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IRCT20211226053534N2 IRCT 2023-08-12 Islamic Azad University Evaluation of Vitamin B6 (pyridoxine) Effect on symptoms and quality of life in patients with irritable bowel syndrome (IBS) PIBS Evaluation of Vitamin B6 (pyridoxine) Effect on symptoms and quality of life in patients with irritable bowel syndrome (IBS) 2023-09-06 anticipated 60 Complete https://irct.ir/trial/71888 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the two study arms and three categories of IBS (predominant constipation, diarrhea, or mixed) diagnosed using the Rome IV criteria, a randomization list is created using an online randomization software in blocks of six. Through this method, a unique code is generated for each individual. Each code, along with the medication category A or B, is placed in a sealed envelope. Upon the individual's entry into the study and in the order specified by the randomization list, the envelope is opened by the diagnosing physician, and the patient is randomly assigned to either the treatment group receiving drug A or drug B. Both the physician and the patient are blinded to the content of drugs A and B. The patient is provided with the assigned medication code, and they receive a bottle of medication from category A or B from the pre-determined pharmacy, which holds these bottles, Blinding description: Until the end of data collection, only the pharmacist will be aware of the content of drugs A and B, and until that time, all participants and researchers will remain blinded. 2 Irritable bowel syndrome. Intervention 1: Intervention group: Vitamin B6 (pyridoxine) tablet, 40 mg, every 12 hours for a duration of four weeks. Intervention 2: Control group: Placebo tablet, 40 mg, every 12 hours for a duration of four weeks. Yes - There is a plan to make this available What will be shared: The non-identifiable statistical data of the participants will be shared collaboratively. When: Access will be provided upon publication of the relevant study articles. To whom: Researchers at scientific institutions. Conditions: Studies in the field of irritable bowel syndrome. Where to obtain: To receive the documents via email, please send your request and the reason for it to person responsible for general inquiries of the study. After reviewing it in the shortest possible time, a response to your request will be sent. Email address: dpusaz@gmail.com How to obtain: Through email. dousaz@gmail.com Comments:
public Mohammad Mahdi Azizian
Dr. Shahinfar Medical Faculty; Islamic Azad University Of Mashhad, Imam Khomeini 14, Imam Khomeini St
Mashhad Iran (Islamic Republic of) 9178673799 +98 991 455 3005 dpusaz@gmail.com Islamic Azad University scientific Elham Mokhtari Amirmajdi
Dr. Shahinfar Medical Faculty; Islamic Azad University Of Mashhad, Imam Khomeini 14, Imam Khomeini St
Mashhad Iran (Islamic Republic of) 9178673799 +98 915 316 5096 Emokhtaria@gmail.com Islamic Azad University Iran (Islamic Republic of) Newly diagnosed patients with Irritable Bowel Syndrome (IBS) according to the Rome IV criteria Age from 18 to 65 years old 18 years 65 years Both Personal History of malignant diseases of the gastrointestinal tract, Celiac disease, Lactose intolerance, Diverticulitis, Gastrointestinal infection, Hypothyroidism and hyperthyroidism Presence of other diseases during colonoscopy in individuals over 50 years of age Pregnancy and lactation Allergy to the study drug Lack of consent to participate in the study K58 Irritable bowel syndrome Treatment - Drugs Placebo Intervention group: Vitamin B6 (pyridoxine) tablet, 40 mg, every 12 hours for a duration of four weeks. Control group: Placebo tablet, 40 mg, every 12 hours for a duration of four weeks. Irritable bowel syndrome severity. Timepoint: At beginning of the study and four weeks after initiation of the study. Method of measurement: The irritable bowel severity scoring system (IBSSS). Quality of life in patients with irritable bowel syndrome. Timepoint: At beginning of the study and four weeks after initiation of the study. Method of measurement: Irritable bowel syndrome quality of life questionnaire (IBS-QOL). Islamic Azad University Approved 2023-07-19 Research Ethics Committees of Mashhad Medical Science Islamic Azad University Dr. Shahinfar Medical Faculty; Islamic Azad University Of Mashhad, Imam Khomeini 14, Imam Khomeini St Mashhad Razavi Khorasan Iran (Islamic Republic of)