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

Sponsor

A. Vogel AG (Industry)

Overall Status

Completed

CT.gov ID

NCT00707902

Collaborator

(none)

154

Enrollment

Location

Arms

5.9

Duration (Months)

25.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pharyngitis	Drug: chlorhexidine/lidocaine Drug: echinacea/sage	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

154 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2006

Study Completion Date :

Aug 1, 2006

Arms and Interventions

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

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

Outcome Measures

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. [first three days of treatment]

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 [five days of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.