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

June 30, 2008 updated by: A. Vogel AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

154

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Landquart, Switzerland, 7302
        • Allergy Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Drug: chlorhexidine/lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
first three days of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
five days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A. Vogel AG

Investigators

  • Principal Investigator: Dominique Kähler, MD, General practice, Hubstrasse 37, 9500 Wil, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion

August 1, 2006

Study Registration Dates

First Submitted

June 27, 2008

First Submitted That Met QC Criteria

June 30, 2008

First Posted (Estimate)

July 1, 2008

Study Record Updates

Last Update Posted (Estimate)

July 1, 2008

Last Update Submitted That Met QC Criteria

June 30, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 920'073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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