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IRCT20220104053626N5 IRCT 2023-01-24 Tabriz University of Medical Sciences The effect of combination of Descurainia Sophia and Deracocephalum syrup on patients with irritable bowel syndrome with constipation The effect of combination of Descurainia Sophia and Deracocephalum syrup on clinical symptoms and quality of life in patients with irritable bowel syndrome with predominant constipation 2023-02-20 anticipated 90 Complete https://irct.ir/trial/68078 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: From the patients who volunteered to participate in the study, 90 persons will be selected by simple random sampling. Randomization method:block Randomization unit : Individual Randomization layers: In each block, people will be matched based on age and gender. Random Allocation software: Random Allocation software How to create a random sequence: Using Random Allocation software Hide: The random sequence created is kept in a safe place and is done by an independent person who is not involved in the experiment during the study. Random allocation of hidden individuals, patients and researchers will not be aware of it, Blinding description: This study is a double-blind study in which the researcher of this study and the patients participating in the study will be unaware of the type of syrup received. Syrups will be provided to patients by another person who has no role in completing the questionnaire and following patients. Patients will also be informed of the existence of two types of syrups (placebo syrup and combination of Descurainia Sophia and Deracocephalum syrup ) when obtaining consent, but will be unaware of which study groups they will be included in. Descurainia Sophia and Deracocephalum syrups are similar in appearance color, and size to placebo syrups. 2-3 irritable bowel syndrome. Intervention 1: Intervention group: Patients in the intervention group will take 10cc of Descurainia sophia and Dracocephalum syrup(manufactured by Tabriz Traditional Medicine Center) daily for one month. Intervention 2: Control group: patients in the control group will take 10cc of placebo syrup (manufactured by Tabriz Traditional Medicine Center)daily for one month. No - There is not a plan to make this available Justification or reason for not sharing IPD is no more information
public Masood faghih Dinevari
Internal medicine department,Emam reza hospital,golgasht avenue,Daneshgah street
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 dinvarim@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Masood Faghih Dinevari
Internal medicine department,Emam reza hospital,golgasht avenue,Daneshgah street
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 dinvarim@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) having IBS according to ROME IV criteria age above 18 having normal colonoscopy within 5 years willing to participate 18 years 75 years Both pregnancy and lactation any history of drug reaction celiac disease recent use of probiotics,laxatives,antibiotics and anti inflammatory drugs such as NSAID and corticosteroides. history of inflammatory bowel disease( ulcerative colitis and crohn disease) any pathologic findings in colonoscopy K58.9 Irritable bowel syndrome without diarrhea Treatment - Drugs Placebo Intervention group: Patients in the intervention group will take 10cc of Descurainia sophia and Dracocephalum syrup(manufactured by Tabriz Traditional Medicine Center) daily for one month. Control group: patients in the control group will take 10cc of placebo syrup (manufactured by Tabriz Traditional Medicine Center)daily for one month. Patients quality of life. Timepoint: Before and after the intervention. Method of measurement: The quality of life questionnaire for patients with irritable bowel syndrome. Stool stiffness. Timepoint: before and after intervention. Method of measurement: Patient Assessment of Constipation–Symptom(PAC-SYM) questionnaire. Tabriz University of Medical Sciences Approved 2022-12-26 Ethics committee of Tabriz University of Medical Sciences Ethics committee,vice chancellor for research,Faculty of medicine,Tabriz Univarsity of Medical Sciences,Golgasht st,Tabriz,Iran Tabriz East Azarbaijan Iran (Islamic Republic of)