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IRCT20190415043279N3 IRCT 2020-05-24 Sanandaj University of Medical Sciences Evaluation of effect of trifolium plant on hypothyroidism Evaluation of effect of hydroalcoholic extract of trifolium plant in patients with subclinical hypothyroidism 2020-01-21 anticipated 40 Complete https://irct.ir/trial/47978 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using block randomization method with a block size of 4. Sampling method at this study will be according to random allocation. Participants will enter the study according to inclusion criteria, and then will be divided into two groups according to randomization table. One group will receive (Capsule containing hydroalcoholic extract of trifolium plant) and the other will receive placebo. The participants and administrator do not have any information about content of capsules (double blinded study). The list of randomization was computer-generated. supplements and placebo capsules were placed in completely identical packages and were coded by someone who was unaware of the nature of the study in numbered bottles based on the list. And another person who was unaware of the contents of the pack provided them to the patients, Blinding description: All supplements and placebo capsules were identical with respect to appearance and only differed in coding of the capsules. The treatment code of the intervention supplements was blinded for subjects, investigators and staff involved in the conduct of the study. 3 Subclinical hypothyroidism. Intervention 1: Intervention group: Capsule containing hydroalcoholic extract of trifolium plant at a dose of 500 mg per day for three consecutive months. These oral capsules of trifolium plant are prepared by a reputable pharmacist. Intervention 2: Control group: Placebo in capsules at a dose of 500 mg per day for three consecutive months These placebo oral capsules contain starch and are prepared by a reputable pharmacist. 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 No more information
public Shahnaz Ghafouri
Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
Sanandaj Iran (Islamic Republic of) 6617713466 +98 87 3366 4645 drghafoorish76@gmail.com Sanandaj University of Medical Sciences scientific Shahnaz Ghafouri
Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran.
Sanandaj Iran (Islamic Republic of) 6617713466 +98 87 3366 4645 drghafoorish76@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Patients with lately diagnosed subclinical hypothyroidism 18 years 70 years Both Thyroiditis Pregnancy Cardiovascular disease Thyroid cancer Recent surgery Blood disorders children Breastfeeding chronic Diseases Dissatisfaction patients to participate in the study E02 Subclinical iodine-deficiency hypothyroidism Placebo Placebo Intervention group: Capsule containing hydroalcoholic extract of trifolium plant at a dose of 500 mg per day for three consecutive months. These oral capsules of trifolium plant are prepared by a reputable pharmacist. Control group: Placebo in capsules at a dose of 500 mg per day for three consecutive months These placebo oral capsules contain starch and are prepared by a reputable pharmacist. Serum TSH levels. Timepoint: Measurement of TSH levels before the intervention and three months later. Method of measurement: Serum level evaluation. Serum T4 levels. Timepoint: Measurement of T4 levels before the intervention and three months later. Method of measurement: Serum level evaluation. Serum T3 levels. Timepoint: Measurement of T3 levels before the intervention and three months later. Method of measurement: Serum level evaluation. Sanandaj University of Medical Sciences Approved 2019-03-16 Ethics committee of Kurdistan University of Medical Sciences Vice Chancellor for research of Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran. Sanandaj Kurdistan Iran (Islamic Republic of)