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Completed

NCT Number: NCT00707902

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

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.

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Key information

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Allergy Clinic

Landquart, 7302, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

chlorhexidine/lidocaine

Drug

echinacea/sage

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

A. Vogel AG

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2006
First posted
Jul 1, 2008
Registry last updated
Jul 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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