Clinical trial NCT00707902: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pharyngitis
Keywords: Sore throats,
Pharyngitis
Acute
Lead sponsor: A. Vogel AG
Sponsor class: INDUSTRY
First posted: 2008-07-01
Enrollment: 154
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: first three days of treatment
Secondary outcomes:
measure: 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
timeFrame: five days of treatment
Other outcomes:
Locations:
city: Landquart
country: Switzerland
facility: Allergy Clinic
Study officials:
affiliation: General practice, Hubstrasse 37, 9500 Wil, Switzerland
name: Dominique Kähler, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.febslet.2004.10.064.
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. doi: 10.1016/S1473-3099(07)70160-3.
citation: 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.
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. 2006 Jan 31;11(1):20-6.
citation: 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.