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

INTERVENTION: 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 CONDITION: Dry mouth (xerostomia). ; Disturbances of salivary secretion K11.7 INCLUSION CRITERIA: 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 si Xmonths Not taking corticosteroids PRIMARY OUTCOME: 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. 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). 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. 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.