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IRCT20190618043934N13 IRCT 2021-08-12 Birjand University of Medical Sciences Comparison of the effectiveness of sertraline and Nortriptyline on anxiety and gastrointestinal symptoms in patients with irritable bowel syndrome Comparison of the effectiveness of sertraline and Nortriptyline on anxiety and gastrointestinal symptoms in patients with irritable bowel syndrome: A double-blind clinical trial study 2021-08-06 anticipated 192 Complete https://irct.ir/trial/57729 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants in the study will be randomly divided into three intervention groups: sertraline (A), nortriptyline (B) or antispasmodic, and symptomatic treatment of diarrhea or constipation (C) using the blocking method. First, various triple blocks are created using sealed envelopes (ABC, ACB, BAC, BCA, CAB, CBA). One of these blocks is selected randomly and according to the order mentioned in the selected block, patients will be divided into one of three groups A, B or C. Then randomization is performed for other patients in the same way, Blinding description: Outcome Evaluator: The study facilitator (medical student) will perform the necessary evaluation without knowing the type of medication received by the patients and will be recorded in a checklist designed for this purpose. Patients: The patients participating in the study are not aware of their group, so the drugs are packaged in the same package and given to patients by the pharmacy. 3 irritable bowel syndrome. Intervention 1: Intervention group: The first group in the interventional study are patients who are given sertraline 50 mg daily (Abidi Pharmaceutical Company made in Iran) for one month. Intervention 2: Intervention group: The second intervention group patients who are given nortriptyline 25 mg daily (Abidi Pharmaceutical Company made in Iran) for one month. Intervention 3: Control group:The third intervention group patients who are given antispasmodic medication daily (Moburin with a dose of 135 mg made by Alhawi Company of Iran) and symptomatic treatment of diarrhea or constipation for one month. 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 need to publish individual patient information
public Zabihullah Mohaghegh
No.56, Jorjani Ave, Ghahhari Blvd, Birjand Town
Birjand Iran (Islamic Republic of) 9717934888 +98 56 3238 3232 zabihullahmohaghegh@gmail.com Birjand University of Medical Sciences scientific Dr. Tahmineh Tavakoli
Department of Internal Medicine, School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
Birjand Iran (Islamic Republic of) 9717811674 +98 56 3238 3232 oabstudent@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 to 50 years Patient consent to participate in the study 18 years 50 years Both Lack of patient cooperation to participate in further study History of gastrointestinal cancer History of neurological disorder Pregnancy and lactation Bipolar or bipolar patients Contraindications to the use of two drugs sertraline and nortriptyline Use of antidepressants and anti-anxiety drugs Allergy to prescription drugs Co-occurring with serious physical illnesses such as heart disease, multiple sclerosis Having a psychotic illness such as schizophrenia and related disorders Substance abuse and substance abuse K58 Irritable bowel syndrome Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: The first group in the interventional study are patients who are given sertraline 50 mg daily (Abidi Pharmaceutical Company made in Iran) for one month. Intervention group: The second intervention group patients who are given nortriptyline 25 mg daily (Abidi Pharmaceutical Company made in Iran) for one month. Control group:The third intervention group patients who are given antispasmodic medication daily (Moburin with a dose of 135 mg made by Alhawi Company of Iran) and symptomatic treatment of diarrhea or constipation for one month. Anxiety. Timepoint: At the beginning of the study and one month after the start of the intervention in patients. Method of measurement: Beck Anxiety Questionnaire. Birjand University of Medical Sciences Approved 2021-07-12 Ethics Committee of Birjand University of Medical Sciences Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town Birjand South Khorasan Iran (Islamic Republic of)