Treatment of Acute Tracheitis and Laryngitis With Essential Oils of Aromatic Plants - Full Text View

Purpose

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

Condition	Intervention	Phase
Viral Laryngitis Viral Tracheitis	Dietary Supplement: mixture of aromatic essential oils. Dietary Supplement: placebo	Phase I Phase II

MedlinePlus related topics:

Cough Dietary Supplements

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:

To demonstrate a cough or hoarseness relief within the first 20 minutes after first administration of treatment with the spray. [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Enrollment:	29
Study Start Date:	January 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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 larynx.
2: Placebo Comparator spray containing placebo.	Dietary Supplement: placebo 0.1% of Lemon VIP (Florasynth,Israel), spraying to the larynx.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611390

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

Responsible Party:	HaEmek Medical Center, Israel ( Yoseph Rakover, M.D., Head of Department of Otorhinolaryngology )
Study ID Numbers:	emc070165ctil, Rakover3
First Received:	January 8, 2008
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00611390
Health Authority:	Israel: Ethics Committee