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IRCT20221229056981N1 IRCT 2023-04-15 Alborz University Of Medical Science Evaluation of the effect a herbal lozenge tablet containing ginger, green tea, hollyhock, and mallow and on saliva secretion in healthy volunteers. Evaluation of the effect a herbal lozenge tablet containing ginger, green tea, hollyhock, and mallow and on saliva secretion by measuring the difference in the weight of secreted saliva before and after taking the pill; in healthy volunteers. 2023-04-24 anticipated 25 Complete https://irct.ir/trial/67768 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Xerostomia. First intervention group: The lozenge used contains 500 mg of xylitol, 200 mg of green tea extract, 200 mg of ginger extract, 100 mg of marshmallow extract, and 100 mg of cheese extract. This lozenge was prepared in the laboratory of Alborz University of Medical Sciences. Two pre-weighed cotton rolls are placed on each side of the roof of the person's mouth. Then the cotton rolls are taken out and weighed again. In the second step, we perform all these steps after taking the lozenge and compare the results. The second intervention group: in this evaluation, after taking the lozenge, the volunteer will evaluate the sensory characteristics using the 5-point hedonic method by completing the evaluation questionnaire in the form of scoring.. Yes - There is a plan to make this available What will be shared: All of the collected data and information related to the main outcome or similar can be shared, for example, data related to the effect of the lozenge on the amount of saliva secretion and data related to the organoleptic profile of the lozenge. These data will be published in the form of article. When: The access is available since1402. After the end of the study and publication of data. To whom: All academic and industry researchers can receive the data without the names of the participants and respecting ethical principles. Conditions: Receiving the data depends on observing ethics in research and maintaining confidentiality, as well as observing the rights of the author regarding the ownership of the data. Where to obtain: By corresponding author's email. And also referring to the article or thesis. The thesis is available in the library of Alborz Faculty of Pharmacy . How to obtain: By sending email and also receive the article or read the thesis in Alborz Pharmacy School. Comments:
public Mohammad Mahdi Ahmadian-Attari
School of Pharmacy, Next to Imam Ali Hospital, Valiasr Street, Shora Blvd.
Karaj Iran (Islamic Republic of) 3154686689 +98 26 3256 7175 ahmadian.attari@gmail.com Alborz University of Medical Sciences scientific Mohammad Mahdi Ahmadian-Attari
School of Pharmacy, Next to Imam Ali Hospital, Valiasr Street, Shora Blvd.
Karaj Iran (Islamic Republic of) 3154686689 +98 26 3256 7175 ahmadian.attari@gmail.com Alborz University of Medical Science Iran (Islamic Republic of) 1. Participants should be 18 years old or older. And people over 60 years old or older should not participate in the study. 2. Candidates should not be patient, especially diseases which are regarded to salivary glands and oral mucosa. 3. Participants should not have dry mouth or dry eyes. 4. Participants must be able to read, complete and sign the consent form. They should also be able to understand and answer the questionnaire. 18 years 60 years Both 1. Intolerance to taking pills during the test and unwillingness to continue working. 2. People who answer "yes" to the questions about dryness. These people are considered "positive" for dry mouth and cannot participate in the study. 3. Lactating women and pregnant women. 4. Participants who complain of dry mouth or dry eyes. 5. Patients with oral lesions or other contact sensitivities. 6. Patients suffering from autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, systemic lupus erythematosus or progressive systemic sclerosis, because people with these autoimmune inflammatory diseases show persistent dry mouth. 7. People with acute or chronic use of drugs that cause dry mouth. Which includes drugs such as antihistamines, antipsychotics, antidepressants and etc. 8. Patients undergoing radiotherapy (mainly for the treatment of head and neck cancer). 9. People with chronic disease, if it is not well controlled. 10. People with HIV, hepatitis B or hepatitis C infection. K11.7 Disturbances of salivary secretion Treatment - Drugs First intervention group: The lozenge used contains 500 mg of xylitol, 200 mg of green tea extract, 200 mg of ginger extract, 100 mg of marshmallow extract, and 100 mg of cheese extract. This lozenge was prepared in the laboratory of Alborz University of Medical Sciences. Two pre-weighed cotton rolls are placed on each side of the roof of the person's mouth. Then the cotton rolls are taken out and weighed again. In the second step, we perform all these steps after taking the lozenge and compare the results. The second intervention group: in this evaluation, after taking the lozenge, the volunteer will evaluate the sensory characteristics using the 5-point hedonic method by completing the evaluation questionnaire in the form of scoring. The amount of saliva secretion. Timepoint: Before and after taking the lozenge. Method of measurement: By cotton weighing. In this way, before taking the lozenge, cotton it is placed in the volunteer's mouth and then it is weighed. The same process is repeated after taking the lozenge. Then, the difference in the weight of the cottons, which shows the increase in saliva secretion, is calculated. Organoleptic characteristics. Timepoint: Immediately after taking the pill. Method of measurement: Statistical analysis is done based on scoring the questionnaire regarding organoleptic characteristics. The questionnaire is evaluated in the form of scoring. Scores are analyzed statistically by Anova method. Alborz University Of Medical Science Approved 2022-11-12 Ethics committee of Alborz University of Medical Sciences Deputy of research and technology, Saffarian Alley, Golshahr Ave. Karaj Alborz Iran (Islamic Republic of)