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IRCT20201201049550N1 IRCT 2021-01-03 Tehran University of Medical Sciences Comparison of the effectiveness of chewing gum with and without Ginger officale on dry mouth condition in patients under hemodialysis Double blinded parallel randomized clinical trial to determine the effect of chewing gum containing Zingiber officale on dry mouth condition in patients under hemodialysis in comparison with chewing gum without Zingibr officale 2020-12-30 anticipated 28 Complete https://irct.ir/trial/52725 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization list will be prepared by a third person who is not involved in the study. The randomization method is the "balanced block randomization" method, in which the people who will participate in the study, in the order of entry into the study, will be divided into blocks whose size is determined by the third person. So, the people in the study remain unaware of the size of the blocks, and this number will remain hidden. And the allocation of each person in each block will be done equally between the two groups by generating random numbers in MS Excel software (e.g., if the block size is 4, in MS Excel software 2 codes A and 2 codes B will be written in 4 rows and a random number will be created in front of each of them and by sorting these 4 rows based on random numbers, the codes (A and B) will be randomly assigned to the members of a given block. This will be done for all other blocks as well. The assignment of codes A and B to the intervention and placebo will be done with a simple random method by a third person and will be reopened after analyzing the data and finalizing the results. The third person will write sequential numbers from one to “n” (sample size) based on the random allocation list on the uniform packages of chewing gum, and thus the participants in the study and the researchers will be unaware of the contents of packages and groupings (even A or B). The random allocation list will be opened after data collection to identify two study groups for statistical analysis, Blinding description: In this intervention, medicated chewing gum and placebo are available and the method of blinding is done in such a way that the gums containing ginger and placebo chewing gum are placed in the same package and are encrypted by a third party and then provided to the participants. Participants, the lead researcher (who is also responsible for patient care) and the data analyzer will not know the content of the gums. 3 Xerostomia. Intervention 1: Intervention group: In this study, 60 gums containing ginger formulated by a pharmacist, weighing 1.5 g containing 0.15 g of ginger, are given to the intervention group. The duration of the study will be 14 days. Chewing gum should be chewed at least 4 times a day for 10 minutes during the study. Intervention 2: Control group: In this study, 60 gingerless gums (with the same composition of the intervention group only without ginger) formulated by the pharmacist, weighing 1.5 g, are given to the control group. The duration of the study will be 14 days. Chewing gum should be chewed at least 4 times a day for 10 minutes during the study. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the lack of a definite decision
public Fatemeh Dadashi
No.16 ,North Kargar St.,Enghelab Sq
Tehran Iran (Islamic Republic of) 1439957181 +98 41 3776 4273 lida.dadshi1996@yahoo.com Tehran University of Medical Sciences scientific Sara Pourshahidi
ِDental School , North Kargar St , Tehran
Tehran Iran (Islamic Republic of) 1439955934 +98 21 8835 8534 s-pourshahidi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) People of both sexes over 18 years old Confirmation of dry mouth, regardless of the cause, by the standard dry mouth questionnaire, which includes questions related to the amount of saliva in the mouth, swallowing difficulty, a feeling of dryness while eating, the need to drink water while eating, will be examined. 18 years no limit Both Patients who are unable to chew gum due to oral conditions History of allergic reaction to chewing gum and its contents , including ginger Severe cognitive deterioration Effective conditions on salivary flow rate : salivary gland aplasia , severe dehydration , chemotherapy , radiation to the head and neck and medications includes : ( Tricyclics Anti Deppressants - Tranquiliser - Sedative - Anticoagulants - Antihistamines - Antihypertensive drugs - Antispasmodic and diuretics ) - Sjogren's syndrome - Diabetes Mellitus - Sarcoidosis - Human immuno deficiency virus - Hepatitis C - Graft versus Host Disease (GvHD) - Mental Disorders - Primary biliary Cirrhosis - Systemic lupus erythematosus - Rheumatoid arthritis K11.7 Disturbances of salivary secretion Treatment - Drugs Treatment - Drugs Intervention group: In this study, 60 gums containing ginger formulated by a pharmacist, weighing 1.5 g containing 0.15 g of ginger, are given to the intervention group. The duration of the study will be 14 days. Chewing gum should be chewed at least 4 times a day for 10 minutes during the study. Control group: In this study, 60 gingerless gums (with the same composition of the intervention group only without ginger) formulated by the pharmacist, weighing 1.5 g, are given to the control group. The duration of the study will be 14 days. Chewing gum should be chewed at least 4 times a day for 10 minutes during the study. Stimulated saliva level. Timepoint: Measurement of stimulated saliva and non-stimulating saliva before the intervention and 14 days after chewing gum. Method of measurement: Measurement of stimulated saliva in milliliters in a plastic vial. Unstimulated saliva. Timepoint: Measurement of non-stimulating saliva before the intervention and 14 days after begining the intervention. Method of measurement: Measurement of non-stimulating saliva in milliliters in a plastic vial. Oral health related quality of life. Timepoint: Before the intervention and 14 days after the intervention. Method of measurement: Oral Health Impact Profile-14 ( OHIP-Per14 ) questionnaire. Severity of dry mouth. Timepoint: Before the intervention and 14 days after the intervention. Method of measurement: Xerostomia Inventory (XI) questionnaire (11 questions). Tehran University of Medical Sciences Approved 2020-07-26 Ethics Committee of the School of Dentistry, Tehran University of Medical Sciences School of Dentistry.,Tehran University of Medical Sciences.,North Kargar End.,Enghelab Sq Tehran Tehran Iran (Islamic Republic of)