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

Comparison of the effectiveness of Sertraline and Nortriptyline on anxiety and gastrointestinal symptoms in patients with irritable bowel syndrome

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 192 patients. Blocking method will be used for randomization.

This study is performed in Valiasr Hospital and Bouali Birjand Clinic. 192 patients are randomly divided into three groups receiving sertraline, nortriptyline and antispasmodics. Patients' anxiety and clinical symptoms are assessed by the facilitator at the beginning and one month after the intervention.

patients referred to the subspecialty gastroenterology clinic of Bu Ali and Valiasr Hospital in 2021. Inclusion criteria: Patients between the age of 18 to 50 years and also the willingness of patients to participate and Exclusion criteria: Non-cooperation of the patient, history of gastrointestinal cancer and neurological disorders, pregnancy and lactation, bipolar or bipolar patients, contraindications to the use of both Sertraline and Nortriptyline, the use of antidepressants and anti-anxiety drugs, allergies to prescription drugs, concomitant serious physical illnesses such as heart disease, multiple sclerosis, psychosis Like schizophrenia and related disorders, it will be substance abuse and substance abuse.

Intervention groups included patients receiving Sertraline 50 mg, Nortriptyline 25 mg (Abidi Pharmaceutical Company made in Iran) or antispasmodic drug (Maburin at a dose of 135 mg made by Alhavi Company in Iran) and symptomatic treatment of diarrhea or constipation for one month They receive it on a daily basis.

Anxiety and clinical signs of patients include: bloating or abdominal distension, bowel movements such as diarrhea or constipation

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.

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.