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

NCT00610779 | Completed Phase 1 DMC

• 2 other identifiers: emc070166ctilRakover2
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Rhino-Sinusitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To demonstrate a relief in the nasal obstruction within the first 20 minutes after first administration of treatment with the spray.

  20 minutes

Secondary Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

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

Dietary Supplement: mixture of aromatic essential oils.

2

PLACEBO COMPARATOR

spray containing placebo.

Dietary Supplement: placebo

Interventions

mixture of aromatic essential oils. 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.

1

placebo DIETARY_SUPPLEMENT

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Otorhinolaryngology department

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Yoseph Rakover, M.D.

  haemek medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: February 8, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 17, 2008

Record last verified: 2008-06

Locations

IL (1)