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

October 6 University

Status and phase: Unknown; Phase 2

Conditions: Recurrent Mouth Ulcers

Treatments: Drug: omega-3; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01831453

Dr. Amr Elkhouli 1962

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 13 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

isopropylmyristate oil

Placebo Comparator group

Description:

placebo Soft gelatinous capsules filled with isopropylmyristate oil

Treatment:

Drug: placebo

experimental

Active Comparator group

Description:

omega-3 1 gram three times daily for 6 months

Treatment:

Drug: omega-3