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Trial record 6 of 53 for:    essential oils

Treatment of Acute Rhino-Sinusitis With Essential Oils of Aromatic Plants

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ClinicalTrials.gov Identifier: NCT00610779
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : June 17, 2008
Sponsor:
Information provided by:
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 Rhino-sinusitis.

Study objectives: Primary to demonstrate a relief in the nasal obstruction 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
Rhino-Sinusitis 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 Rhino-sinusitis.

In- vitro and clinical studies suggest therapeutic potential of aromatic herbs and trees oils in the treatment of Rhino-sinusitis. 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 : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Acute Rhino-Sinusitis 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: Sinusitis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
treatment with spray containing aromatic essential oils of some herbal plants.
Dietary Supplement: mixture of aromatic essential oils.
1% of mixture containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, spraying to the nose.
Placebo Comparator: 2
spray containing placebo.
Dietary Supplement: placebo
0.1% of Lemon VIP (Florasynth,Israel), spraying to the nose.



Primary Outcome Measures :
  1. To demonstrate a relief in the nasal obstruction 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of acute Rhino-sinusitis.
  • Active disease less than 96 hours
  • Patients agree to sign informed consent according to GCP and Israel national regulations.

Exclusion Criteria:

  • Acute Sinusitis that need to get an antibiotically treatment .
  • Nasal polyposis.
  • Under any antibiotically treatment.
  • Asthma disease.
  • Under coumadine therapy.
  • Hyper sensitivity to Aromatic essential oils.
  • Any immuno-suppressive disease

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): NCT00610779


Locations
Israel
Otorhinolaryngology department
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Yoseph Rakover, M.D. haemek medical center

Responsible Party: Yoseph Rakover, M.D., Head of Department of Otorhinolaryngology, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00610779     History of Changes
Other Study ID Numbers: emc070166ctil
Rakover2
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:
Rhino-sinusitis;
Herbal medicine;
Traditional medicine;
Aromatic essential oils;

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases