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

June 13, 2008 updated by: HaEmek Medical Center, Israel

Treatment of Acute Pharyngo-Tonsillitis With Essential Oils of Some Aromatic Medical Plants.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 18101
        • Otorhinolaryngology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Yoseph Rakover, M.D., HaEmek Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

January 8, 2008

First Submitted That Met QC Criteria

February 7, 2008

First Posted (Estimate)

February 8, 2008

Study Record Updates

Last Update Posted (Estimate)

June 17, 2008

Last Update Submitted That Met QC Criteria

June 13, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • emc070167ctil
  • Rakover1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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