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

This study has been completed.
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00610779
First received: January 8, 2008
Last updated: June 13, 2008
Last verified: June 2008
History of Changes
  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 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 Intervention Phase
Rhino-Sinusitis
 Dietary Supplement: mixture of aromatic essential oils.
Dietary Supplement: placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Acute Rhino-Sinusitis With Essential Oils of Some Aromatic Medical Plants.

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ] [ 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: 14
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
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.

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.

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 8, 2008
Last Updated: June 13, 2008
Health Authority: Israel: Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013