Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 27 for:    Echinacea

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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00707902
Recruitment Status : Completed
First Posted : July 1, 2008
Last Update Posted : July 1, 2008
Sponsor:
Information provided by:
Bioforce AG

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : February 2006
Study Completion Date : August 2006


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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707902


Locations
Layout table for location information
Switzerland
Allergy Clinic
Landquart, Switzerland, 7302
Sponsors and Collaborators
Bioforce AG
Investigators
Layout table for investigator information
Principal Investigator: Dominique Kähler, MD General practice, Hubstrasse 37, 9500 Wil, Switzerland

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Andy Suter, Head of Medical Dept., Bioforce AG, Roggwil, Switzerland
ClinicalTrials.gov Identifier: NCT00707902     History of Changes
Other Study ID Numbers: 920'073
First Posted: July 1, 2008    Key Record Dates
Last Update Posted: July 1, 2008
Last Verified: June 2008

Keywords provided by Bioforce AG:
Sore throats,
Pharyngitis
Acute

Additional relevant MeSH terms:
Layout table for MeSH terms
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Chlorhexidine
Chlorhexidine gluconate
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents