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IRCT20210724051972N1 IRCT 2022-12-29 Birjand University of Medical Sciences Investigation of the effectiveness of Buspirone and Mirtazapine on functional dyspepsia Investigation of the effectiveness of anti-anxiety medication (Buspirone and Mirtazapine) on anxiety and gastrointestinal symptoms of functional dyspepsia patients with postprandial discomfort syndrome 2021-11-01 anticipated 120 Complete https://irct.ir/trial/58676 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: method of randomization: block unit of randomization: Number of patients In this study, the randomized block method is used as six blocks with equal proportions of groups (36 different permutations - abcabc, abcacb, abcbca, ..., cabcab) from one to thirty-six numbering and then random selection of blocks are performed using the production of a random number between 1 and 36 The packages are printed and placed in separate envelopes, and according to the order of the person who provides the drug, she provides the desired letter from the drug group or the pharmaceutical form. In this study, we will use the restricted randomization method (blockrandomization). Blocking is usually used in order to create a balance in the number of samples allocated to each of the study groups. This feature helps the researchers so that the number of samples allocated to each of the studied groups is equal. The size of all the blocks is equal and we will have 6 blocks in this three-group experiment. The randomization tool is also from the production software. Random allocation software is used. In addition to simple randomization, these random sequence generation softwares are capable of generating random sequences using the blocking method. For concealment, we use allocation concealment, which is the method used. It refers to the implementation of random sequence on the participants in the study, so that the allocated group is not known before the allocation of the individual. By using opaque sealed envelopes with random sequence (Sequentially numbered, sealed, opaque envelopes). In this method, each of the random sequences created is recorded on a card and the cards are placed in the letter envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of the participants, based on the order in which the eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: The participants do not know which treatment they will receive, and the referring physician also does not know about the assigned treatment. The person interviewing the patients does not know about the treatment received by the patients. Random allocation list that uses the software Random Allocation Software is produced in random permutation blocks and is available to the assistant, based on which the drugs will be allocated to the diseases in order. It will be explained to the participants that they are in a study and the groups will be introduced and mentioned that they will be randomly assigned to one of the groups. By using opaque sealed envelopes with random sequence (Sequentially numbered, sealed, opaque envelopes). In this method, each of the random sequences created is recorded on a card and the cards are placed in the letter envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of the participants, based on the order in which the eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. 2-3 Functional dyspepsia. Intervention 1: Intervention group: First - Buspirone receiving group with a dose of 5 mg three times a day for three months (Buspirax-brand name, Tehrandaroo factory). Intervention 2: Control group: First - group receiving Pantoprazole at a dose of 40 mg daily for three months(Nolpaza-brand name, Actoverco). Intervention 3: Intervention group: Second - the group receiving Mirtazapine at a dose of 7.5 mg nightly for three months (Mirtazapine-brand name). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Dr Tahmineh Tavakoli
Ghaffari St., Valiasr Hospital
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 56 3243 6200 tahminetavakoli93238@yahoo.com Birjand University of Medical Sciences scientific Mahdieh Khorashadizade
Ghaffari St., Central Organization of Birjand University of Medical Sciences
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 56 3239 5000 khorashadi.m@yahoo.com Birjand University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study after explaining all the objectives of the research and the advantages and disadvantages of the methods Failure to receive psychological treatment before entering the study Lack of other structural or functional gastrointestinal disorders No other organic disease Possibility to keep the type and amount of drug used during the research period if the drug is used No alcohol and drugs No psychotic disorder and personality disorder Absence of alarm signs such as gastrointestinal bleeding, blood in the stool, fever, weight loss, anemia, nocturnal diarrhea, severe heartburn Age between 18 and 50 years 18 years 50 years Both K30 Functional dyspepsia,Mirtazapine,Buspirone,Anxiety Treatment - Drugs N/A Treatment - Drugs Intervention group: First - Buspirone receiving group with a dose of 5 mg three times a day for three months (Buspirax-brand name, Tehrandaroo factory) Control group: First - group receiving Pantoprazole at a dose of 40 mg daily for three months(Nolpaza-brand name, Actoverco) Intervention group: Second - the group receiving Mirtazapine at a dose of 7.5 mg nightly for three months (Mirtazapine-brand name) The severity of dyspepsia symptoms in the three groups receiving buspirone, mirtazapine and the control group. Timepoint: The severity of dyspepsia symptoms in the three groups receiving buspirone, mirtazapine before the intervention and one month after the intervention and three months after the intervention and in the control group before the intervention and one month after the intervention. Method of measurement: patient assessment of upper gastrointestinal symptom severity index questionnaire(pagi-sym). Beck anxiety score in three groups receiving buspirone, mirtazapine and control group. Timepoint: Determining and comparing the mean score of Beck anxiety in the two groups receiving buspirone, receiving mirtazapine before the intervention, one month after the intervention and three months after the intervention and in the control group before the intervention and one month after the intervention. Method of measurement: Beck Anxiety Questionnaire. Birjand University of Medical Sciences Approved 2021-09-14 Ethics committee of Birjand University of Medical Sciences Ghafari Ave, Birjand university of medical sciences, Birjand city Birjand South Khorasan Iran (Islamic Republic of)