- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00610779
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
Study Overview
Status
Conditions
Intervention / 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 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
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
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Afula, Israel, 18101
- Otorhinolaryngology department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
treatment with spray containing aromatic essential oils of some herbal plants.
|
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.
|
0.1% of Lemon VIP (Florasynth,Israel), spraying to the nose.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yoseph Rakover, M.D., HaEmek Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- emc070166ctil
- Rakover2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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