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IRCT20250311065040N1 IRCT 2025-04-22 Birjand University of Medical Sciences Evaluation of the effect of an artificial saliva produced from aqueous extract of Okra ( Abelmoschus Esculentus) on the xerostomia symptoms in diabetic patients Evaluation of the effect of an artificial saliva produced from aqueous extract of Okra ( Abelmoschus Esculentus) on the xerostomia symptoms in diabetic patients 2025-05-05 anticipated 80 Complete https://irct.ir/trial/82437 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups 1 (intervention) and 2 (control) using a block randomization method, for this purpose, blocks of four are formed including A, B. (For example: AABB, BABA, ABAB) Then, until the sample is completed, the blocks are selected by simple random selection. Also, A will be the intervention group (artificial saliva containing aqueous extract of okra) and B will be the control group (artificial saliva containing carboxymethyl cellulose), Blinding description: Study participants and the principal investigator (student performing the intervention and collecting the data) will be blinded by packaging the artificial saliva in the same way and not being aware of the assignment of individuals to the study groups. 3 Xerostomia. Intervention 1: Intervention group: People in this group, including 40 patients, will rinse their mouths with 2 ml of aqueous extract of okra fruit (30 g sorbitol, 11.7 g aqueous extract of okra, 804 mg dipotassium mono hydrogen phosphate, 625 mg potassium chloride, 366 mg potassium dihydrogen phosphate, 166 mg calcium chloride, 59 mg magnesium chloride, and sodium benzoate at a rate of 0.05% of the total solution as a preservative in 1000 g distilled water) 3 times a day for 2 weeks. Intervention 2: Control group: People in this group, including 40 patients, will rinse their mouths with 2 ml of carboxymethylcellulose solution with the formula (30 g sorbitol, 11.7 g carboxymethylcellulose, 804 mg dipotassium mono hydrogen phosphate, 625 mg potassium chloride, 366 mg potassium dihydrogen phosphate, 166 mg calcium chloride, 59 mg magnesium chloride and sodium benzoate at a rate of 0.05% of the total solution as a preservative in 1000 g distilled water) 3 times a day for 2 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Hossein Shirmehenji
Birjand Dental School, Corner of Pasdaran 3, Pasdaran Blvd.
Birjand Iran (Islamic Republic of) 1713643135 +98 56 3238 1700 h.shirmehenji@bums.ac.ir Birjand University of Medical Sciences scientific Dr. Parvin Parvaie
Birjand Dental School, Corner of Pasdaran 3, Pasdaran Blvd.
Birjand Iran (Islamic Republic of) 1713643135 +98 56 3238 1700 parvin.parvaie@yahoo.com Birjand University of Medical Sciences Iran (Islamic Republic of) Be between the ages of 18 and 65 years old Patients must have dry mouth, based on the Fox questionnaire with at least a positive response to 4 of the 9 questions on the questionnaire Diabetes based on diabetes diagnosis criteria 18 years 65 years Both Pregnancy Taking medications that reduce salivation Use of other artificial saliva products History of autoimmune diseases History of pneumonia Presence of oral or perioral lesions K11.7 Disturbances of salivary secretion Treatment - Drugs Treatment - Drugs Intervention group: People in this group, including 40 patients, will rinse their mouths with 2 ml of aqueous extract of okra fruit (30 g sorbitol, 11.7 g aqueous extract of okra, 804 mg dipotassium mono hydrogen phosphate, 625 mg potassium chloride, 366 mg potassium dihydrogen phosphate, 166 mg calcium chloride, 59 mg magnesium chloride, and sodium benzoate at a rate of 0.05% of the total solution as a preservative in 1000 g distilled water) 3 times a day for 2 weeks. Control group: People in this group, including 40 patients, will rinse their mouths with 2 ml of carboxymethylcellulose solution with the formula (30 g sorbitol, 11.7 g carboxymethylcellulose, 804 mg dipotassium mono hydrogen phosphate, 625 mg potassium chloride, 366 mg potassium dihydrogen phosphate, 166 mg calcium chloride, 59 mg magnesium chloride and sodium benzoate at a rate of 0.05% of the total solution as a preservative in 1000 g distilled water) 3 times a day for 2 weeks. Score obtained on the Fox questionnaire. Timepoint: Days 0 and 14 of the study. Method of measurement: Fox Dry Mouth Questionnaire. Birjand University of Medical Sciences Approved 2025-03-15 Ethics Committee of Birjand University of Medical Sciences Ghafari Birjand South Khorasan Iran (Islamic Republic of)