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

Determining the effectiveness of combined pilocarpine mouthwash and omega-3 emulsion in improving the oral symptoms of Sjogren's patients compared to placebo.

Clinical trial with control group and parallel design. In this clinical trial, 44 patients with Sjogren's syndrome with symptoms of dry mouth will be included in the study and will randomly be divided into two groups of 22 people. Forty four identical cards, 22 have the letter A and 22 have the letter B, are placed in an envelope in a jumbled manner, and for each patient, we take out one card randomly.

This study will be conducted in the Hajar educational-therapeutic center in Shahrekord on patients with Sjogren's syndrome (primary and secondary) with symptoms of dry mouth who have referred to the educational clinic of Hajar Hospital. This clinical trial study will be double-blind; Considering that the contents of the jars are not known, the researcher and the patient are blind to the intervention and the labeling is done with a random code (not with the contents).

Inclusion criteria: Age of 18-75 years old; Documented diagnosis of primary or secondary Sjogren's syndrome. Non-inclusion criteria: heart, lung, kidney or digestive system diseases, diabetes and oral ulcers; pregnancy; breastfeeding; being allergic to pilocarpine

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) in the form of mouthwash. Placebo group: standard treatment plus placebo

Saliva weight; Dry mouth questionnaire (XI) score

In this clinical trial, 44 patients with Sjogren's syndrome with symptoms of dry mouth were included in the study and were randomly divided into two groups of 22 people under the name of combined pilocarpine and omega-3 emulsion mouthwash group and placebo group.For this purpose, 44 identical cards, 22 of which have the letter A and 22 of which have the letter B, are placed in an envelope in a jumbled manner and for each patient, we take out one card at random. The letter written on the card will show the patient's treatment.

This clinical trial study will be double-blind; Considering that the contents of the jars are not clear, the researcher is blind to the intervention. Considering that the patient is not aware of the contents and the labeling is done with a random code (not with the contents), the patient is also blind to the intervention.

To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published.

The access period will start 6 months after the results are published.

Our data will only be available to researchers working in academic and scientific institutions

If possible, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data.

In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address baghernejad.sadaf@gmail.com or the contact number 00989122982219

To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most.