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IRCT20250502065563N4 IRCT 2026-10-31 Dezfoul University of Medical Sciences Effect of taurine in patients with hyperthyroidism Evaluation of the effect of taurine in patients with hyperthyroidism treated with methimazole: A two-group randomized placebo-controlled clinical trial 2026-12-22 anticipated 60 Pending https://irct.ir/trial/94105 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 60 eligible patients will be randomly allocated in a 1:1 ratio to the intervention and control groups after obtaining informed consent and completing methimazole stabilization. The unit of randomization will be the individual patient. An independent individual will generate the random allocation sequence using computer-generated random numbers. Variable block randomization will be used. No stratification is planned. The allocation list will remain confidential, and group assignments must be concealed from the person enrolling participants until each patient is assigned, Blinding description: Participants, outcome assessors, and the statistical analyst will be blinded to treatment allocation. Taurine and placebo capsules will be identical in appearance, color, size, and packaging and will be coded. Allocation codes will remain confidential until completion of the final data analysis. 2 Hyperthyroidism. Intervention 1: Intervention group (n=30): Participants will receive oral taurine capsules at a dose of 500 mg once daily, 1–2 hours before bedtime, for four consecutive weeks, in addition to standard methimazole therapy at a daily dose of 10–20 mg. The intervention will begin after at least four weeks of methimazole treatment. Intervention 2: Control group (n=30): Participants will receive methimazole at a daily dose of 10–20 mg along with placebo capsules identical to taurine in appearance, color, size, and packaging. The placebo will be administered once daily, 1–2 hours before bedtime, for four consecutive weeks. 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 further information.
public Ali Akbar Oroojan
School of Medicine, Dezful University of Medical Sciences, Azadegan Street, Dezful, Khuzestan Province, Iran.
Dezful Iran (Islamic Republic of) 6461653476 +98 61 4242 2710 aliakbar_oroojan@yahoo.com Dezfoul University of Medical Sciences scientific Ali Akbar Oroojan
School of Medicine, Dezful University of Medical Sciences, Azadegan Street, Dezful, Khuzestan Province, Iran.
Dezful Iran (Islamic Republic of) 6461653476 +98 61 4242 2710 aliakbar_oroojan@yahoo.com Dezfoul University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 60 years. Clinically and laboratory-confirmed hyperthyroidism. Receiving methimazole at a daily dose of 10–20 mg. At least four weeks since initiation of methimazole treatment. No use of taurine or other amino acid supplements during the previous four weeks. No regular use of sedatives, hypnotics, or medications affecting the central nervous system. Ability to complete the study questionnaires. Provision of written informed consent. 18 years 60 years Both Presence of severe liver, kidney or heart disease at screening. Pregnancy at screening. E05 Thyrotoxicosis [hyperthyroidism] Treatment - Drugs Placebo Intervention group (n=30): Participants will receive oral taurine capsules at a dose of 500 mg once daily, 1–2 hours before bedtime, for four consecutive weeks, in addition to standard methimazole therapy at a daily dose of 10–20 mg. The intervention will begin after at least four weeks of methimazole treatment. Control group (n=30): Participants will receive methimazole at a daily dose of 10–20 mg along with placebo capsules identical to taurine in appearance, color, size, and packaging. The placebo will be administered once daily, 1–2 hours before bedtime, for four consecutive weeks. The primary outcome is the change in anxiety score measured using the seven-item Generalized Anxiety Disorder questionnaire at baseline and after four weeks of intervention, with changes compared between the two groups. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: The seven-item Generalized Anxiety Disorder questionnaire, with scores ranging from 0 to 21; higher scores indicate greater anxiety severity. Change in sleep quality score assessed using the Pittsburgh Sleep Quality Index. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Pittsburgh Sleep Quality Index questionnaire, with scores ranging from 0 to 21; higher scores indicate poorer sleep quality. Change in mean fatigue severity score assessed using the Fatigue Severity Scale. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Fatigue Severity Scale consisting of nine items rated on a seven-point scale; the final score is the mean of the nine item scores. Change in serum cortisol concentration. Timepoint: At baseline and at the end of the fourth week, between 7:00 and 9:00 AM. Method of measurement: Measurement of serum cortisol concentration after 8–12 hours of fasting using the enzyme-linked immunosorbent assay or a standard laboratory method. Changes in serum thyroid-stimulating hormone, free thyroxine, and triiodothyronine levels. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of serum thyroid hormone concentrations using the enzyme-linked immunosorbent assay. Changes in systolic and diastolic blood pressure. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of systolic and diastolic blood pressure using a calibrated digital blood pressure monitor after at least five minutes of seated rest. The mean of two consecutive measurements will be recorded in millimeters of mercury. Change in heart rate measured in beats per minute. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of heart rate using a calibrated digital blood pressure monitor after at least five minutes of seated rest. Changes in serum alanine aminotransferase and aspartate aminotransferase activities. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of liver enzyme activities using standard enzymatic colorimetric assays and an automated biochemistry analyzer. Changes in complete blood count parameters. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of complete blood count parameters using an automated hematology analyzer. Change in serum C-reactive protein concentration. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of serum C-reactive protein concentration using a standard laboratory assay. Dezfoul University of Medical Sciences Approved 2026-10-07 Ethics committee of Dezful University of Medical Sciences Khuzestan Province, Dezful, End of Azadegan Boulevard, Next to the Traffic Police Department, Iran Dezful Khouzestan Iran (Islamic Republic of)