The evaluation of effect of purslane and marshmallow combined extract in the Improvement of symptoms of dry mouth

To investigate the effect of syrup containing marshmallow and purslane extracts on improving symptoms of dry mouth, including oral moisture, mucus stickiness, saliva secretion, and swallowing and speech disorders.

A triple-blind, parallel-group, randomized, phase 3 clinical trial on 60 patients. Randomization will be performed using a simple method and sequential allocation.

Zahedan Dental School. Participants will be selected from patients with dry mouth. The syrups are coded in identical bottles and are similar in appearance, taste, smell, and consistency. Symptoms of dry mouth will be assessed and recorded before the start of the intervention and in the second and fourth weeks. Data will be collected using a standardized questionnaire and clinical examinations.

Inclusion criteria: Diagnosis of dry mouth based on a standard questionnaire (positive response to at least three questions). Objective dry mouth index above 30. No tobacco, alcohol, or drug use. Not pregnant or breastfeeding. No history of chemotherapy or radiotherapy in the past six months. No use of corticosteroids or drugs that affect saliva secretion. Inclusion criteria: Unwillingness to participate in the study or failure to complete the informed consent form.

Intervention group: They receive syrup containing marshmallow and purslane extract. The syrup is prescribed as directed for 4 weeks, three times a day, one spoonful at a time. Control group: They receive syrup with the same appearance, consistency, taste, and smell as the intervention syrup, but without the active ingredient, in the same manner as the intervention group.

Moisture of the oral mucosa; amount of saliva secretion; reduction of adhesion of the mucosa to the teeth; improvement of swallowing disorders; improvement of speech disorders.

Randomization method: Randomization was performed in a simple way. Individuals were randomly assigned to the intervention and control groups based on the order of presentation. Alternate Allocation was used, with one person assigned to the intervention group and the next to the control group. Randomization unit: Randomization was performed on an individual basis, meaning that each participant was placed individually in one of the two groups. Randomization strata: Stratified randomization was not performed in this study. Randomization tool: Allocation was performed based on sequential presentation and was managed manually. No random number table or statistical software was used for this study. How to construct the random sequence: The random sequence was set up through simple sequential division. The first, third, fifth, etc., patients were assigned to the intervention group, and the second, fourth, sixth, etc., patients were assigned to the control group. Allocation Concealment: To maintain neutrality and conceal allocation, the drug and placebo syrups were prepared in identical bottles with identical coding. The researchers, patients, and statistical analysts were unaware of the contents of the bottles, and the procedure was triple-blind.

The blinding of each group is as follows: 1. Participants: Participants are unaware of whether they are in the intervention group (purslane and marshmallow syrup) or the control group (placebo). The intervention and placebo syrups are designed to be completely similar in appearance (color, consistency, taste, and packaging) so that there is no discernible difference. 2. Clinical caregivers (doctors and nurses): The people responsible for prescribing the syrup and caring for the patients are unaware of the type of syrup (intervention or placebo). The syrups are provided in a coded form and the caregivers only provide the participants with instructions for use. 3. Researchers: The principal investigator and the members of the research team who supervise the implementation of the study and collect the data are unaware of the allocation of patients to the intervention and control groups. The coding of the syrups is done by an independent person or team so that the researchers are not influenced by the process of conducting the study. 4. Outcome assessors: The individuals who assess and record treatment outcomes (such as oral moisture, mucosal adhesion, ease of swallowing, etc.) are unaware of the type of intervention or grouping of participants. The data are recorded in coded form to ensure confidentiality during analysis. 5. Data analysts: The data analysis team, which is responsible for processing the information and extracting the results, has access only to the coded data and is unaware of the group allocation. 6. Data safety and monitoring committee (if any): No such committee was formed in this study. Blinding implementation mechanisms: The syrups were prepared and coded by the Traditional Medicine Laboratory of Shahid Beheshti University of Medical Sciences. The code list is kept only by an independent person outside the research team to provide access to the information in case of emergency. All data and questionnaires are recorded in coded form to maintain blinding until the end of data analysis.

identified data for primary and secondary outcomes, may be shared upon reasonable request. Additional documents such as the study protocol, statistical analysis plan, and informed consent forms will also be made available for sharing.

The period of access to data and documentation will begin 6 months after the publication of the study results and will continue for 2 years.

The study data and documentation will be available to researchers working in academic and scientific institutions, independent researchers, and individuals working in industry working in fields related to the study subject, subject to a justified request and approval by the research team.

Type of use: Data and documentation may only be used for research and educational purposes, such as conducting new analyses or secondary studies. Any commercial use of the data is not permitted. Requirements for submitting an application: A written application must include a full explanation of the purpose of using the data. A research plan that indicates how the data will be used. A signed agreement by the applicant to maintain confidentiality of the data and cite the original study if the results are published. Analysis limitations: Data analysis must be within the scope of the research objectives stated in the application. Any use outside the scope of the application requires a new license. Monitoring mechanism: The research team will have the right to monitor how the data is used. If necessary, the data will be provided in an anonymized and confidential manner.

Name of the coordinator: Dr. Masoumeh Shirzaei

Submitting a written request: The applicant must submit their request in writing to the study coordinator, explaining the purpose of the research and the proposed design. The request must include the following information: Purpose of using the data. Proposed method for analyzing the data. Ensure compliance with the principles of confidentiality and research ethics. Reviewing the request: The research team will review the request and make a decision. This process may take up to 15 business days. Signing the agreement: If the request is approved, the applicant must sign an agreement that includes the terms of use of the data and the obligation to cite the original study in the research results. Preparing and sending the data: The data will be prepared in an anonymized form, along with relevant documentation, and sent to the applicant via email or a secure platform. This step may take up to 10 business days. Total time: The process from submitting the request to receiving the data usually takes about 3 to 4 business weeks. The applicant can contact the study coordinator via email or phone throughout the process to be informed of the status of their application.