Status:
UNKNOWN
Omega-3 and Quality of Life in Recurrent Aphthous Stomatitis Patients
Lead Sponsor:
October 6 University
Collaborating Sponsors:
Tanta University
Conditions:
Recurrent Mouth Ulcers
Eligibility:
All Genders
13-70 years
Phase:
PHASE2
Brief Summary
The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral aphthous ulcers
Detailed 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 additi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01831453
Start Date
April 1 2012
End Date
May 1 2013
Last Update
April 15 2013
Active Locations (1)
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1
October 6 university
Cairo, Governarate of 6 of October, Egypt, 11348