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

Evaluation of the effect of syrup, including Quince, pomegranate and Phyllanthus emblica in the prevention of gastroesophageal reflux disease and peptic ulcer in hospitalized burned patients at Ayatollah Taleghani Hospital in Ahvaz

Clinical trial of phase 2-3 with control and intervention groups, with parallel groups, double blind, randomized

This study will be performed by clinical trial on patients over 18 years of age with a burn rate of 35% and above who refer to Taleghani Hospital in Ahvaz. Patients will receive daily treatment (pentoprazole 80 mg daily). These patients are randomly will be divided into two groups, who accidentally will receive a bottle containing the drug or herbal syrup. The unique code provided by the software will be used on pharmaceutical boxes. Symptoms related to gastroesophageal reflux disease will be measured before and after the intervention using the questionnaire. This questionnaire has thirteen questions. These cases are scored between 0 and 4 by the subjects. Higher scores on reflux are more severe.

Inclusion criteria: 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 Exclusion criteria: Patients with a history of endoscopic confirmed peptic ulcer. Gasteric cancer, Allergy to plants especially fruits of Quince, Phyllanthus emblica and pomegranate flowers

Patients are randomly will be divided into two groups. In addition to receiving pentoprazole daily, the test and control groups will receive 30 ml of herbal syrup or placebo twice a day for a week.

Heartburn; Feeling bloated; Early satiety; Belching; Feeling of heaviness in the stomach after eating; Feeling a bitter liquid in the throat

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.

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

Only part of the data will be shared

The access time is up to 6 months after the results are published

Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis.

Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis.

Applicants can email the responsible author to receive the requested data golfakhrabadi@yahoo.com

Applicants will have access to the data from the present study by emailing the responsible author for up to one month.