This trial is active, not recruiting.

Condition recurrent mouth ulcers
Treatments omega-3, placebo
Phase phase 2
Sponsor October 6 University
Collaborator Tanta University
Start date April 2012
End date April 2013
Trial size 50 participants
Trial identifier NCT01831453, Dr. Amr Elkhouli 1962


The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral aphthous ulcers

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
placebo Soft gelatinous capsules filled with isopropylmyristate oil
placebo isopropylmyristate oil
soft gelatinous capsules filled with isopropylmyristate oil
(Active Comparator)
omega-3 1 gram three times daily for 6 months
omega-3 fish oil
polyunsaturated fatty acids(PUFAs) 1 gram three times per day for 6 months

Primary Outcomes

quality of life
time frame: six months

Secondary Outcomes

Pain associated with the ulcers
time frame: Six months
Duration of ulcers episode
time frame: Six months
The monthly number of ulcer outbreaks
time frame: Monthly for six months

Eligibility Criteria

Male or female participants from 13 years up to 70 years old.

Inclusion Criteria: 1. Male and female patients older than 13 years of age 2. Presenting with 1 to 3 aphthous ulcers (less than 48 hours' duration) with a size no greater than 5mm in diameter. 3. History of recurrent minor aphthous ulcer for at least one year with a frequency of at least one outbreak every one month. 4. Normal sense of pain, without anesthesia or paresthesia. 5. 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.

Additional Information

Official title Therapeutic Effect of Systemic Omega-3 Polyunsaturated Fatty Acids On Quality of Life in Patients Suffering From Recurrent Aphthous Stomatitis Unresponsive to Topical Therapy.
Principal investigator Amr M Elkhouli, ass prof
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by October 6 University.