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IRCT20181022041407N2 IRCT 2023-01-28 Mashhad University of Medical Sciences Investigating the effect of Curcumin on prediabetic individuals Examining the effect of Curcumin on fasting blood sugar and insulin resistance index in prediabetic individuals 2023-02-20 anticipated 56 Complete https://irct.ir/trial/67748 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization was done using the block sizes of 4 and 6 with randomization websites such as sealedenvelope.com. After randomization, the type of treatment is written with odds and even numbers (or A/B codes) in separate papers and placed in an opaque envelope or the paper will wrap so that no one can see inside the paper (random concealment). After obtaining informed consent from the participants, one paper will be taken in order and according to the noted code, the child is place in one of the intervention or placebo groups, Blinding description: As mentioned before, after randomization, the patients place in two groups of A/B (or odds/even codes) and received the products similar in shape, color and size (blinding of participants). The physician who will give the products to participants, 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). 2-3 Prediabetes. Intervention 1: Intervention group: Curcumin tablet daily (contains 500 mg Curcumin and 5 mg Piperine). Intervention 2: Control group: placebo (similar to intervention in shape, size and color). 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 project. 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 Zahra Mazloum khorasani
Between Moallem 8th and 10, Moallem Blvd.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3601 7449 mazloumz@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Individuals aged 18-70 years Prediabetes status Satisfaction for participation in research project 18 years 70 years Both Using anti diabetic drugs or other drugs which affect on blood sugar such as Thiazide, Glucocorticoids, Anti-psychotics Systemic disorders such as hepatic or renal failure Oral intolerance Using anti-coagulant drugs R73.0 Abnormal glucose tolerance test Treatment - Drugs Placebo Intervention group: Curcumin tablet daily (contains 500 mg Curcumin and 5 mg Piperine) Control group: placebo (similar to intervention in shape, size and color) FBS (Fasting Blood Sugar). Timepoint: Baseline and after 3 months. Method of measurement: Blood sample. HOMA-IR (Homeostatic Model Assessment for Insulin Resistance). Timepoint: Baseline and after 3 months. Method of measurement: Using formula: (Glucose * insulin)/405. CRP, HbA1C, Insulin. Timepoint: Baseline and after 3 months. Method of measurement: Blood sample. Mashhad University of Medical Sciences Approved 2022-12-20 Research Ethics Committees of School of Medicine, Mashhad University of Medical Sciences Faculty of Medicine, University Campus, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)