The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus and Improvement of Quality of Life: A Randomized, Double Blind, Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improve quality of the life (Oral Health Impact Profile)
研究概览
简要总结
This study was initiated to evaluate the potential of dietary supplementation of omega-3 for providing an inexpensive, safe and effective therapeutic agent for managing atrophic/erosive lichen planus.
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, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of OLP (Presence of painful and atrophic-erosive oral Lesions, bilateral, mostly symmetrical lesions, presence of lace-like network of slightly raised white lines).
- •Age between 30-60 years
- •Ability to complete the present clinical trial.
排除标准
- •Pregnant or breast feeding women (pregnancy test for women of child bearing age).
- •Lichenoid reactions caused by certain drugs or dental amalgam.
- •Therapy for oral lichen planus (OLP) in the 6 months prior to the study.
- •Patient doesn't have hepatitis C [after the patients' medical histories were recorded, the patients were given hepatic screening as published elsewhere. 2
- •Presence of candidiasis before treatment.
- •Patients with pre-existing diabetes or an initial random glucose level exceeding 200 mg/dL before initiating steroid therapy were excluded.
- •Hypertensive patients
- •Contraindications for corticosteroid use (immunodeficiency or severe heamatological alterations).
研究组 & 干预措施
Omega-3 capsules 1000 mg
This group included 15 patients who received Omega-3 soft gelatin capsules 1000 mg (Super Omega; Technopharma, Cairo, Egypt). The patients received instruction to take one capsule three times daily for 3 months.
干预措施: Omega-3 soft capsules 1000 mg (Drug)
prednisone 50 mg tablet
This group included 15 patients who received prednisone (Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy) at 40mg /day (8 tablets/day in divided dose , 4 tablet at morning and 4 at evening) for 6 weeks then 20mg/day for 2 week then to 10 mg/day for 2 week, and finally to 5 mg /day for the last 2 weeks.
干预措施: Prednisone tablet 5mg (Drug)
结局指标
主要结局
Improve quality of the life (Oral Health Impact Profile)
时间窗: 6 months
Improve quality of the life was recorded at baseline, 3 and 6 months after treatment.
次要结局
- Size and types (atrophic/erosive) of the lesions(6 months)
- Recurrence of disease(3 months)
- Pain score (Visual analogue scale (VAS)),(6 months)
研究者
Enas Elgendy
Lecuture, October 6 University
October 6 University