The effect of Pilocarpine and omega-3 emulsion combined mouthwash on oral symptoms of Sjogren's syndrome
Phase 3
Recruiting
- Conditions
- Sjögren.Sicca syndrome [Sjogren]M35.0
- Registration Number
- IRCT20230419057964N1
- Lead Sponsor
- Shahre-kord University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
Being at the age of 18-75 years old
Documented diagnosis of primary or secondary Sjogren's syndrome with symptoms of dry mouth based on ACR criteria
Exclusion Criteria
Patients who are allergic to pilocarpine.
Suffering from heart, lung, kidney or digestive system diseases, diabetes and oral ulcers
Pregnancy
lactation
Being allergic to Pilocarpine
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The amount of saliva secretion. Timepoint: Before and 15 days after the intervention. Method of measurement: Saliva weight and dry mouth eleven-item questionnaire (XI).
- Secondary Outcome Measures
Name Time Method Dry mouth score in related questionnaire. Timepoint: Effectiveness of combined pilocarpine mouthwash and omega-3 emulsion before and 15 days after the intervention. Method of measurement: Questionnaire of the list of eleven items of dry mouth (XI).