Therapeutic Effect of Systemic Omega-3 Polyunsaturated Fatty Acids On Quality of Life in Patients Suffering From Recurrent Aphthous Stomatitis Unresponsive to Topical Therapy.
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- quality of life
研究概览
简要总结
The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral aphthous ulcers
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
isopropylmyristate oil
placebo Soft gelatinous capsules filled with isopropylmyristate oil
干预措施: placebo (Drug)
experimental
omega-3 1 gram three times daily for 6 months
干预措施: omega-3 (Drug)
结局指标
主要结局
quality of life
时间窗: six months
Measurement of oral health related quality of life (OHR-QoL),this parameter was carried out at baseline, and at 6 months of the study using the Arabic version of oral health impact profile-14 (OHIP-14) questionnaire.
次要结局
- Pain associated with the ulcers(Six months)
- Duration of ulcers episode(Six months)
- The monthly number of ulcer outbreaks(Monthly for six months)
研究者
Amr Moustafa Elkhouli
Associate professor
October 6 University