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

A. Vogel AG

Status and phase: Completed; Phase 3

Conditions: Pharyngitis

Treatments: Drug: chlorhexidine/lidocaine; Drug: echinacea/sage

Study type: Interventional

Funder types: Industry

Identifiers

NCT00707902

920'073

Details and patient eligibility

About

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.

Full 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

Enrollment: 154 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups

2

Active Comparator group

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

Treatment:

Drug: echinacea/sage

1

Active Comparator group

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.

Treatment:

Drug: chlorhexidine/lidocaine