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IRCT20200128046288N2 IRCT 2020-05-16 Ahvaz University of Medical Sciences Evaluation the effect of extracts of Cydonia oblonga, Punica granatum and Phyllanthus emblica on the prevention of gastric disease in hospitalized burned patients Evaluation the Effect of extracts of Cydonia oblonga, Punica granatum and Phyllanthus emblica on the prevention of gastric and peptic ulcer disease in hospitalized burned patients at Ayatollah Taleghani hospital in Ahvaz: double blind clinical trial 2020-06-03 anticipated 60 Complete https://irct.ir/trial/47499 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The block randomization method is used Blocking is used to balance the number of samples assigned to each study group, because we have two intervention groups, use equal 4 blocks and create all 4 possible modes and then with Excel software we randomly select a number of blocks. The label of interventions to one of the letters A or B and the sequence of randomization determined by the statistical consultant. For allocation concealment, drug delivery and the sequence of randomization is not available to researchers and evaluators while is the responsibility of the off-site individual, Blinding description: Unique codes, which is generated by the software, will be used on the drug and placebo boxes. By entering each individual into the study based on the produced sequence, the drug or placebo box in which the code is registered, will be assigned to the individual. During the research, the randomization list is held by the statistic consultant, and the participants, the project implementer and all those who participate in the measurement of the indicators will not be aware of the assigned groups. 2-3 Gastric reflux and peptic ulcer. Intervention 1: Intervention group: In addition to receiving pentoprazole, 30 ml of herbal syrup will be taken twice a day for a week. The herbal syrup includes fruit of Quince, Phyllanthus emblica and pomegranate flowers, which will be made by the researchers of the project and based on the formula of Iranian traditional medicine resources, which will be standardized based on pectin, tannins and phenolic content. Intervention 2: Control group: In addition to pentoprazole, they will receive 30 ml of placebo twice a day for a week. Yes - There is a plan to make this available What will be shared: Only part of the data will be shared When: The access time is up to 6 months after the results are published To whom: Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis. Conditions: Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis. Where to obtain: Applicants can email the responsible author to receive the requested data golfakhrabadi@yahoo.com How to obtain: Applicants will have access to the data from the present study by emailing the responsible author for up to one month. Comments:
public Fereshteh golfakhrabadi
Ahvaz Jundishapur University of Medical Sciences, Golestan street
Ahvaz Iran (Islamic Republic of) 6135733184 +98 61 3373 8378 golfakhrabadi@yahoo.com Ahvaz University of Medical Sciences scientific Fereshteh golfakhrabadi
Ahvaz Jundishapur University of Medical Sciences, Golestan street
Ahvaz Iran (Islamic Republic of) 6135733184 +98 61 3373 8378 golfakhrabadi@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years of age with a burn rate of 35% or more who are hospitalized for more than ten days. The women in the study had a negative pregnancy test No history of asthma and heart disease (heart block and heart failure) 18 years no limit Both Patients with a history of endoscopic confirmed peptic ulcer. Gasteric cancer Allergy to plants especially fruits of Quince, Phyllanthus emblica and pomegranate flowers K27 Peptic ulcer, site unspecified Prevention Prevention Intervention group: In addition to receiving pentoprazole, 30 ml of herbal syrup will be taken twice a day for a week. The herbal syrup includes fruit of Quince, Phyllanthus emblica and pomegranate flowers, which will be made by the researchers of the project and based on the formula of Iranian traditional medicine resources, which will be standardized based on pectin, tannins and phenolic content. Control group: In addition to pentoprazole, they will receive 30 ml of placebo twice a day for a week. Heartburn. Timepoint: Before and a week after the intervention. Method of measurement: questionnaire. Bloating. Timepoint: Before and a week after the intervention. Method of measurement: Gastric reflux questionnaire. Feeling of heaviness in the stomach after eating. Timepoint: Before and a week after the intervention. Method of measurement: Gastric reflux questionnaire. Early satiety. Timepoint: Before and a week after the intervention. Method of measurement: Gastric reflux questionnaire. Feeling a bitter liquid (acid) in the throat. Timepoint: Before and a week after the intervention. Method of measurement: Gastric reflux questionnaire. Belching. Timepoint: Before and a week after the intervention. Method of measurement: Gastric reflux questionnaire. The rate of drug side effects. Timepoint: During drug use. Method of measurement: Patient Report. Ahvaz University of Medical Sciences Approved 2020-04-24 Ethics committee of Ahvaz Jundishapur University of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences,, Golestan street Ahvaz Khouzestan Iran (Islamic Republic of)