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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

Primary Purpose

Pharyngitis

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
chlorhexidine/lidocaine
echinacea/sage
Sponsored by
A. Vogel AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pharyngitis focused on measuring Sore throats,, Pharyngitis, Acute

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Allergy Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

2

1

Arm Description

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: 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.

Outcomes

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.

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

Full Information

First Posted
June 27, 2008
Last Updated
June 30, 2008
Sponsor
A. Vogel AG
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1. Study Identification

Unique Protocol Identification Number
NCT00707902
Brief Title
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

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
A. Vogel AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis
Keywords
Sore throats,, Pharyngitis, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
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
Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
chlorhexidine/lidocaine
Intervention Type
Drug
Intervention Name(s)
echinacea/sage
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Kähler, MD
Organizational Affiliation
General practice, Hubstrasse 37, 9500 Wil, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy Clinic
City
Landquart
ZIP/Postal Code
7302
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
15556647
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.
Results Reference
result
PubMed Identifier
17597571
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. Erratum In: Lancet Infect Dis. 2007 Sep;7(9):580.
Results Reference
result
PubMed Identifier
14526713
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.
Results Reference
result
PubMed Identifier
16504956
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.
Results Reference
result
PubMed Identifier
19748859
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.
Results Reference
derived

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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

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