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IRCT20240812062737N1 IRCT 2024-11-14 Hamedan University of Medical Sciences Investigating the effect of Ginger mouthwash on saliva secretion in hemodialysis patients Investigating the effect of Ginger mouthwash on saliva secretion in hemodialysis patients 2024-11-27 anticipated 90 Complete https://irct.ir/trial/78563 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose, we will use the quadruple block randomization method. For this purpose, we prepare four sheets of paper. We write the letter I meaning "Intervention" on two sheets and the letter C meaning "Control" on the other two sheets. We mix the sheets together and put them in the desk drawer. Upon the referral of each eligible patient, one of the sheets will be randomly drawn and based on this drawn sheet, whether it is I or C, they will be assigned to one of the two intervention groups (the recipient of ginger mouthwash) or control. It should be noted that the drawn cards will not be returned to the drawer until all four cards have been drawn. After randomly pulling out all four sheets, all the sheets are returned to the drawer and the above procedure will be continued for the next four patients until the desired sample size is reached. N/A Salivary secretion rate of hemodialysis patients. Intervention 1: Intervention group: The patient will take mouthwash three times a day for two weeks. Before starting to use the mouthwash, one week later and two weeks later, the saliva volume will be measured and the questionnaire will be filled by the patient, and based on the average result at the end of the first and second week, the effectiveness of the mouthwash will be checked. Intervention 2: Control group: The patient will take placebo three times a day for two weeks. Before starting to take the placebo, one week later and two weeks later, the saliva volume will be measured and the questionnaire will be filled by the patient, and based on the average result at the end of the first and second week, the effectiveness of the placebo will be checked. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: The data will be available only to researchers working in academic and scientific Conditions: People who intend to use the study data for review articles and meta-analysis Where to obtain: Atefe Kahrizi email How to obtain: After checking the requester's email by Atefe Kahrizi, if the conditions are met, the data will be sent to them 3 days later Comments:
public Atefe Kahrizi
Hamadan university of medical sciences, Fahmideh St
Hamedan Iran (Islamic Republic of) 651783867 +98 81 3252 0182 a.d.kahrizi96@gmail.com Hamedan University of Medical Sciences scientific Hamedan University of Medical Sciences
Hamadan university of medical sciences, Fahmideh St
Hamedan Iran (Islamic Republic of) 6517838678 0855+5541 a.d.kahrizi96@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) It is better for the patients to have no special mental or physical diseases or sensitivity and dry eyes. The patient should undergo dialysis three times a week and each time for at least 3.5 hours. no limit no limit Both Diabetic patients Pregnant women or people who complain of dry eye disease. Patients who have undergone radiation therapy (mainly for the treatment of head and neck cancer). People infected with HIV, Hepatitis B or Hepatitis C (based on the medical record available in the dialysis department) Smoking Allergy to Ginger Refusal to continue cooperation Treatment - Other Placebo Intervention group: The patient will take mouthwash three times a day for two weeks. Before starting to use the mouthwash, one week later and two weeks later, the saliva volume will be measured and the questionnaire will be filled by the patient, and based on the average result at the end of the first and second week, the effectiveness of the mouthwash will be checked. Control group: The patient will take placebo three times a day for two weeks. Before starting to take the placebo, one week later and two weeks later, the saliva volume will be measured and the questionnaire will be filled by the patient, and based on the average result at the end of the first and second week, the effectiveness of the placebo will be checked. Investigating the effect of ginger mouthwash on salivary glands. Timepoint: The beginning of the study, the end of the first week, the end of the second week. Method of measurement: Quantitative measurement and xerostomia questionnaires. The amount of saliva secretion. Timepoint: The beginning of the study, the end of the first week and the end of the second week. Method of measurement: Quantitative measurement using graduated Falcon tube and dry mouth questionnaire. Hamedan University of Medical Sciences Approved 2024-11-09 Ethics committee of Hamadan University of medical sciences Hamadan University of medical science, Shahid Fahmide Boulevards Hamedan Hamadan Iran (Islamic Republic of)