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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Treatment of Acute Rhino-Sinusitis With Essential Oils of Some Aromatic Medical Plants.

Conditions
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Rhino-Sinusitis

Intervention / Treatment
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* Dietary Supplement: mixture of aromatic essential oils.
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate a relief in the nasal obstruction within the first 20 minutes after first administration of treatment with the spray. |  | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhino-sinusitis;, Herbal medicine;, Traditional medicine;, Aromatic essential oils;