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

Comparison of the effectiveness of chewing gum with and without ginger on dry mouth

Clinical trial with control group, with parallel groups , double-blind , randomized , phase 3 on 28 patients. Balanced block randomization method was used for randomization.

This study is performed on patients undergoing hemodialysis in the dialysis ward of Imam Khomeini Hospital in Tehran. Patients enter the study after obtaining informed consent and confirmation of dry mouth. Stimulated and non-stimulated saliva of patients is collected before and after the intervention and also questionnaires are provided to assess the quality of life and severity of dry mouth. Patients and the reader will not know the content of chewing gum.

Patients will be selected according to the following inclusion criteria: People of both sexes over 18 years old , Confirmation of dry mouth Exclusion criteria include: 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 , Conditions affecting salivary flow rate

Intervention group: Recipient of 60 gums containing 0.15 g of ginger (formulated by a pharmacologist) for 14 days 4 times a day Control group: Recipient of 60 chewing gums with the same ingredients in the intervention group only without ginger for 14 days 4 times a day

Stimulated saliva , Unstimulated saliva , Oral health related quality of life , Severity of dry mouth

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.

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.