Omega-3 and Quality of Life in Recurrent Aphthous Stomatitis Patients

• Status: Unknown status
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: October 6 University
• Collaborator: Tanta University

Criteria

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.