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

NCT00707902 | Completed Phase 3 DMC

• 1 other identifier: 920'073
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharyngitis

Keywords

Sore throats,; Pharyngitis; Acute

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

chlorhexidine/lidocaine DRUG

1

echinacea/sage DRUG

2

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 12 years;
• Acute pharyngitis or tonsillitis with symptoms of throat pain and inflammation of the pharynx and/or tonsils;
• A Tonsillopharyngitis Severity Score ≥6;
• Written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• A. Vogel AG: lead

Study Sites (1)

Allergy Clinic

Landquart, 7302, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 15556647 RESULT

• 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.

  PMID: 17597571 RESULT

• 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.

  PMID: 14526713 RESULT

• 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.

  PMID: 16504956 RESULT

• 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.

  PMID: 19748859 DERIVED

MeSH Terms

Conditions

Pharyngitis

Interventions

chlorhexidine gluconate, lidocaine drug combination

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Dominique Kähler, MD

  General practice, Hubstrasse 37, 9500 Wil, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 1, 2008
• Study Start: February 1, 2006
• Study Completion: August 1, 2006
• Last Updated: July 1, 2008

Record last verified: 2008-06

Locations

CH (1)