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IRCT20201119049445N3 IRCT 2022-06-17 Esfahan University of Medical Sciences The effect of adding Pentoxifylline to common treatments in depression in bipolar patients referred to Khorshid Hospital in 1401 The effect of adding Pentoxifylline to common treatments in depression in bipolar patients 2022-06-21 anticipated 86 Complete https://irct.ir/trial/63754 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random Allocation method is used, for this purpose, the researcher first determines a total sample size and then randomly assigns a set of them to group A and the rest to group B, for example 100 Balls in group A and 100 balls in group B, then the balls are randomly removed from the container without replacement and the created sequence is recorded, Blinding description: In collaboration with the Faculty of Pharmacy of Isfahan University of Medical Sciences, drugs and placebo with the same shape, color, taste and size are produced, and a specific code is assigned to each so that both the researcher and the participants are unaware. The data are decrypted. 1-2 Depressive phase of bipolar patients type one and two. Intervention 1: Intervention group: Pentoxifylline tablets, 400 mg, one daily, in the morning, for two months, a product of Amin Pharmaceutical Company. Intervention 2: Control group: In addition to the usual treatments for placebo bipolar depression, one daily, in the morning, for two months, made by Isfahan School of Pharmacy. 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 more information
public Hajar Salimi
No 9 ، 14th Ave ، North Farabi St ، Mardavij St
Isfahan Iran (Islamic Republic of) 8168774661 +98 31 3669 6591 salimi85ha@gmail.com Esfahan University of Medical Sciences scientific Hajar Salimi
No 9، 14th Ave، North Farabi St ، Mardavij St
Isfahan Iran (Islamic Republic of) 8168774661 +98 31 3669 6591 dr.mahsa.rahimi.67@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with type 1 and 2 bipolar disorder with an age range of 18 to 60 years in the depressive phase Diagnosis of type 1 and 2 bipolar disorder based on DSM-V criteria by a psychiatrist Have at least five classes of education 18 years 60 years Both Existence of psychotic symptoms Existence of another psychiatric disorder Existence of hypothyroidism History of cardiovascular disease Pregnancy or breastfeeding Existence of hepatic failure Peptic ulcer Take antiplatelet drugs or anticoagulants Receiving non-steroidal anti-inflammatory drugs F31.3 Bipolar disorder, current episode depressed, mild or moderate severity Treatment - Drugs Treatment - Drugs Intervention group: Pentoxifylline tablets, 400 mg, one daily, in the morning, for two months, a product of Amin Pharmaceutical Company Control group: In addition to the usual treatments for placebo bipolar depression, one daily, in the morning, for two months, made by Isfahan School of Pharmacy Depression score in Bipolar Depression Rating Scale questionnaire. Timepoint: At the beginning of the study, weeks 4 and 8 of the study. Method of measurement: Bipolar Depression Rating Scale questionnaire. Quality of life score. Timepoint: Before the study, weeks 4 and 8 after the study. Method of measurement: 20-item BDRS questionnaire. Esfahan University of Medical Sciences Approved 2022-04-28 Ethics Committee of Isfahan University of Medical Sciences No 9 ،Jordan building، 14th Ave، North Farabi St، Mardavij St Isfahan Isfehan Iran (Islamic Republic of)