]>
IRCT20221028056330N1 IRCT 2023-02-02 Tehran University of Medical Sciences Effect of pomegranate flower syrup in preventing mucositis Investigating the effect of pomegranate flower syrup in preventing severe mucositis caused by radiotherapy after head and neck cancer surgery 2023-02-20 anticipated 120 Complete https://irct.ir/trial/68105 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using coded boxes with a random sequence In this method, a number of boxes or cans that are numbered based on a random sequence are used. In these boxes, drugs or sheets with random allocation are used. If researchers use this method, they should make sure that the boxes are sealed enough, their appearance is similar, and their weight is the same. In this study, the drug container and the placebo have a clear similarity, and neither the researcher nor the patient knows about it, Blinding description: The patient does not know about the type of syrup received The researcher also has no information about the type of syrup received by the patient The pharmacist only knows about the syrup received by the patients and delivers the medicine to the patients. 2 Mucositis caused by radiotherapy. Intervention 1: Intervention group: Including 60 patients who receive pomegranate flower mouthwash in the amount of 10 cc 3 times a day. To prepare the product, firstly, pomegranate flower is procured from the medicinal plant market of Iran and a herbarium code is assigned to it by a botanist. To prepare 240 cc of pomegranate flower syrup, dissolve 8 grams of hydroalcoholic extract (70 degrees) prepared by maceration method and dried by rotary machine and vacuum in some distilled water, then add xylitol (sweetener) and methyl paraben (preservative). We add the volume of the solution with distilled water. We increase the pH of the placebo syrup to 240 cc. Finally, if needed, the viscosity-increasing and regulating agent isylitol is made as a sweetener and methyl paraben as a preservative, and the food coloring is used to match its color with pomegranate flower syrup. Standardization of syrup is done by determining the amount of total phenolic compounds through Folin Cicalto test, and gallic acid is used as a standard. The microbial control of the syrup is also done to ensure that the count of microorganisms is within the permissible limits of the pharmacopoeia. Patients undergo weekly visits from the first day of treatment to the end of radiotherapy for a total of 6-7 weeks. Intervention 2: Control group: 60 patients who receive placebo in the amount of 10 cc 3 times a day. Yes - There is a plan to make this available What will be shared: The published information is related to the effect of pomegranate flower syrup in preventing mucositis and its effect on patient nutrition and weight gain When: The access period is expected to start from 1404 To whom: Researchers working in academic institutions Conditions: After completing the research, the data can be used for non-employees in the institutions as well. Where to obtain: Email the following address to receive information and documents dr.fatemeh.samadi@gmail.com How to obtain: After the completion of the research and data analysis, and considering that the patient is admitted until the end of 1403, the second six months of 1404, information and files can be accessed. Comments:
public fatemeh samadi
Cancer Institute, Imam Khomeini Hospital, Gharib Street, Keshavarz Blvd
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6119 2585 dr.fatemeh.samadi@gmail.com Tehran University of Medical Sciences scientific Fatemeh Samadi
Cancer Institute, Imam Khomeini Hospital, Gharib AVe
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6119 2585 dr.fatemeh.samadi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) The study of patients with head and neck cancers who are candidates for at least 50 Gy radiotherapy to the oral cavity with or without concurrent chemotherapy after surgery will be included in the study. 18 years no limit Both Patients who had a history of head and neck radiotherapy, opium addiction or methadone use, active mucosal disease in the radiotherapy area and people under 18 years of age are excluded from the study. Treatment - Drugs Placebo Intervention group: Including 60 patients who receive pomegranate flower mouthwash in the amount of 10 cc 3 times a day. To prepare the product, firstly, pomegranate flower is procured from the medicinal plant market of Iran and a herbarium code is assigned to it by a botanist. To prepare 240 cc of pomegranate flower syrup, dissolve 8 grams of hydroalcoholic extract (70 degrees) prepared by maceration method and dried by rotary machine and vacuum in some distilled water, then add xylitol (sweetener) and methyl paraben (preservative). We add the volume of the solution with distilled water. We increase the pH of the placebo syrup to 240 cc. Finally, if needed, the viscosity-increasing and regulating agent isylitol is made as a sweetener and methyl paraben as a preservative, and the food coloring is used to match its color with pomegranate flower syrup. Standardization of syrup is done by determining the amount of total phenolic compounds through Folin Cicalto test, and gallic acid is used as a standard. The microbial control of the syrup is also done to ensure that the count of microorganisms is within the permissible limits of the pharmacopoeia. Patients undergo weekly visits from the first day of treatment to the end of radiotherapy for a total of 6-7 weeks. Control group: 60 patients who receive placebo in the amount of 10 cc 3 times a day. Severity of mucositis according to who definition. Timepoint: Checking the severity of mucositis every week during radiotherapy. Method of measurement: Based on the definition of the severity of mucositis of the World Health Organization. Severity of mucositis based on who definition. Zero grade: The patient has no symptoms. Grade 1: Erythema and mouth burning (brief mucosal inflammation) Grade 2: Erythema and oral ulcers that still have the ability to eat solid foods. (Mild pain that requires painkillers.) Grade 3: Ulcers with extensive erythema who cannot swallow solid food. (Severe pain that requires strong pain relief) Grade 4: Mucositis has become very widespread and has made feeding completely impossible for the person, and at the same time that there is a need for hospitalization for him. Tehran University of Medical Sciences Approved 2022-08-30 Ethics committee of tehran University of Medical Sciences Central Building of Tehran University of Medical Sciences, Intersection of Quds St, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)