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IRCT20210829052320N1 IRCT 2022-02-24 Mashhad University of Medical Sciences Effect of probiotics onthyroid function and fatigue score in patients with hypothyroidism Effect of probiotics on thyroid function and fatigue score in patients with hypothyroidism 2022-04-21 anticipated 80 Complete https://irct.ir/trial/58503 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization will be used as a reliable randomization method that leads to a balanced allocation of individuals in treatment groups at the end of each block. For this purpose, an online website addressed as (https://www.sealedenvelope.com/simple-randomiser/v1/lists) is used to create random blocks with different sizes depending on the total sample and proposed block sizes (4 and 6). Each block content is sealed. One of the block is randomly chosen when a patient refers. The patient is assigned to one of the study arms depending on the block content. Similarly, after the completion of the first block, the second block is randomly selected and this continues until the last block and the last patient is assigned to the study arms. By assigning the last sheet of the last block, the patients are grouped equally in the two study arms, Blinding description: After entering the study, patients choose a card from the secretary. They will receive placebo for even numbers and intervention medication for odd numbers. The secretary will enter the code in the form of each patient's form so the researcher and the participant will not be aware of the meaning of the code. Codes will be reserved until the end of the study and data analysis. The drug and placebo will be placed in the same boxes so the patients can not understand which are drug or placebo. 3 Hypothyroidism. Intervention 1: Intervention group: Lactocar 500 mg probiotic capsules once a day for 12 weeks. Intervention 2: Control group: 500mg placebo capsules for 12 weeks, 1 capsule daily. 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 Mina Akbari Rad
Ghaem Hospital, Ahmadabad St., Mashhad, Khorasan Razavi
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2370 akbariradm@mums.ac.ir Mashhad University of Medical Sciences scientific Mina Akbari Arad
Ghaem Hospital, Ahmadabad St., Mashhad, Khorasan Razavi
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2370 akbariradm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Hypothyroid or subclinical hypothyroid patient with treatment indication At least 3 month on levothyroxine Euthyroid during this 3month 18 years 65 years Both Recent thyroidectomy Using Antibiotics in last 3 month Being Alcohol user or smoker Being peregnant or breastfeeding Using drugs lowering levothyroxine consumption Changing levothyroxine doses during follow up time E03.8 Central hypothyroidism Treatment - Drugs Placebo Intervention group: Lactocar 500 mg probiotic capsules once a day for 12 weeks Control group: 500mg placebo capsules for 12 weeks, 1 capsule daily Serum TSH levels. Timepoint: Before the intervention and after 12 weeks of medication. Method of measurement: blood test. Serum free T4 levels. Timepoint: Before the intervention and after 12 weeks of medication. Method of measurement: Blood test. Serum free T3 levels. Timepoint: Before the intervention and after 12 weeks of medication. Method of measurement: Blood test. Mashhad University of Medical Sciences Approved 2021-05-11 Ethics committee of Mashhad University of Medical Sciences Faculty of Medicine, east door of Ferdowsi University campus, Azadi Square mashhad Razavi Khorasan Iran (Islamic Republic of)