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IRCT20220608055102N1 IRCT 2022-06-13 Esfahan University of Medical Sciences The effect of hot-tempered diet on the signs and symptoms and levels of thyroid hormones The effects of hot-tempered diet on signs, symptoms and serum thyroid hormones level in Symptomatic but euthyroid hypothyroid patients treated with levothyroxine. 2022-07-01 anticipated 49 Complete https://irct.ir/trial/64035 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Blinding description: In this study, all patients before and after receiving the diet were examined for the Zulewski score and serum levels of TSH and Total T3 were measured; Since the scoring is filled out by the clinic doctor, the examinator is unaware of the study and the reason behind the examination. N/A Hypothyroidism. Each person is given dietary measures based on traditional Iranian medicine, which are classified as hot and cold temperament. These recommendations include eliminating cold-tempered foods and consuming hot-tempered foods. Patients are asked to complete the food frequency form twice a week, which will be reviewed at the next visit. Any patient who follows less than 70% of the recommendations Has been removed from the study.Educating each patient during the first visit is to explain the reason and method of study, a list of hot and cold foods, giving a sufficient number of food frequency forms and the contact number of the support doctor for emergencies.. Yes - There is a plan to make this available What will be shared: Deidentified individual participant data collected for the primary and secondary outcome measures will be shared if necessary. When: Starting 6 months after publication. To whom: The data will be available for physicians working in academic institutions and also clinicians working in the field of internal medicine. Conditions: The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of internal medicine. Where to obtain: Applicants can contact Dr. Mohammad Shirzadi by email. Email address: omid.shirzadi@gmail.com How to obtain: Applicants should explain in detail about their project and how the data/documents of this study will be used in their project. Then, the data/documents files will be sent by email to applicants on request. This process may takes 10-12 working days. Comments:
public Mohammad Shirzadi
Alzahra hospital, Shohada e Soffe Ave.
Isfahan Iran (Islamic Republic of) 81746 +98 31 3620 1274 omid.shirzadi@gmail.com Esfahan University of Medical Sciences scientific Mohammad Shirzadi
Alzahra hospital, Shohada e Soffe Ave.
Isfahan Iran (Islamic Republic of) 81746 +98 31 3620 1274 omid.shirzadi@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Hypothyroid patients have been treated with levothyroxine. Patients who have had normal TSH(5-5/0) in the last 3 months. Zulewski score Zulewski score > 3. 18 years 60 years Both Pregnancy. Hypothyroidism caused by surgery or radioactive iodine. Chronic diseases such as diabetes mellitus. Dose changing of levothyroxine during the study. Taking interfering drugs with thyroid tests. Diseases of the hypothalamus and pituitary gland. E03.9 Hypothyroidism, unspecified Rehabilitation Each person is given dietary measures based on traditional Iranian medicine, which are classified as hot and cold temperament. These recommendations include eliminating cold-tempered foods and consuming hot-tempered foods. Patients are asked to complete the food frequency form twice a week, which will be reviewed at the next visit. Any patient who follows less than 70% of the recommendations Has been removed from the study.Educating each patient during the first visit is to explain the reason and method of study, a list of hot and cold foods, giving a sufficient number of food frequency forms and the contact number of the support doctor for emergencies. Zulewski score. Timepoint: At the beginning and 6 weeks later. Method of measurement: Zulewski questionnaire. Thyroid stimulating hormone serum level. Timepoint: At the beginning and 6 weeks later. Method of measurement: Laboratory. Triiodothyronine serum level. Timepoint: At the beginning and 6 weeks later. Method of measurement: Laboratory. Alanine transaminase serum level. Timepoint: At the beginning and 6 weeks later. Method of measurement: Laboratory. Creatinine serum level. Timepoint: At the beginning and 6 weeks later. Method of measurement: Laboratory. Esfahan University of Medical Sciences Approved 2020-11-29 Ethics committee of Isfahan University of Medical Sciences Isfahan, Hezar Jerib St., Isfahan University of Medical Sciences, Building No. 3, School of Medicine, Ground Floor, Department of Medical Ethics Isfahan Isfehan Iran (Islamic Republic of)