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IRCT20191012045067N11 IRCT 2025-01-09 Zahedan University of Medical Sciences The evaluation of effect of purslane and marshmallow combined extract in the Improvement of symptoms of dry mouth PEMD The evaluation of effect of purslane and marshmallow combined extract in the Improvement of symptoms of dry mouth 2025-01-20 anticipated 60 Complete https://irct.ir/trial/81028 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Dry mouth (xerostomia). Intervention 1: Intervention group: Syrup containing marshmallow and purslane extract prepared in the laboratory of the Traditional Medicine Research Center of Shahid Beheshti University of Medical Sciences. This syrup contains concentrated aqueous extract of marshmallow and purslane plants (with a plant to water ratio of 1:20), sugar (25%), preservatives (methylparaben and propylparaben 0.2%), and carboxymethylcellulose thickener (0.25%). Standardization was performed based on total polyphenols. Dosage: Amount: One tablespoon. Frequency of use: Three times a day. Duration of use: 4 weeks. Method of use: The syrup was administered orally and participants reported regular consumption according to the instructions. Control group: Placebo with a formulation similar to the intervention syrup (in terms of appearance, taste, odor, and consistency) but without the active ingredient (herbal extract). Ingredients: Sugar (25%), preservatives (methylparaben and propylparaben 0.2%), thickener carboxymethylcellulose (0.25%), and water. Dosage: One tablespoon. Frequency of use: Three times a day. Duration of use: 4 weeks. Placebo and intervention syrup are coded in similar bottles and are presented in a triple-blind manner. Intervention 2: Control group: Control group: Participants in this group receive placebo. The placebo contains ingredients similar to the intervention syrup in terms of appearance, consistency, taste, and odor, but does not contain the active ingredient (marshmallow and purslane extract). Placebo ingredients: Sugar: 25%. Preservatives: Methylparaben and propylparaben (0.2%). Thickener: Carboxymethylcellulose (0.25%). Water. Dosage: Amount: One tablespoon. Frequency of use: Three times a day. Duration of use: 4 weeks. How to use: The placebo is administered orally and participants consume it regularly according to the instructions. Blinding characteristics: The placebo and intervention syrup are coded in similar bottles and do not differ in appearance or other characteristics. Participants, researchers, and outcome assessors are unaware of the type of intervention. 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 No more information available.
public Masoomeh Shirzaiy
Azadegan street-dental school
Zahedan Iran (Islamic Republic of) 9817699693 +98 54 3344 1824 shirzaiy@gmail.com Zahedan University of Medical Sciences scientific Masoomeh Shirzaiy
Azadegan street-dental school
Zahedan Iran (Islamic Republic of) 9817699693 +98 54 3344 1824 shirzaiy@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) To diagnose dry mouth (xerostomia), patients must exhibit symptoms of dry mouth (based on answering at least 3 positive questions from a standard dry mouth questionnaire). No alcohol, cigarettes, or other tobacco products Not pregnant - breastfeeding No history of chemotherapy or radiotherapy in the past six months Not taking corticosteroids no limit no limit Both Lack of cooperation from patients K11.7 Disturbances of salivary secretion Treatment - Drugs Placebo Intervention group: Syrup containing marshmallow and purslane extract prepared in the laboratory of the Traditional Medicine Research Center of Shahid Beheshti University of Medical Sciences. This syrup contains concentrated aqueous extract of marshmallow and purslane plants (with a plant to water ratio of 1:20), sugar (25%), preservatives (methylparaben and propylparaben 0.2%), and carboxymethylcellulose thickener (0.25%). Standardization was performed based on total polyphenols. Dosage: Amount: One tablespoon. Frequency of use: Three times a day. Duration of use: 4 weeks. Method of use: The syrup was administered orally and participants reported regular consumption according to the instructions. Control group: Placebo with a formulation similar to the intervention syrup (in terms of appearance, taste, odor, and consistency) but without the active ingredient (herbal extract). Ingredients: Sugar (25%), preservatives (methylparaben and propylparaben 0.2%), thickener carboxymethylcellulose (0.25%), and water. Dosage: One tablespoon. Frequency of use: Three times a day. Duration of use: 4 weeks. Placebo and intervention syrup are coded in similar bottles and are presented in a triple-blind manner. Control group: Control group: Participants in this group receive placebo. The placebo contains ingredients similar to the intervention syrup in terms of appearance, consistency, taste, and odor, but does not contain the active ingredient (marshmallow and purslane extract). Placebo ingredients: Sugar: 25%. Preservatives: Methylparaben and propylparaben (0.2%). Thickener: Carboxymethylcellulose (0.25%). Water. Dosage: Amount: One tablespoon. Frequency of use: Three times a day. Duration of use: 4 weeks. How to use: The placebo is administered orally and participants consume it regularly according to the instructions. Blinding characteristics: The placebo and intervention syrup are coded in similar bottles and do not differ in appearance or other characteristics. Participants, researchers, and outcome assessors are unaware of the type of intervention. Oral mucosal moisture: Checking the presence or absence of saliva in the floor of the mouth and the surface of the mucosa through clinical examination. Timepoint: Measurement time points - Persian: Measurement of outcome variables is carried out at three time points: before the start of the intervention (beginning of the study). Two weeks after the start of the intervention. Four weeks after the start of the intervention (end of the study). Method of measurement: Oral mucosal moisture: Through clinical examination, observing the presence or absence of saliva on the floor of the mouth and the surface of the mucosa. Salivary secretion rate: Measuring unstimulated saliva by spitting into a test tube (milliliters per minute). Timepoint: Measurement time points - Persian: Measurement of outcome variables is carried out at three time points: before the start of the intervention (beginning of the study). Two weeks after the start of the intervention. Four weeks after the start of the intervention (end of the study). Method of measurement: Salivary secretion rate: Collecting unstimulated saliva by spitting into a test tube for 5 minutes and measuring its volume (milliliters per minute). Mucous adhesion: Checking the adhesion of mucus to the teeth and absalon through clinical examination. Timepoint: Measurement of outcome variables is carried out at three time points: before the start of the intervention (beginning of the study). Two weeks after the start of the intervention. Four weeks after the start of the intervention (end of the study). Method of measurement: Mucus adhesion: Using the abseiling method (adhesion or non-adhesion of the abseiling to the oral mucosa) in clinical examination. Swallowing disorder: Checking the ability to swallow dry food (such as plain biscuits) without the need to drink water. Timepoint: Measurement time points - Persian: Measurement of outcome variables is carried out at three time points: before the start of the intervention (beginning of the study). Two weeks after the start of the intervention. Four weeks after the start of the intervention (end of the study). Method of measurement: Swallowing disorder: Examining the patient's ability to swallow dry food such as plain biscuits without drinking water at the same time. Speech disorder: Checking the need to drink water to speak and assessing the ease of speaking through a questionnaire and interview. Timepoint: Measurement time points - Persian: Measurement of outcome variables is carried out at three time points: before the start of the intervention (beginning of the study). Two weeks after the start of the intervention. Four weeks after the start of the intervention (end of the study). Method of measurement: Speech disorder: Assessing the ease of speech through a standard dry mouth. Zahedan University of Medical Sciences - Vice President of Research and Technology, Faculty of Dentistry Approved 2024-11-03 Zahedan University of Medical Sciences Azadegan street-dental school Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)