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 .
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
omega 3 fatty acid soft gel
placebo soft gel
Reumatology out patient clinic,
Erbil, Iraq
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
Time frame: 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
Time frame: up to two months
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.
Time frame: 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.
Time frame: up to two months
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