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IRCT20211214053405N1 IRCT 2022-01-01 Babol University of Medical Sciences Evaluation of the effect of Pistacia atlantica oleoresin on Irritable bowel syndrome Evaluation of the effect of Pistacia atlantica oleoresin on clinical symptoms of the patients with Irritable bowel syndrome with constipation predominance 2022-01-15 anticipated 70 Complete https://irct.ir/trial/60781 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by permuted block randomization method and concealment is done. Patients are divided into two groups using the above method. Six of the four combinations of intervention groups A and B are determined AABB ABAB ABBA ABBA BBAA BABA BAAB and randomly select each of the above combinations and those who agree to participate in the study are placed in study groups, Blinding description: In this study, blinding will be double-blind. In this way, patients will not be aware of their position in the two groups and the drug and placebo will be prepared in identical forms (in terms of color, smell, and taste) in the form of capsules for both groups. P. atlantica oleoresin capsules are delivered to the intervention group, and placebo capsules containing starch are delivered to the control group. The researcher responsible for collecting the initial data and the outcomes will not be aware of the type of drug the patients are taking. 3 Irritable bowel syndrome. Intervention 1: Intervention group: P.atlantica oleoresin capsule (Saqez) and placebo are prepared by a pharmacist in the traditional pharmacy laboratory of the Faculty of Traditional Medicine of Babol University of Medical Sciences. oleoresin is prepared in capsules weighing 500 mg. Tests are performed to control microbial and chemical analysis of the essential oil. Both drug and placebo are packaged in similar containers. The drug is taken twice a day for six weeks. Intervention 2: Control group: The placebo capsule is prepared by a pharmacist in the traditional pharmacy laboratory of the Faculty of Traditional Medicine of Babol University of Medical Sciences. The placebo capsules are filled with cornstarch (weighing 500 mg). Tests to control microbial contamination are performed. Both products are packaged in similar containers. To match the odor, placebo capsules are placed for a while in an area adjacent to P.atlantica essential oil. The placebo is taken twice a day for six weeks. 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 The decision is made after negotiations with the sponsor
public Amir Adibifard
Ganjafrooz st
Babol Iran (Islamic Republic of) 4717647745 +98 21 7790 8363 Amiradibifard@yahoo.com Babol University of Medical Sciences scientific Narjes Gorji
Ganjafrooz
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 4730 N.gorji@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) The patient has not been treated with Pistacia atlantica oleoresin for the past month Patients with IBS whose type of disease has been confirmed by a complete medical examination. The patient signs a written consent Age over 18 years 18 years no limit Both Pregnant or lactating women Patients with malignancies or other chronic gastrointestinal diseases such as inflammatory bowel disease and celiac disease History of major gastrointestinal surgery (including Billroth surgery, ostomy, and any resection in any part of the gastrointestinal tract). Inability to swallow capsules People taking psychotherapy drugs Patients at a serious health risk, including severe heart, liver or kidney disease Patients with severe plant allergies Regular use of drugs that change the movement of the gastrointestinal tract such as metoclopramide, cisapride, drugs, diphenoxylate, etc. Regular use of laxatives Follow the diet plans with daily and regular intake of prebiotic/probiotic compounds Taking antibiotics The patient has been treated with Pistacia atlantica for the past month Cigarette smoking, alcohol usage NSAID usage K58.9 Irritable bowel syndrome without diarrhea Treatment - Drugs Placebo Intervention group: P.atlantica oleoresin capsule (Saqez) and placebo are prepared by a pharmacist in the traditional pharmacy laboratory of the Faculty of Traditional Medicine of Babol University of Medical Sciences. oleoresin is prepared in capsules weighing 500 mg. Tests are performed to control microbial and chemical analysis of the essential oil. Both drug and placebo are packaged in similar containers. The drug is taken twice a day for six weeks. Control group: The placebo capsule is prepared by a pharmacist in the traditional pharmacy laboratory of the Faculty of Traditional Medicine of Babol University of Medical Sciences. The placebo capsules are filled with cornstarch (weighing 500 mg). Tests to control microbial contamination are performed. Both products are packaged in similar containers. To match the odor, placebo capsules are placed for a while in an area adjacent to P.atlantica essential oil. The placebo is taken twice a day for six weeks. Change in the severity of irritable bowel syndrome based on the total score of the IBS-SSS scale. Timepoint: The beginning of the study and the sixth week of the intervention and one month after the intervention. Method of measurement: Irritable Bowel Syndrome Severity Questionnaire (IBS-SSS). Quality of life based on change in total score of IBS-QOL quality of life questionnaire, change in symptoms of IBS-SSS Irritable Bowel Syndrome Scale. Timepoint: Initially study and the sixth week of intervention and one month after intervention. Method of measurement: Quality of Life Questionnaire for Patients with Irritable Bowel Syndrome (IBS-QOL). The severity of symptoms subsets of the IBS-SSS Irritable Bowel Syndrome questionnaire. Timepoint: Initially study and the sixth week of intervention and one month after intervention. Method of measurement: IBS-SSS questionnaire. Babol University of Medical Sciences Approved 2021-10-06 Ethics committee of Babol University of Medical Sciences Babol ganjafrooz st Babol Mazandaran Iran (Islamic Republic of)