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

NCT ID: NCT00610779

Last Updated: 2008-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-05-31

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.

Conditions

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Rhino-Sinusitis

Keywords

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Rhino-sinusitis; Herbal medicine; Traditional medicine; Aromatic essential oils;

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

treatment with spray containing aromatic essential oils of some herbal plants.

Group Type ACTIVE_COMPARATOR

mixture of aromatic essential oils.

Intervention Type DIETARY_SUPPLEMENT

1% of mixture containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, spraying to the nose.

2

spray containing placebo.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

0.1% of Lemon VIP (Florasynth,Israel), spraying to the nose.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

placebo

0.1% of Lemon VIP (Florasynth,Israel), spraying to the nose.

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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HaEmek Medical Center, Israel

Principal Investigators

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Yoseph Rakover, M.D.

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Locations

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Otorhinolaryngology department

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Rakover2

Identifier Type: -

Identifier Source: secondary_id

emc070166ctil

Identifier Type: -

Identifier Source: org_study_id