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IRCT20210101049909N1 IRCT 2021-06-18 Mashhad University of Medical Sciences The effect of thyrophyte herbal composition on the weight of patients with primary hypothyroidism Evaluation the effect of thyrophyte herbal composition on the weight of patients with primary hypothyroidism 2021-07-06 anticipated 80 Complete https://irct.ir/trial/56663 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into Intervention and control groups in blocked randomization model by using the random numbers table and randomization.com site. The method of allocation concealment is sealed envelope , Blinding description: Participants, researcher and analyzer are unaware of the individuals assigned to the intervention and control group. Only the sample assignor to the groups is aware of the control and intervention group. 2 Hypothyroidy. Intervention 1: Intervention group: They receive levothyroxine and herbal composition (nigella sativa, trachyspermum ammi, citrus aurantifolia) at a dose of 4.5 g daily in 6 capsules of 750 mg for 8 weeks. Intervention 2: Control group: They receive Levothyroxine and placebo (Avisel) capsule for 8 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 more information
public Najme Javidi
School of Traditional and Compelementary Medicine, Ferdosi University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3884 8931 javidin9711@mums.ac.ir Mashhad University of Medical Sciences scientific Mahdi Yousefi
School of Traditional and Compelementary Medicine, Ferdosi University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3884 8931 Yousefim@mum.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age: 20 to 65 years Patients known to have primary hypothyroidism by an endocrinologist Hypothyroid patients with overweight or obesity whose weight has not been controlled with levothyroxine 20 years 65 years Both Uncontrolled systemic diseases Any diet for weight loss during the study and 3 months before arrival Take a vitamin supplement at least three months before or during the study Patient dissatisfaction with continued cooperation Pregnancy Lactation (E00-E90) Ectopic endocrine tissue or hyperfunction and hypofunction of endocrine glands associated with neoplasms and other conditions classified elsewhere Treatment - Drugs Placebo Intervention group: They receive levothyroxine and herbal composition (nigella sativa, trachyspermum ammi, citrus aurantifolia) at a dose of 4.5 g daily in 6 capsules of 750 mg for 8 weeks. Control group: They receive Levothyroxine and placebo (Avisel) capsule for 8 weeks. Weight. Timepoint: Before and after intervention. Method of measurement: To measure weight, calculate the ratio of weight in kilograms to height squared in meters (body mass index) and calculate the ratio of waist to hip in centimeters (WHR) using weight and tape meters. Lipid profile. Timepoint: Before and after intervention. Method of measurement: By blood test in mg/dl. Fasting blood sugar. Timepoint: Before and after intervention. Method of measurement: By blood test in mg/dl. Thyroid hormone (TSH, FT4, T3). Timepoint: Before and after intervention. Method of measurement: By blood test in ng/dl. Depression score on Beck Depression questionnaire. Timepoint: Before and after intervention. Method of measurement: Beck Depression questionnaire. Quality of Life score on WHO Quality of Life Questionnaire. Timepoint: Before and after intervention. Method of measurement: WHO Quality of Life Questionnaire. Mashhad University of Medical Sciences Approved 2021-05-08 The Ethics Committee of Mashhad University of Medical Sciences Mashhad Univercity Of Medical Sciences, University StreetThe Ethics Committee of Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)