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Sponsored by: |
Bioforce AG |
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Information provided by: | Bioforce AG |
ClinicalTrials.gov Identifier: | NCT00707902 |
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 | Intervention | Phase |
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Pharyngitis |
Drug: chlorhexidine/lidocaine Drug: echinacea/sage |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
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 |
Enrollment: | 154 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | August 2006 |
Arms | Assigned Interventions |
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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 |
Drug: echinacea/sage |
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. |
Drug: chlorhexidine/lidocaine |
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
Ages Eligible for Study: | 12 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Bioforce AG, Roggwil, Switzerland ( Andy Suter, Head of Medical Dept. ) |
Study ID Numbers: | 920'073 |
Study First Received: | June 27, 2008 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00707902 |
Health Authority: | Switzerland: Swissmedic |
Sore throats, Pharyngitis Acute |
Chlorhexidine Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Chlorhexidine gluconate |
Lidocaine Stomatognathic Diseases Pharyngitis Pharyngeal Diseases |
Anti-Infective Agents Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Cardiovascular Agents Pharmacologic Actions Anesthetics, Local Anti-Infective Agents, Local |
Disinfectants Sensory System Agents Therapeutic Uses Anti-Arrhythmia Agents Peripheral Nervous System Agents Dermatologic Agents Central Nervous System Agents |