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

Treatment of Acute Tracheitis and Laryngitis With Essential Oils of Some Aromatic Medical Plants.

Sponsors

Lead Sponsor: HaEmek Medical Center, Israel

Source HaEmek Medical Center, Israel
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 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

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.

Overall Status Completed
Start Date 2008-01-01
Completion Date 2008-05-01
Primary Completion Date 2008-05-01
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
To demonstrate a cough or hoarseness relief within the first 20 minutes after first administration of treatment with the spray. 20 minutes
Secondary 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. 3 days
Enrollment 29
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: mixture of aromatic essential oils.

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

Arm Group Label: 1

Intervention Type: Dietary Supplement

Intervention Name: placebo

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

Arm Group Label: 2

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Yoseph Rakover, M.D. Principal Investigator haemek medical center
Location
Facility: Otorhinolaryngology department
Location Countries

Israel

Verification Date

2008-06-01

Responsible Party

Name Title: Yoseph Rakover, M.D., Head of Department of Otorhinolaryngology

Organization: HaEmek Medical Center, Israel

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Active Comparator

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

Label: 2

Type: Placebo Comparator

Description: spray containing placebo.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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