The effect of Pilocarpine and omega-3 emulsion combined mouthwash on oral symptoms of Sjogren's syndrome

Evaluation the effectiveness of a combined mouthwash of pilocarpine and omega-3 emulsion with placebo on oral symptoms of patients with Sjögren syndrome

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230419057964N1

Enrollment

Registered

2023-05-13

Start date

2023-05-05

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjögren. Sicca syndrome [Sjogren]

Interventions

Intervention 1: Intervention group: Standard treatment plus pilocarpine drug with a concentration of 1% (Sina Daru Company) along with Omega 3 emulsion with a concentration of 1% (Amin Company) will b

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSadaf Baghernejad Monavar Gilani

Shahre-kord University of Medical Sciences

baghernejad.sadaf@gmail.com+98 38 3222 0016

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026