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Trial record 40 of 369 for:    sjogrens

Fish Oil (Omega 3 ) in Sjogren's Syndrome

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ClinicalTrials.gov Identifier: NCT05005806
Recruitment Status : Recruiting
First Posted : August 16, 2021
Last Update Posted : April 26, 2022
Information provided by (Responsible Party):
Aryan Mohamadfatih Jalal, Hawler Medical University

Brief Summary:
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 .

Condition or disease Intervention/treatment Phase
Sjogren's Syndrome Drug: Omega 3 fatty acid Drug: Placebo Phase 2 Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomised Double-blind Placebo-controlled Clinical Trial of Fish Oil (Omega 3 ) in Sjögren's Syndrome Patients
Actual Study Start Date : September 2, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 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.
Drug: Omega 3 fatty acid
omega 3 fatty acid soft gel

Placebo Comparator: placebo
placebo group ,placebo soft gel designed same as omega 3 contain Vitamin A 1000 mg twice daily for two months
Drug: Placebo
placebo soft gel

Primary Outcome Measures :
  1. Dry eye symptoms [ Time Frame: 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

  2. Dry mouth symptoms [ Time Frame: 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

Secondary Outcome Measures :
  1. schirmers tear test [ Time Frame: up to two months ]
    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.

  2. sialometry test [ Time Frame: up to two months ]
    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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05005806

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Contact: Aryan MF Jalal, M.B.CH.B 009647504880817 aryan.jalal87@yahoo.com
Contact: Ibtihal HH Faraj, M.B.CH.B 009647507584463 Ibtihal.hikmet@yahoo.com

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Reumatology out patient clinic, Recruiting
Erbil, Iraq, 44001
Sponsors and Collaborators
Hawler Medical University
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Study Director: Ziad SH AL Rawi, F R C P London Professor of Rheumatolgy,Baghdad University
Principal Investigator: Aryan MF Jalal, M.B.CH.B Rheumatology,Hawler medical uiversity,Kurdistan Board for medical specialities
Principal Investigator: Ibtihal HH Faraj, M-B.CH.B Rheumatology,Hawler medical university
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Responsible Party: Aryan Mohamadfatih Jalal, principal investigator, Hawler Medical University
ClinicalTrials.gov Identifier: NCT05005806    
Other Study ID Numbers: Fish oil in Sjogren Syndrome
First Posted: August 16, 2021    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aryan Mohamadfatih Jalal, Hawler Medical University:
Sjogren's syndrome
Omega 3 fatty acid
dry eye
dry mouth
Additional relevant MeSH terms:
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Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases