]>
IRCT20230419057964N1 IRCT 2023-05-13 Shahre-kord University of Medical Sciences 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 2023-05-05 anticipated 44 Complete https://irct.ir/trial/69733 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Sjögren. 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 be given to the patients in the form of mouthwash. The medicine is prepared in the laboratory of compound medicines in the pharmaceutical care department of Hajar Hospital, and the products are prepared in 120 cc brown bottles and labeled with random codes so that the contents of the bottles are not known. To prepare local mucosal emulsion (mouthwash) "omega three and pilocarpine", from oil in water omega three emulsion 6.7% containing a mixture of Docosahexanoic Acid (DHA) Eicosapentaenoic Acid (EPA) produced in Amin Pharmaceutical Company, Iran and pilocarpine 2 solution % produced in Sina Daru Pharmaceutical Company is used. Before each dose, the patient shakes the medicine bottle well for 30 seconds, then gargles the volume of 5 ml using a measuring cup for one minute, and then spits it. Mouthwash is delivered to patients in a brown glass bottle with a volume of 225 cc for 15 days consumption in the first visit. The amount of saliva secretion is also evaluated by measuring the weight of a weighed cigarette filter placed in the patient's mouth for 5 minutes in both visits (the first day and the 15th day after taking the medicine) by the project manager. Intervention 2: Control group: standard treatment plus placebo. Half-saline (45% sodium chloride) will be used for the placebo solution. The placebo product is prepared in a 120 cc brown glass with exactly the same shape and packaging as the mouthwash and is labeled with random codes so that the contents of the glass are not clear. Before each dose, the patient shakes the medicine bottle well for 30 seconds, then gargles the volume of 5 ml using a measuring cup for one minute, and then spits it. Placebo is delivered to patients in a brown glass bottle with a volume of 225 cc for 15 days at the first visit. The amount of saliva secretion is also evaluated by measuring the weight of a weighed cigarette filter placed in the patient's mouth for 5 minutes in both visits (the first day and the 15th day after taking the medicine) by the project manager. Yes - There is a plan to make this available What will be shared: 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. When: The access period will start 6 months after the results are published. To whom: Our data will only be available to researchers working in academic and scientific institutions Conditions: 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. Where to obtain: 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 How to obtain: 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. Comments:
public Sadaf Baghernejad Monavar Gilani
Kashani street
Sharekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 baghernejad.sadaf@gmail.com Shahre-kord University of Medical Sciences scientific Mohammad Mousavi
Kashani street
Shahrekord Iran (Islamic Republic of) 8816754633 0383222116 moosavi@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) 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 18 years 75 years Both 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 M35.0 Sicca syndrome [Sjogren] Treatment - Drugs Treatment - Drugs 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 be given to the patients in the form of mouthwash. The medicine is prepared in the laboratory of compound medicines in the pharmaceutical care department of Hajar Hospital, and the products are prepared in 120 cc brown bottles and labeled with random codes so that the contents of the bottles are not known. To prepare local mucosal emulsion (mouthwash) "omega three and pilocarpine", from oil in water omega three emulsion 6.7% containing a mixture of Docosahexanoic Acid (DHA) Eicosapentaenoic Acid (EPA) produced in Amin Pharmaceutical Company, Iran and pilocarpine 2 solution % produced in Sina Daru Pharmaceutical Company is used. Before each dose, the patient shakes the medicine bottle well for 30 seconds, then gargles the volume of 5 ml using a measuring cup for one minute, and then spits it. Mouthwash is delivered to patients in a brown glass bottle with a volume of 225 cc for 15 days consumption in the first visit. The amount of saliva secretion is also evaluated by measuring the weight of a weighed cigarette filter placed in the patient's mouth for 5 minutes in both visits (the first day and the 15th day after taking the medicine) by the project manager. Control group: standard treatment plus placebo. Half-saline (45% sodium chloride) will be used for the placebo solution. The placebo product is prepared in a 120 cc brown glass with exactly the same shape and packaging as the mouthwash and is labeled with random codes so that the contents of the glass are not clear. Before each dose, the patient shakes the medicine bottle well for 30 seconds, then gargles the volume of 5 ml using a measuring cup for one minute, and then spits it. Placebo is delivered to patients in a brown glass bottle with a volume of 225 cc for 15 days at the first visit. The amount of saliva secretion is also evaluated by measuring the weight of a weighed cigarette filter placed in the patient's mouth for 5 minutes in both visits (the first day and the 15th day after taking the medicine) by the project manager. 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). 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). Shahre-kord University of Medical Sciences Approved 2023-02-08 Ethics committee of Sharekord University of Medical Sciences Kashani street Sharekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)