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IRCT20221106056416N1 IRCT 2022-12-29 Hamedan University of Medical Sciences Evaluation of the effect of Thiamine in the prevention of post-thrombotic syndrome in patients with deep vein thrombosis of the lower extremities Evaluation of the effect of Thiamine in the prevention of post-thrombotic syndrome in patients with deep vein thrombosis of the lower extremities 2022-12-06 anticipated 80 Complete https://irct.ir/trial/66829 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The initial selection of the samples is based on the eligibility criteria for entering the study. Still, the allocation of the groups to the standard treatment and the new treatment will be randomized by the method of randomization in a block of 4 and in such a way that the distribution of people will be based on Gender and age groups in two groups of standard treatment and new treatment should be homogeneous. In this method, we use blocks of 4 (double the number of study groups) with different sequences such as AABB, ABAB, etc. until the sample size is reached. The order of placement of groups in a block cannot be guessed. Everyone who enters the study will receive the chosen type of intervention (placebo or thiamine) in a randomly selected block. At the end of the study, when all the blocks are used, there will be an equal number of intervention and control samples, Blinding description: After confirming the patient's entry into the study and initial examination by the specialist, the patient is randomly assigned to one of the intervention or control groups, and the appropriate medicine is given to the patient by the supervisor without the knowledge of the evaluating specialist. The patient himself has been informed in advance that he may receive the new drug or a placebo, but which one he received will not be determined. 3 post thrombotic syndrome. Intervention 1: Intervention group: Receive 300 mg thiamine tablets daily in addition to standard DVT treatment. Intervention 2: Control group: receiving placebo in addition to standard DVT treatment. Yes - There is a plan to make this available What will be shared: All data are publishable after the de-identification of participants. When: 3 months after publication To whom: Researchers working in academic institutions Conditions: There is no prohibition Where to obtain: M.bazrafshan@umsha.ac.ir How to obtain: The data will be sent to the eligible applicant as soon as possible and within 2 weeks of the correspondence. Comments:
public Maziar Bazrafshan
Besat hospital
Hamedan Iran (Islamic Republic of) 6514845411 +98 81 3826 9335 m.bazrafshan@umsha.ac.ir Hamedan University of Medical Sciences scientific Maziar Bazrafshan
Besat hospital
Hamedan Iran (Islamic Republic of) 6514845411 +98 81 3826 9335 m.bazrafshan@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) patients Have had a first episode of isolated DVT in the iliofemoral veins within 30 days and have not taken anticoagulant therapy previously Physical status (ASA) class I and II 18 years 65 years Both I87.0 Postthrombotic syndrome Treatment - Drugs Treatment - Drugs Intervention group: Receive 300 mg thiamine tablets daily in addition to standard DVT treatment Control group: receiving placebo in addition to standard DVT treatment The amount of Villalta index score in patients with DVT in the third and sixth months after starting treatment with thiamine 300 mg daily. Timepoint: at The end of the third month and at the end of the sixth month after starting the treatment. Method of measurement: Clinical examination by a specialist based on the Villalta index. . Timepoint: . Method of measurement: . Hamedan University of Medical Sciences Approved 2022-10-22 Ethics committee of Hamedan University of Medical Sciences Fahmideh Blvd., Hamedan university of medical science Hamedan Hamadan Iran (Islamic Republic of)