064.
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. doi: 10.1016/S1473-3099(07)70160-3.
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.
Schapowal A, Berger D, Klein P, Suter A. Echinacea/sage or chlorhexidine/lidocaine for treating acute sore throats: a randomized double-blind trial. Eur J Med Res. 2009 Sep 1;14(9):406-12. doi: 10.1186/2047-783x-14-9-406.
Other Identifiers
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920'073
Identifier Type: -
Identifier Source: org_study_id