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

Phase 1

Completed

• Conditions: Rhino-Sinusitis
• Interventions: Dietary Supplement: mixture of aromatic essential oils.; Dietary Supplement: placebo

• Registration Number: NCT00610779
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

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

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-02-07
• Study First Posted: 2008-02-08
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-13
• Last Update Posted: 2008-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	mixture of aromatic essential oils.	treatment with spray containing aromatic essential oils of some herbal plants.
2	placebo	spray containing placebo.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Otorhinolaryngology department; 🇮🇱 Afula, Israel