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IRCT20210423051046N1 IRCT 2022-01-05 Tabriz University of Medical Sciences The effect of pomegranate peels extract on clinical symptoms of patients with irritable bowel syndrome The Effect of Pomegranate peel extract on clinical symptoms ,stool calprotectin level and quality of life in patients with diarrhea-dominant irritable bowel syndrome : A double-blind randomized placebo-controlled clinical trial 2021-05-31 anticipated 62 Complete https://irct.ir/trial/55857 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using Graph pad software, so that the groups will be marked with two letters A and B. And then the software will assign each person to one of the groups A and B. This list will be prepared by one of the researchers who has no role in the other parts of the study and will be hidden from the others until the end of the study, Blinding description: For blinding, medicine and placebo are prepared in similar packages and one of the colleagues will use labels A and B for differentiation and none of the researchers as well as patients will be aware of the contents of A and B until the end of statistical analysis. 3 Irritable bowel syndrome. Intervention 1: Intervention group: This group, which consisting of 31 patients with irritable bowel syndrome and randomly selected, will receive two 250 mg capsules containing pomegranate peel extract daily for two months. These capsules are extracted from pomegranate peel by ethanolic extraction method. Questionnaires about changes in clinical symptoms and changes in their quality of life as well as fecal calprotectin levels will be assessed before the intervention and after the intervention. Intervention 2: Control group: This group, which consisting of 31 patients with irritable bowel syndrome and randomly selected, will receive two 250 mg placebo capsules daily for two months. These capsules are exactly the same shape and size as the capsules of the intervention group. Questionnaires about changes in clinical symptoms and changes in their quality of life as well as fecal calprotectin levels will be assessed before the intervention and after the intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Fatemeh Javan Ali Azar
No. 6, 5th Floor, B block, Shafagh Tower, Ghanoon St, Valiasr St, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5157714119 +98 41 3320 1309 Fateme.javan88@gmail.co Tabriz University of Medical Sciences scientific Fatemeh Javan Ali Azar
No. 6, 5th floor, B block, Shafagh Tower, Ghanoon St, Valiasr St
Tabriz Iran (Islamic Republic of) 5157714119 +98 41 3320 1309 Fateme.Javan88@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Irritable bowel syndrome patients with diarrhea dominant symptom 18 years no limit Both K58 Irritable bowel syndrome Treatment - Drugs Placebo Intervention group: This group, which consisting of 31 patients with irritable bowel syndrome and randomly selected, will receive two 250 mg capsules containing pomegranate peel extract daily for two months. These capsules are extracted from pomegranate peel by ethanolic extraction method. Questionnaires about changes in clinical symptoms and changes in their quality of life as well as fecal calprotectin levels will be assessed before the intervention and after the intervention. Control group: This group, which consisting of 31 patients with irritable bowel syndrome and randomly selected, will receive two 250 mg placebo capsules daily for two months. These capsules are exactly the same shape and size as the capsules of the intervention group. Questionnaires about changes in clinical symptoms and changes in their quality of life as well as fecal calprotectin levels will be assessed before the intervention and after the intervention. Score of clinical symptoms in first questionnaire. Timepoint: Before the intervention and 2 months after the beginning of intervention. Method of measurement: The second questionnaire. Stool calprotectin level. Timepoint: Before the intervention and 2 months after the beginning of intervention. Method of measurement: Measured by the laboratory. Quality of life. Timepoint: Before the intervention and 2 months after the beginning of intervention. Method of measurement: Quality of Life Questionnaire for Patients with Irritable Bowel Syndrome. Tabriz University of Medical Sciences Approved 2020-10-05 Ethics committee of Tabriz university of medical science Deputy of Research and Technology, 3th floor, Central building NO. 2, Tabriz University of Medical Sciences, Golgasht St, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)