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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

January 8, 2008
June 13, 2008
January 2008
May 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00610779 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Treatment of Acute Rhino-Sinusitis With Essential Oils of Aromatic Plants
Treatment of Acute Rhino-Sinusitis With Essential Oils of Some Aromatic Medical Plants.

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

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rhino-Sinusitis
  • 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.
  • Dietary Supplement: placebo
    0.1% of Lemon VIP (Florasynth,Israel), spraying to the nose.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00610779
emc070166ctil, Rakover2
Yes
Yoseph Rakover, M.D., Head of Department of Otorhinolaryngology, HaEmek Medical Center, Israel
HaEmek Medical Center, Israel
Not Provided
Principal Investigator: Yoseph Rakover, M.D. HaEmek Medical Center
HaEmek Medical Center, Israel
June 2008

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