Treatment of Acute Pharyngo-Tonsillitis With Essential Oils of Aromatic Plants

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This randomized, double blind, parallel group study, compared the efficacy of spray containing aromatic essential oils of some herbal plants, against placebo in the treatment of patients with acute viral Pharyngo-tonsillitis.

Study objectives: Primary to demonstrate a throat pain relief within 20 minutes after first administration of treatment with the spray.

Secondary to demonstrate a reduction of a defined symptoms sum score based on symptoms and signs comparing baseline therapy from the beginning to the end of 3 days treatment

Condition or disease	Intervention/treatment	Phase
Viral Pharyngitis; Viral Tonsillitis	Dietary Supplement: mixture of aromatic essential oils.; Dietary Supplement: placebo	Phase 1; Phase 2

Detailed Description:

This study compared the efficacy of spray containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, against placebo in the treatment of patients with acute viral Pharyngo-tonsillitis.

In- vitro and clinical studies suggest therapeutic potential of aromatic herbs and trees oils in the treatment of Pharyngo-Tonsillitis. The pharmacological and clinical activity of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, include anti-inflammatory, anti-bacterial and anti-viral activities. Some of these herbs and trees oils have direct activity on the respiratory tract, the coughing reflex and the airflow in the nasal tract.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	33 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Treatment of Acute Pharyngo-Tonsillitis With Essential Oils of Some Aromatic Medical Plants.
Study Start Date :	January 2008
Actual Primary Completion Date :	May 2008
Actual Study Completion Date :	May 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: 1; treatment with spray containing aromatic essential oils of some herbal plants.	Dietary Supplement: mixture of aromatic essential oils.; 3% of mixture containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, spraying to the throat.
Placebo Comparator: 2; spray containing placebo.	Dietary Supplement: placebo; 0:1% of Lemon VIP (Florasynth,Israel), spraying to the throat.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. To demonstrate a throat pain relief within the first 20 minutes after first administration of treatment with the spray. [ Time Frame: 20 minutes ]

Secondary Outcome Measures :

1. To demonstrate a reduction of a defined symptoms sum score based on symptoms and signs comparing baseline therapy from the beginning to the end of 3 days treatment. [ Time Frame: 3 days ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Clinical diagnosis of acute viral pharyngo-tonsillitis.
• Active disease less than 48 hours
• Patients agree to sign informed consent according to GCP and Israel national regulations.

Exclusion Criteria:

• Acute follicular tonsillitis.
• Peritonsillar abscess.
• Under any antibiotically treatment.
• Asthma disease.
• Under coumadine therapy.
• Hyper sensitivity to Aromatic essential oils.
• Any immuno-suppressive disease

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Israel
Otorhinolaryngology department
Afula, Israel, 18101

Sponsors and Collaborators

HaEmek Medical Center, Israel

Investigators

Principal Investigator:	Yoseph Rakover, M.D.	haemek medical center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Yoseph Rakover, M.D., Head of Department of Otorhinolaryngology, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT00610519 History of Changes
Other Study ID Numbers:	emc070167ctil; Rakover1
First Posted:	February 8, 2008
Last Update Posted:	June 17, 2008
Last Verified:	June 2008

Keywords provided by HaEmek Medical Center, Israel:

Viral pharyngo-tonsillitis; Herbal medicine; Traditional medicine; Aromatic essential oils;

Additional relevant MeSH terms:

Pharyngitis; Tonsillitis; Pharyngeal Diseases; Stomatognathic Diseases	Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases