Completed

NCT Number: NCT00611390

Treatment of Acute Tracheitis and Laryngitis With Essential Oils of Aromatic Plants

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

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Key information

Conditions

Viral Laryngitis Viral Tracheitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Otorhinolaryngology department

Afula, 18101, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mixture of aromatic essential oils.

Dietary Supplement

3% of mixture containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, spraying to the larynx.

Placebo

Dietary Supplement

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

Primary outcomes

To demonstrate a cough or hoarseness relief within the first 20 minutes after first administration of treatment with the spray.

Time frame: 20 minutes

Secondary outcomes

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.

Time frame: 3 days

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

Treatment of Acute Tracheitis and Laryngitis With Essential Oils of Some Aromatic Medical Plants.

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Feb 8, 2008
Registry last updated: Jun 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.