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IRCT20190902044668N1 IRCT 2020-08-10 Shiraz University of Medical Sciences effects of curcumin on beta-thalassemia intermedia Evaluation of the effects of curcumin on GDF15 gene expression and iron status in patients with beta-thalassemia intermedia 2020-04-19 anticipated 30 Complete https://irct.ir/trial/50084 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: no, Randomization description: 15 cards with the intervention group code label and 15 cards with the placebo group code label were placed inside the sealed envelopes and each patient was asked to choose randomly one of these envelopes, Blinding description: The drugs were distributed to patients in unlabeled sealed paper bags. The main drug and the placebo drug are both taken from the pharmaceutical company, which are similar in shape, size, and color. The difference between the main drug and the placebo was not clear to the participants, The project manager will know the arrangement of the main drug and placebo. 2-3 Intermediate beta-thalassemia. Intervention 1: Intervention group: Curcumin; Each dose contains 450 mg of turmeric rhizome powder and 50 mg of turmeric extract, which is standardized based on 5.47 mg of curcumin. three months; Three doses per day orally; Dineh Pharmaceutical Company, Iran. Intervention 2: Control group: Placebo; Each dose contains 500 mg of starch or flour. three months; Three doses per orally; Dineh Iran Pharmaceutical Company. 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 I haven't decided yet.
public Gholamhossein Tamaddon
Meshkin Fam St. Paramedical School
Shiraz Iran (Islamic Republic of) 71439-14693 +98 71 3227 0240 tamaddon.g@gmail.com Shiraz University of Medical Sciences scientific mohammadreza saeidnia
Meshkin Fam St. Paramedical School
Shiraz Iran (Islamic Republic of) 71439-14693 +98 71 3227 0240 m.rezasaeednia@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) gender male Lack of sensitivity to turmeric compounds The beta-thalassemia intermedia is approved by the doctor. 18 years 35 years Male Cardiovascular disease Diabetes Gallbladder removal D56.1 Beta thalassemia Treatment - Drugs Placebo Intervention group: Curcumin; Each dose contains 450 mg of turmeric rhizome powder and 50 mg of turmeric extract, which is standardized based on 5.47 mg of curcumin. three months; Three doses per day orally; Dineh Pharmaceutical Company, Iran. Control group: Placebo; Each dose contains 500 mg of starch or flour. three months; Three doses per orally; Dineh Iran Pharmaceutical Company. Serum iron. Timepoint: At the beginning of the study (before the intervention) and three months after the start of curcumin intake. Method of measurement: Atomic absorption spectrometry، ELISA kit. Serum ferritin concentrations. Timepoint: At the beginning of the study (before the intervention) and three months after the start of curcumin intake. Method of measurement: ELISA. C-reactive protein (CRP). Timepoint: At the beginning of the study (before the intervention) and three months after the start of curcumin intake. Method of measurement: ELISA. Shiraz University of Medical Sciences Approved 2020-04-19 Ethics Committee of Shiraz University of Medical Sciences Meshkin Fam St. Paramedical School Shiraz Fars Iran (Islamic Republic of)