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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00707902
Recruitment Status : Completed
First Posted : July 1, 2008
Last Update Posted : July 1, 2008
Sponsor:
Information provided by:
Bioforce AG

Tracking Information
First Submitted Date  ICMJE June 27, 2008
First Posted Date  ICMJE July 1, 2008
Last Update Posted Date July 1, 2008
Study Start Date  ICMJE February 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pharyngitis
Intervention  ICMJE
  • Drug: chlorhexidine/lidocaine
  • Drug: echinacea/sage
Study Arms  ICMJE
  • Active Comparator: 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

    Intervention: Drug: echinacea/sage
  • Active Comparator: 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.

    Intervention: Drug: chlorhexidine/lidocaine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2008)
154
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00707902
Other Study ID Numbers  ICMJE 920'073
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andy Suter, Head of Medical Dept., Bioforce AG, Roggwil, Switzerland
Study Sponsor  ICMJE Bioforce AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dominique Kähler, MD General practice, Hubstrasse 37, 9500 Wil, Switzerland
PRS Account Bioforce AG
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP