Clinical trial

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

Name
Fish oil in Sjogren Syndrome
Description
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 .
Trial arms
Trial start
2021-09-02
Estimated PCD
2023-02-01
Trial end
2023-02-07
Status
Completed
Phase
Early phase I
Treatment
Omega 3 fatty acid
omega 3 fatty acid soft gel
Arms:
Omega 3 soft gel
Placebo
placebo soft gel
Arms:
placebo
Size
100
Primary endpoint
Dry eye symptoms
up to two months
Dry mouth symptoms
up to two months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2024-02-28

1 organization

1 product

1 drug

1 indication

Product
Omega 3