]>
IRCT20250502065563N2 IRCT 2026-10-15 Dezfoul University of Medical Sciences Evaluation of the effect of L-theanine in patients with hyperthyroidism Evaluation of the effect of L-theanine 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/94065 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 group (L-theanine plus methimazole) or the control group (placebo plus methimazole) after obtaining informed consent and completing the methimazole stabilization period. The unit of randomization will be the individual patient. Randomization will be performed using variable block sizes of 4 and 6. An independent individual, not involved in trial implementation, will generate the allocation sequence using computer-generated random numbers. Both the order of block sizes and treatment assignments within each block will be randomized. No stratification will be applied. According to the generated sequence, identical-appearing packages containing L-theanine or placebo will be prepared and sequentially numbered from 1 to 60. The principal investigator will be aware of the package contents but will not participate in patient enrollment or allocation. The research assistant responsible for enrollment and dispensing will assign the next sequentially numbered package only after confirming eligibility and obtaining informed consent. This assistant will have no access to the allocation sequence or package contents, thereby maintaining allocation concealment until assignment, Blinding description: In this study, the principal investigator will be responsible for preparing the L-theanine supplement and the placebo, coding the packages for each group, and will be aware of the intervention type. The L-theanine supplement and placebo will be provided to a research associate in identical packages bearing specific codes, with no indication of the intervention type. This research associate will be responsible for delivering the packages to patients, collecting data, and assessing study outcomes, without knowledge of the package contents or the intervention assigned to the patients. Furthermore, the participants and the treating physician will remain unaware of whether the L-theanine supplement or the placebo is being administered. The codes corresponding to the intervention type will be retained by the principal investigator, and the allocation code will be disclosed only if medically necessary to ensure patient safety. Thus, blinding will be maintained for the participants, the treating physician, and the research associate responsible for intervention delivery, data collection, and outcome assessment, while the principal investigator remains aware of the group allocations. N/A Hyperthyroidism. Intervention 1: Control group: Participants in this group (n=30) will receive standard methimazole therapy at a daily dose of 10–20 mg as prescribed by their physician. They will also receive an oral placebo matched to L-theanine in appearance, color, size, and packaging, once daily, 1–2 hours before bedtime, for four consecutive weeks. Placebo administration will begin at least four weeks after initiation of methimazole treatment. Intervention 2: Intervention group: Participants in this group (n=30) will receive oral L-theanine supplementation at a dose of 200 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 as prescribed by their physician. Supplementation will begin at least four weeks after initiation of methimazole treatment. 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, 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, 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 18 to 60 years Definitive diagnosis of hyperthyroidism based on American Thyroid Association (ATA) clinical and laboratory criteria Treatment with methimazole at a dosage of 10 to 20 mg/day At least four weeks of methimazole treatment prior to the start of the intervention No use of amino acid supplements containing L-theanine within the last four weeks No regular use of sedatives, hypnotics, or medications affecting the central nervous system Ability to complete the study questionnaires Written informed consent to participate in the study 18 years 60 years Both Pregnancy Suffering from severe liver, kidney, or heart disease Use of drugs affecting the central nervous system Reluctance to take supplements E05 Thyrotoxicosis [hyperthyroidism] Placebo Treatment - Drugs Control group: Participants in this group (n=30) will receive standard methimazole therapy at a daily dose of 10–20 mg as prescribed by their physician. They will also receive an oral placebo matched to L-theanine in appearance, color, size, and packaging, once daily, 1–2 hours before bedtime, for four consecutive weeks. Placebo administration will begin at least four weeks after initiation of methimazole treatment. Intervention group: Participants in this group (n=30) will receive oral L-theanine supplementation at a dose of 200 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 as prescribed by their physician. Supplementation will begin at least four weeks after initiation of methimazole treatment. Change in anxiety score measured using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Timepoint: At baseline (before the intervention) and at the end of the fourth week after initiation of L-theanine supplementation or placebo administration. Method of measurement: The seven-item Generalized Anxiety Disorder questionnaire, with a total score ranging from 0 to 21, where 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 a total score 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 calculated as 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 in venous blood using the enzyme-linked immunosorbent assay or the standard method employed by the central laboratory. Change in serum thyroid-stimulating hormone concentration. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of serum thyroid-stimulating hormone concentration using the enzyme-linked immunosorbent assay. Change in serum free thyroxine concentration. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of serum free thyroxine concentration using the enzyme-linked immunosorbent assay. Change in serum triiodothyronine concentration. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of serum triiodothyronine concentration using the enzyme-linked immunosorbent assay. Change in systolic blood pressure measured in millimeters of mercury. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Calibrated digital blood pressure monitor after at least five minutes of seated rest; the mean of two measurements will be recorded. Change in diastolic blood pressure measured in millimeters of mercury. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Calibrated digital blood pressure monitor after at least five minutes of seated rest; the mean of two measurements will be recorded. 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: Calibrated digital blood pressure monitor after at least five minutes of seated rest. Change in serum alanine aminotransferase level. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of alanine aminotransferase activity using a standard enzymatic colorimetric assay and an automated biochemistry analyzer. Change in serum aspartate aminotransferase level. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of aspartate aminotransferase activity using a standard enzymatic colorimetric assay 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: Complete blood count testing 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 DezfulUniversity of Medical Sciences Azadegan Street, Dezful University of Medical Sciences, School of Medicine Dezful Khouzestan Iran (Islamic Republic of)