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

HaEmek Medical Center, Israel

Status and phase: Completed; Phase 2; Phase 1

Conditions: Rhino-Sinusitis

Treatments: Dietary Supplement: placebo; Dietary Supplement: mixture of aromatic essential oils.

Study type: Interventional

Funder types: Other

Identifiers

NCT00610779

Rakover2

emc070166ctil

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: mixture of aromatic essential oils.

2

Placebo Comparator group

Description:

spray containing placebo.

Treatment:

Dietary Supplement: placebo