A Phase 1/2 interventional study of mixture of aromatic essential oils. and placebo in Viral Laryngitis and Viral Tracheitis, sponsored by HaEmek Medical Center, Israel. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-06-17.
Sponsored by HaEmek Medical Center, Israel · Phase 1/2, Interventional, and Treatment
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
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.
14 studies on the registry are indexed under Laryngitis; 2 are open to participants now.
This study's enrollment of 29 is below the median of 118 across 11 interventional studies indexed under Laryngitis.
Browse Laryngitis studies →HaEmek Medical Center, Israel is the lead sponsor of 237 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
treatment with spray containing aromatic essential oils of some herbal plants.
Dietary Supplement: mixture of aromatic essential oils.
spray containing placebo.
Dietary Supplement: placebo
3% of mixture containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, spraying to the larynx.
0.1% of Lemon VIP (Florasynth,Israel), spraying to the larynx.
To demonstrate a cough or hoarseness relief within the first 20 minutes after first administration of treatment with the spray.
Time frame: 20 minutes
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
The record gives a start of Jan 2008, a primary completion of May 2008 and a completion of May 2008. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
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HaEmek Medical Center, Israel →