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IRCT20230304057615N1 IRCT 2023-07-02 Ahvaz University of Medical Sciences Evaluation of the effect of hydroalcoholic extract of oak in patients with gastroesophageal reflux disease (GERD) Comparing the efficacy of hydroalcoholic extract of Iranian oak (germ and seed coat) with proton pump inhibitor (PPI) treatment in improving the symptoms of patients with gastroesophageal reflux 2023-09-01 anticipated 90 Complete https://irct.ir/trial/69427 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomized using block randomization method and using blocks of size 4. And the patients are divided into three groups of 30 people and blocked randomization is for the purpose of making sure that exactly equal number of participants are included in the intervention and control groups in consecutive but equal time intervals, Blinding description: Placebo ingredients will be filled in capsules of the same color and similar to the original drug, and then the drug, placebo and pantoprazole capsules (pantoprazole 40 mg capsule produced by Dorsa Daru Company) will be coded by the pharmacist and to prevent bias, all members of the treatment and research team will be unaware of the codes until the end of the research, and after the end of the treatment, the codes will be opened. N/A Gastroesophageal reflux. Intervention 1: Intervention group :First, the oaks of the Quercus Persica species will be collected from the forests of the Zagros mountains in Mal Agha village, Baghmelk city, Khuzestan province, and a sample of them will be handed over to the pharmacognosy group to determine the genus and species and obtain the herbarium code. After that, the oaks are peeled and screened for quality, and then they are dried in a suitable environment at a temperature of 30 to 40 degrees and away from sunlight. After that, the dried oak fruits are crushed and ground by a grinder machine and sent to Ibn Masowayeh plant processing plant to produce hydroalcoholic extract, and in standard and hygienic conditions, the desired extract is prepared by spray drying. and then its tannin and polyphenol percentage will be determinedŲŒ For the formulation of 200 mg capsules, which will be done in the pharmaceutical growth center under the supervision of a pharmaceutical specialist, first the powder is mixed with the permitted auxiliary substances such as Avicel and magnesium stearate homogeneously and uniformly by the Eruka machine, and then in empty capsules of zero size and They will be filled with Iran gelatin brand by filling machine. Finally, the capsules are controlled by weight and ready for using.Capsules prepared from oak fruit extract are prepared in doses of 200 mg and patients take the medicine for 1 month in two times, morning and evening. Intervention 2: Control group 1: There are patients who will take pantoprazole 40 mg for 1 month , daily and before eating breakfast. Intervention 3: Control group2: There are patients who will take a placebo for 1 month in two times, morning and evening. No - There is not a plan to make this available Justification or reason for not sharing IPD is there is no more information
public Ali Akbar Shayesteh
24 metery street, East Sahely highway
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 2922 shayeste-a@ajums.ac.ir Ahvaz University of Medical Sciences scientific Ali Akbar Shayesteh
24 metery street, East Sahely highway
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 2922 shayeste-a@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who are between 20 and 60 years old Diagnosed with gastroesophageal reflux (GERD) based on clinical symptoms (having reflux at least twice a week), diagnostic endoscopy (esophagogastroduodenoscopy) and the Los Angeles classification (grades A to D) Not taking PPI for at least 1 week before entering the study 20 years 60 years Both Patients who are infected with H. pylori in the initial diagnostic examinations and before the intervention, based on stomach biopsy or stool test Patients with coagulation disorders or GI bleeding Patients who have a history of upper GI surgery or suffer from other digestive diseases such as irritable bowel syndrome, peptic ulcer, obstructive disease, etc Patients with Zollinger-Ellison syndrome, primary motility disorders, Barrett's esophagus, esophageal stricture, and any severe disease with reflux and malignancy of the upper gastrointestinal tract, as well as pregnant or lactating women Patients who take PPIs from 28 days before diagnostic endoscopy or H2 receptor antagonists from 14 days before diagnostic endoscopy Patients who take NSAIDs or other drugs that may interfere with the interpretation of the study result. (diazepam, quinidine, Dilantin, warfarin, anticholinergics, prostaglandin analogs, or sucralfate) Patients with chronic kidney, lung, and liver diseases and ... Patients who have a history of sensitivity to pantoprazole or seasonal allergies or asthma Patients who consume alcohol or drugs K21.9 Gastro-esophageal reflux disease without esophagitis Treatment - Drugs Treatment - Drugs Placebo Intervention group :First, the oaks of the Quercus Persica species will be collected from the forests of the Zagros mountains in Mal Agha village, Baghmelk city, Khuzestan province, and a sample of them will be handed over to the pharmacognosy group to determine the genus and species and obtain the herbarium code. After that, the oaks are peeled and screened for quality, and then they are dried in a suitable environment at a temperature of 30 to 40 degrees and away from sunlight. After that, the dried oak fruits are crushed and ground by a grinder machine and sent to Ibn Masowayeh plant processing plant to produce hydroalcoholic extract, and in standard and hygienic conditions, the desired extract is prepared by spray drying. and then its tannin and polyphenol percentage will be determinedŲŒ For the formulation of 200 mg capsules, which will be done in the pharmaceutical growth center under the supervision of a pharmaceutical specialist, first the powder is mixed with the permitted auxiliary substances such as Avicel and magnesium stearate homogeneously and uniformly by the Eruka machine, and then in empty capsules of zero size and They will be filled with Iran gelatin brand by filling machine. Finally, the capsules are controlled by weight and ready for using.Capsules prepared from oak fruit extract are prepared in doses of 200 mg and patients take the medicine for 1 month in two times, morning and evening. Control group 1: There are patients who will take pantoprazole 40 mg for 1 month , daily and before eating breakfast. Control group2: There are patients who will take a placebo for 1 month in two times, morning and evening. Gastroesophageal reflux score in the health-related quality of life questionnaire. Timepoint: All patients are evaluated at the beginning of the study (before the intervention) and at the end of the first, second and fourth week. Method of measurement: Health-related quality of life questionnaire (related to GERD). Gastroesophageal reflux score in frequency scale questionnaire for symptoms. Timepoint: All patients are evaluated at the beginning of the study (before the intervention) and at the end of the first, second and fourth week. Method of measurement: The frequency scale for the symptoms questionnaire. Ahvaz University of Medical Sciences Approved 2023-03-12 Ethics Committee of Ahvaz Jundi Shapur University of Medical Sciences Jundishapur University of Medical Sciences., Esfand St., Golestan Blvd., Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)