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IRCT20210831052349N1 IRCT 2021-11-28 Birjand University of Medical Sciences Comparison of the effectiveness of anti-anxiety medication (buspirone and sertraline) on anxiety and gastrointestinal symptoms of functional dyspepsia patients Comparison of the effectiveness of anti-anxiety medication (buspirone and sertraline) on anxiety and gastrointestinal symptoms of functional dyspepsia patients 2021-11-21 anticipated 141 Complete https://irct.ir/trial/58974 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), buspirone (B) or antispasmodic, and Proton-pump inhibitors (PPI) (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. Data Analyzer: Data is coded to a third party (statistics expert) for analysis and the individual is unaware of the grouping. 3 Functional dyspepsia. Intervention 1: Intervention group 1 patients who are given sertraline 50 mg daily (Abidi Pharmaceutical Company made in Iran) + PPI drugs for three month. Intervention 2: Intervention group 2 patients who are given Buspirone 5 mg daily (Abidi Pharmaceutical Company made in Iran) + PPI drugs for three month. Intervention 3: Control group: patients who are given antispasmodic medication daily (Moburin with a dose of 135 mg made by Ramopharmin Company of Iran) and symptomatic treatment of diarrhea or constipation for three month. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no need to publish individual patient information
public Hajar Rahmani Firoozjaee
No45.13th Alley ,Moallem Bvld, Birjand
Birjand Iran (Islamic Republic of) 9717865565 +98 56 3222 8424 haajarrahmani@gmail.com Birjand University of Medical Sciences scientific Tahmine Tavakkoli
Moallem bvld, Birjand
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 56 3222 8424 tahminetavakoli93238@yahoo.com Birjand University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study after fully explaining the objectives of the research and the disadvantages and advantages of the methods not receiving psychological therapies before entering the study No alcohol and drugs Absence of danger signs such as gastrointestinal bleeding, blood in the stool, fever, weight loss, anemia, nocturnal diarrhea, severe heartburn No psychotic disorder and personality disorder Possibility to keep the type and amount of drug used during the research period if the drug is used No other organic disease Lack of other structural or functional gastrointestinal disorders 18 years 50 years Both Having psychotic disorder or other gastrointestinal disorders Existence of danger signs in the patient (such as gastrointestinal bleeding, blood in the stool, fever, weight loss, anemia, nocturnal diarrhea, severe heartburn, etc.) Having complete criteria for personality disorder K30 Functional dyspepsia Treatment - Drugs Treatment - Drugs Treatment - Other Intervention group 1 patients who are given sertraline 50 mg daily (Abidi Pharmaceutical Company made in Iran) + PPI drugs for three month. Intervention group 2 patients who are given Buspirone 5 mg daily (Abidi Pharmaceutical Company made in Iran) + PPI drugs for three month. Control group: patients who are given antispasmodic medication daily (Moburin with a dose of 135 mg made by Ramopharmin Company of Iran) and symptomatic treatment of diarrhea or constipation for three month. Anxiety score in Beck questionnaire. Timepoint: at the beggining (day 0),day 30,day 90. Method of measurement: Beck anxiety questionnaire. Upper gastrointestinal symptoms severity questionnaire PAGI-SYM. Timepoint: At the beggining (day 0), day 30, day 90. Method of measurement: 20-item PAGI-SYM symptom severity questionnaire. Birjand University of Medical Sciences Approved 2021-08-28 Ethics Committee of Birjand University of Medical Sciences No.45 ,13 Alley ,Moallem Blvd ,Birjand Birjand South Khorasan Iran (Islamic Republic of)