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

Primary Purpose

Viral Pharyngitis, Viral Tonsillitis

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
mixture of aromatic essential oils.
placebo
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Viral Pharyngitis focused on measuring Viral pharyngo-tonsillitis;, Herbal medicine;, Traditional medicine;, Aromatic essential oils;

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Otorhinolaryngology department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

treatment with spray containing aromatic essential oils of some herbal plants.

spray containing placebo.

Outcomes

Primary Outcome Measures

To demonstrate a throat pain relief within the first 20 minutes after first administration of treatment with the spray.

Secondary Outcome Measures

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.

Full Information

First Posted
January 8, 2008
Last Updated
June 13, 2008
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT00610519
Brief Title
Treatment of Acute Pharyngo-Tonsillitis With Essential Oils of Aromatic Plants
Official Title
Treatment of Acute Pharyngo-Tonsillitis With Essential Oils of Some Aromatic Medical Plants.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Pharyngitis, Viral Tonsillitis
Keywords
Viral pharyngo-tonsillitis;, Herbal medicine;, Traditional medicine;, Aromatic essential oils;

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoseph Rakover, M.D.
Organizational Affiliation
haemek medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Otorhinolaryngology department
City
Afula
ZIP/Postal Code
18101
Country
Israel

12. IPD Sharing Statement

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

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