Viral Laryngitis Clinical Trial
Official title:
Treatment of Acute Tracheitis and Laryngitis With Essential Oils of Some Aromatic Medical Plants.
Verified date | June 2008 |
Source | HaEmek Medical Center, Israel |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ethics Committee |
Study type | Interventional |
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
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Otorhinolaryngology department | Afula |
Lead Sponsor | Collaborator |
---|---|
HaEmek Medical Center, Israel |
Israel,
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 |