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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00611390
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : June 17, 2008
Sponsor:
Information provided by:
HaEmek Medical Center, Israel

Study Description
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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


Condition or disease Intervention/treatment Phase
Viral Laryngitis Viral Tracheitis Dietary Supplement: mixture of aromatic essential oils. Dietary Supplement: placebo Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Acute Tracheitis and Laryngitis With Essential Oils of Some Aromatic Medical Plants.
Study Start Date : January 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Croup

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


Outcome Measures
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Primary Outcome Measures :
  1. To demonstrate a cough or hoarseness relief within the first 20 minutes after first administration of treatment with the spray. [ Time Frame: 20 minutes ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611390


Locations
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Israel
Otorhinolaryngology department
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Principal Investigator: Yoseph Rakover, M.D. haemek medical center
More Information
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Responsible Party: Yoseph Rakover, M.D., Head of Department of Otorhinolaryngology, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00611390    
Other Study ID Numbers: emc070165ctil
Rakover3
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008
Keywords provided by HaEmek Medical Center, Israel:
Viral laryngitis;
Viral tracheitis;
Herbal medicine;
Traditional medicine;
Aromatic essential oils;
Additional relevant MeSH terms:
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Laryngitis
Tracheitis
Croup
Respiratory Tract Infections
Infections
 Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Tracheal Diseases