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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00611390
Other study ID # emc070165ctil
Secondary ID Rakover3
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 viral Laryngitis or Tracheitis.

Study objectives: Primary to demonstrate a hoarseness or cough relief 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 viral Laryngitis or Tracheitis.

In- vitro and clinical studies suggest therapeutic potential of aromatic herbs and trees oils in the treatment of Laryngitis or Tracheitis. 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 29
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 viral Laryngitis or viral tracheitis.

- Active disease less than 48 hours

- Patients agree to sign informed consent according to GCP and Israel national regulations.

Exclusion Criteria:

- Acute lower respiratory tract infection.

- C.O.P.D.(Chronic Obstructive Pulmonary Disease)

- 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


Intervention

Dietary Supplement:
mixture of aromatic essential oils.
3% of mixture containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, spraying to the larynx.
placebo
0.1% of Lemon VIP (Florasynth,Israel), spraying to the larynx.

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 cough or hoarseness relief 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