Randomised Double-blind Placebo-controlled Clinical Trial of Fish Oil (Omega 3 ) in Sjögren's Syndrome Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Dry mouth symptoms
研究概览
简要总结
Sjögren's syndrome (pSS) is an autoimmune disorder affecting mainly the exocrine glands.this lead to dryness of the main mucosal surface ,such as the mouth ,eye,skin nose,pharynx,larynx and vagina . The history of the disease is characterized by a slowly progression of sicca symptoms and fatigue; however, a subset of patients would experience extra glandular activity. Lipid mediators derived from polyunsaturated fatty acids, related to inflammation and immune response regulation. In this sense, the polyunsaturated fatty acids omega-3 (ω-3 FA) have been associated with several illnesses such as cancer, cardiovascular disease and autoimmune diseases and their balance at the cellular membranes can result in an anti-inflammatory .
详细描述
this is a randomized double -blind placebo -controlled clinical trial .the participants will be randomize into two groups .Group 1 receive dietary omega-3 supplementation (omega-3 group) whereas Group 2(placebo group) receive a placebo . The two types are similar to each other in the form of soft gel ,both are given two times daily for two months with follow-up of patients whom they full fill the inclusion criteria.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥ 18 and ≤ 70 years old .
- •Able to provide inform consent
- •Patients diagnosed as syndrome according to 2016 ACR(American college of Rheumatology)/ EULAR(European league Against Rheumatism classification criteria for Sjögren's syndrome
排除标准
- •any preexisting ocular disease or on eye drops lubricants.
- •patients on (Beta blockers, Diuretics , anticholinergic, α 1antagonist and α 2 agonist ,anticoagulant, antidepressant, antihistamine ,pilocarpine, cevimeline ) .
- •past history of diabetes, psychiatric disorder.
- •pregnancy, lactating mother
- •malignancy
研究组 & 干预措施
Omega 3 soft gel
participants in this group (1)omega 3 fatty acid soft gel 1000 mg will be given to participants twice daily for two months.
干预措施: Omega 3 fatty acid (Drug)
placebo
placebo group ,placebo soft gel designed same as omega 3 contain Vitamin A 1000 mg twice daily for two months
干预措施: Placebo (Drug)
结局指标
主要结局
Dry mouth symptoms
时间窗: up to two months
measure dry mouth by inventory xerostomia score is included 11 questionnaire which score calculated by visual analogue scale from 1 to 5 ( never to very often ) have symptoms
Dry eye symptoms
时间窗: up to two months
subjective symptoms of dry eye which involve 6 symptoms( burning sensation, itching, foreign body sensation , Dryness, mucous discharge, photophobia) when absent(0) , sometime present (1) , frequently present (2), always present (3) ( score 0-6 mild, 6-12 moderate, 12-18 sever by visual analogue scale
次要结局
- sialometry test(up to two months)
- schirmers tear test(up to two months)
研究者
Aryan Mohamadfatih Jalal
principal investigator
Hawler Medical University