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

Rhino-Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610779
• Other study ID #: emc070166ctil
• Secondary ID: Rakover2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 8, 2008
• Last updated: June 13, 2008
• Start date: January 2008
• Est. completion date: May 2008

Study information

• Verified date: June 2008
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhino-Sinusitis
• Sinusitis

Intervention

Dietary Supplement:
• 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.
• placebo
0.1% of Lemon VIP (Florasynth,Israel), spraying to the nose.

Locations

Country	Name	City	State
Israel	Otorhinolaryngology department	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate a relief in the nasal obstruction within the first 20 minutes after first administration of treatment with the spray.		20 minutes	Yes
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.		3 days	Yes