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IRCT20181022041407N3 IRCT 2023-06-17 Mashhad University of Medical Sciences The effect of curcumin on type 1 diabetes The effect of curcumin on glycemic control in children with type 1 diabetes 2023-06-22 anticipated 64 Complete https://irct.ir/trial/67388 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be done using the block sizes of 4 and 6 with randomization website (www.sealedenvelope.com). After randomization, the type of treatment will be written with A/B codes on separate papers and placed in an opaque envelope or the paper will wrap so that no one can see inside the paper (allocation concealment). After obtaining informed consent from the children and their parents, one paper will be taken in order and according to the noted code, the child will be placed in one of the intervention or placebo groups, Blinding description: As mentioned before, after randomization, the patients will be placed in two groups of A/B and will be received the products similar in shape, color and size (blinding of participants). The physician will received the boxes of the products with randomized codes (so the physician is blind too). The information of the patients and theirs treatment groups will be written with randomized codes (A/B) (the blinding of the assessor). Data will be entered to the SPSS software with codes (the blinding of the analyzer). 2 Insulin-dependent diabetes mellitus. Intervention 1: Intervention group: Curcumin tablet daily (contains 500 mg Curcumin and 5 mg Piperine) made by Sami-Sabinsa Group Limited, for 90 days. Intervention 2: Control group: placebo (microcrystalline cellulose) made by Sami-Sabinsa Group Limited, for 90 days. 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 This project conducts between medical and pharmacy faculty and it is an interdisciplinary filed. All of the collaborators must satisfied with this item. We will decide about this part in future.
public Maryam Emadzadeh
Clinical Research Development Unit, Ghaem Hospital, Ahmadabad Blvd.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3841 7403 maryamemadzadeh@yahoo.com Mashhad University of Medical Sciences scientific Somayyeh Hashemian
between 1st and 3rd Besat, Besat Blvd.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3841 0000 hashemians951@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Children aged 7-18 years Having type 1 diabetes Satisfaction for participation in research project 7 years 18 years Both Patients with systemic diseases like renal or hepatic failure Oral intolerance of product Not satisfied with continuation of the study E10 Type 1 diabetes mellitus Treatment - Drugs Placebo Intervention group: Curcumin tablet daily (contains 500 mg Curcumin and 5 mg Piperine) made by Sami-Sabinsa Group Limited, for 90 days Control group: placebo (microcrystalline cellulose) made by Sami-Sabinsa Group Limited, for 90 days Fasting Blood Sugar (FBS). Timepoint: baseline and monthly for 3 months. Method of measurement: blood sample. HbA1C. Timepoint: baseline, after 3 months. Method of measurement: blood sample. Microalbuminuria. Timepoint: baseline and after 3 months. Method of measurement: urine analysis. Mashhad University of Medical Sciences Approved 2023-05-20 Research Ethics Committees of Mashhad University of Medical Sciences Ghoreshi Building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)