Trial | NCT00707902  Report issue

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
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    154
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.
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 Started
Feb 28
2006
Study Completion
Aug 31
2006
Last Update
Jul 01
2008
Estimate

Drug chlorhexidine/lidocaine

Drug echinacea/sage

2 Active Comparator

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

1 Active Comparator

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.

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.
No Results Posted