Suspended

Therapeutic Effect of Systemic Omega-3 Polyunsaturated Fatty Acids On Quality of Life in Patients Suffering From Recurrent Aphthous Stomatitis Unresponsive to Topical Therapy.

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What is being tested

placebo

+ omega-3

Drug
Who is being recruted

Stomatognathic Diseases+1

+ Mouth Diseases

+ Stomatitis

From 13 to 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: April 2012
See protocol details

Summary

Principal SponsorOctober 6 University
Last updated: April 15, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2012

Actual date on which the first participant was enrolled.

In this study, we tested the hypothesis that the administration of omega 3 improve the quality of life in patients suffering recurrent oral ulceration and improve associated symptoms of pain in addition to reduction of ulcers episode.

Principal SponsorOctober 6 University
Last updated: April 15, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 13 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Stomatognathic DiseasesMouth DiseasesStomatitisStomatitis, Aphthous

Criteria

Inclusion Criteria: Male and female patients older than 13 years of age Presenting with 1 to 3 aphthous ulcers (less than 48 hours' duration) with a size no greater than 5mm in diameter. History of recurrent minor aphthous ulcer for at least one year with a frequency of at least one outbreak every one month. Normal sense of pain, without anesthesia or paresthesia. Willingness to participate and sign the informed consent. Exclusion Criteria: 1- Concurrent clinical conditions that could pose a health risk to the subjects including serious heart, liver, or kidney dysfunctions. 2- Pregnancy and lactation. 3- Ulcers as a manifestation of systemic disorders such as Ulcerative Colitis, Crohn's disease, Behçet's syndrome or serious anemia. 4- Treatment with systemic steroids, immunomodulatory agents, antibiotics, non-steroidal anti-inflammatory drugs (except occasional use for headaches) one month prior to the study entry. 5- Treatment of the current ulcer with any topical or systemic medication. 6- Attendance of any other clinical trials prior to 3 months of study entry.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
placebo Soft gelatinous capsules filled with isopropylmyristate oil

Group II

Active Comparator
omega-3 1 gram three times daily for 6 months

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

October 6 university

Cairo, EgyptOpen October 6 university in Google Maps
SuspendedOne Study Center