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IRCT20190415043279N5 IRCT 2020-07-11 Sanandaj University of Medical Sciences Assessment of the effect of Portulaca oleracea on hyperthyroidism Assessment of the effect of hydroalcoholic extract of Portulaca oleracea on thyroid hormones in hyperthyroidism 2020-07-22 anticipated 50 Complete https://irct.ir/trial/48812 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 Portulaca oleracea) and the other will receive placebo. Individuals are the randomization unit, making a random sequence is by using statistical software (WinPepi11.0). Allocation concealment is by assigning unique codes, 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 Hyperthyroidism. Intervention 1: Intervention group: Capsule containing hydroalcoholic extract of Portulaca oleracea plant at dose of 400 mg three times a day for two consecutive months. These oral capsules of hydroalcoholic extract of Portulaca oleracea plant are prepared by a reputable pharmacist. Intervention 2: Control group: Placebo in capsules at dose of 400 mg three times a day for two 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) Recently diagnosed hyperthyroid patients 18 years 70 years Both Pregnancy Children Cardiovascular disease Ophthalmopathy Thyroiditis E05.9 Thyrotoxicosis, unspecified Placebo Placebo Intervention group: Capsule containing hydroalcoholic extract of Portulaca oleracea plant at dose of 400 mg three times a day for two consecutive months. These oral capsules of hydroalcoholic extract of Portulaca oleracea plant are prepared by a reputable pharmacist. Control group: Placebo in capsules at dose of 400 mg three times a day for two 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 two months later. Method of measurement: ELISA. Serum T4 levels. Timepoint: Measurement of T4 levels before the intervention and two months later. Method of measurement: ELISA. Serum T3 levels. Timepoint: Measurement of T3 levels before the intervention and two months later. Method of measurement: ELISA. Body Mass Index. Timepoint: Measurement of BMI before the intervention and two months later. Method of measurement: According to the BMI formula (BMI = (weight in kilograms) divided by (Height in meters squared)). Sanandaj University of Medical Sciences Approved 2019-07-10 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)