Treatment of Acute Pharyngo-Tonsillitis With Essential Oils of Aromatic Plants - Full Text View

Purpose

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 Pharyngo-tonsillitis.

Study objectives: Primary to demonstrate a throat pain 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

Condition	Intervention	Phase
Viral Pharyngitis Viral Tonsillitis	Dietary Supplement: mixture of aromatic essential oils. Dietary Supplement: placebo	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
Official Title:	Treatment of Acute Pharyngo-Tonsillitis With Essential Oils of Some Aromatic Medical Plants.

Resource links provided by NLM:

MedlinePlus related topics: Tonsillitis

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:

To demonstrate a throat pain relief within the first 20 minutes after first administration of treatment with the spray. [ Time Frame: 20 minutes ]

Secondary Outcome Measures:

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 ]


Enrollment:	33
Study Start Date:	January 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 treatment with spray containing aromatic essential oils of some herbal plants.	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 throat.
Placebo Comparator: 2 spray containing placebo.	Dietary Supplement: placebo 0:1% of Lemon VIP (Florasynth,Israel), spraying to the throat.

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 Pharyngo-tonsillitis.

In- vitro and clinical studies suggest therapeutic potential of aromatic herbs and trees oils in the treatment of Pharyngo-Tonsillitis. 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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of acute viral pharyngo-tonsillitis.
Active disease less than 48 hours
Patients agree to sign informed consent according to GCP and Israel national regulations.

Exclusion Criteria:

Acute follicular tonsillitis.
Peritonsillar abscess.
Under any antibiotically treatment.
Asthma disease.
Under coumadine therapy.
Hyper sensitivity to Aromatic essential oils.
Any immuno-suppressive disease

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610519

Locations


Israel
Otorhinolaryngology department
Afula, Israel, 18101

Sponsors and Collaborators

HaEmek Medical Center, Israel

Investigators


Principal Investigator:	Yoseph Rakover, M.D.	haemek medical center

More Information


Responsible Party:	Yoseph Rakover, M.D., Head of Department of Otorhinolaryngology, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT00610519 History of Changes
Other Study ID Numbers:	emc070167ctil Rakover1
Study First Received:	January 8, 2008
Last Updated:	June 13, 2008

Keywords provided by HaEmek Medical Center, Israel:


Viral pharyngo-tonsillitis; Herbal medicine; Traditional medicine; Aromatic essential oils;

Additional relevant MeSH terms:


Pharyngitis Tonsillitis Pharyngeal Diseases Stomatognathic Diseases	Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 23, 2017