Fish Oil (Omega 3 ) in Sjogren's Syndrome

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

Official Title
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Randomised Double-blind Placebo-controlled Clinical Trial of Fish Oil (Omega 3 ) in Sjögren's Syndrome Patients

Conditions
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Sjogren's Syndrome

Intervention / Treatment
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* Drug: Omega 3 fatty acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 100 participants will asses for eligibility and underwent randomized double blind placebo controlled clinical trial .in whom they meet inclusion criteria with informed consent from participants and will be held at out patient clinic of Rheumatology department at Erbil- Iraq.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega 3 soft gel<br>participants in this group (1)omega 3 fatty acid soft gel 1000 mg will be given to participants twice daily for two months. | Drug: Omega 3 fatty acid<br>* omega 3 fatty acid soft gel<br>|
| Placebo Comparator: placebo<br>placebo group ,placebo soft gel designed same as omega 3 contain Vitamin A 1000 mg twice daily for two months | Drug: Placebo<br>* placebo soft gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dry eye symptoms | 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 | up to two months | 
| Dry mouth symptoms | 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 | up to two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| schirmers tear test | patient will sitt in examining chair ,the test strip is bend with round wick and at indentation ( approximately 90 degree ) then patient instruct to look up and draw eye gently downward ,then round bend end of sterile strip hook over eyelid border at junction of middle and outer one third of the lower eyelid margin. | up to two months | 
| sialometry test | measuring of salivary flow ,unstimulated whole saliva is collect when mouth rinse with distill water then the patient tow his head and try not to move during the test, a plastic disposable pipette drew the accumulated saliva in the floor of the mouth,for a period of five minute,the volume will record ,flow express as ml/min. | up to two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry mouth, Sjogren's syndrome, Omega 3 fatty acid, dry eye