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Treatment of Acute Tracheitis and Laryngitis With Essential Oils of Aromatic Plants

NCT ID: NCT00611390

Last Updated: 2008-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-05-31

Brief Summary

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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 Laryngitis or Tracheitis.

Study objectives: Primary to demonstrate a hoarseness or cough 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

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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 Laryngitis or Tracheitis.

In- vitro and clinical studies suggest therapeutic potential of aromatic herbs and trees oils in the treatment of Laryngitis or Tracheitis. 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.

Conditions

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Viral Laryngitis Viral Tracheitis

Keywords

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Viral laryngitis; Viral tracheitis; Herbal medicine; Traditional medicine; Aromatic essential oils;

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

mixture of aromatic essential oils.

Intervention Type DIETARY_SUPPLEMENT

3% of mixture containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, spraying to the larynx.

2

spray containing placebo.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

0.1% of Lemon VIP (Florasynth,Israel), spraying to the larynx.

Interventions

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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 larynx.

Intervention Type DIETARY_SUPPLEMENT

placebo

0.1% of Lemon VIP (Florasynth,Israel), spraying to the larynx.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of acute viral Laryngitis or viral tracheitis.
* Active disease less than 48 hours
* Patients agree to sign informed consent according to GCP and Israel national regulations.

Exclusion Criteria

* Acute lower respiratory tract infection.
* C.O.P.D.(Chronic Obstructive Pulmonary Disease)
* Under any antibiotically treatment.
* Asthma disease.
* Under coumadine therapy.
* Hyper sensitivity to Aromatic essential oils.
* Any immuno-suppressive disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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HaEmek Medical Center, Israel

Principal Investigators

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Yoseph Rakover, M.D.

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Locations

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Otorhinolaryngology department

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Rakover3

Identifier Type: -

Identifier Source: secondary_id

emc070165ctil

Identifier Type: -

Identifier Source: org_study_id