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

This study has been completed.

Sponsor:

Information provided by:

HaEmek Medical Center, Israel

ClinicalTrials.gov Identifier:

NCT00611390

First received: January 8, 2008

Last updated: June 13, 2008

Last verified: June 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

January 8, 2008

Last Updated Date

June 13, 2008

Start Date ^ICMJE

January 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00611390 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Viral Laryngitis
Viral Tracheitis

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: 1
treatment with spray containing aromatic essential oils of some herbal plants.

Intervention: Dietary Supplement: mixture of aromatic essential oils.
Placebo Comparator: 2
spray containing placebo.

Intervention: Dietary Supplement: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00611390

Other Study ID Numbers ^ICMJE

emc070165ctil, Rakover3

Has Data Monitoring Committee

Yes

Responsible Party

Yoseph Rakover, M.D., Head of Department of Otorhinolaryngology, HaEmek Medical Center, Israel

Study Sponsor ^ICMJE

HaEmek Medical Center, Israel

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Yoseph Rakover, M.D.

HaEmek Medical Center

Information Provided By

HaEmek Medical Center, Israel

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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