Clinical trial NCT00611390: Treatment of Acute Tracheitis and Laryngitis With Essential Oils of Aromatic Plants
Official title: Treatment of Acute Tracheitis and Laryngitis With Essential Oils of Some Aromatic Medical Plants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Viral Laryngitis
Viral Tracheitis
Keywords: Viral laryngitis;
Viral tracheitis;
Herbal medicine;
Traditional medicine;
Aromatic essential oils;
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: To demonstrate a cough or hoarseness relief within the first 20 minutes after first administration of treatment with the spray.
timeFrame: 20 minutes
Secondary outcomes:
measure: 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.
timeFrame: 3 days
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Otorhinolaryngology department
Study officials:
affiliation: haemek medical center
name: Yoseph Rakover, M.D.
role: PRINCIPAL_INVESTIGATOR
References: