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IRCT20110123005670N29 IRCT 2022-06-22 Tabriz University of Medical Sciences Evaluation of the effect of curcumin in patients after kidney transplantation The effect of curcumin supplementation on nutritional status, glucose and lipid pattern, blood pressure, inflammatory status, oxidative stress, infection, and early graft function in patients after kidney transplantation 2022-10-22 anticipated 40 Complete https://irct.ir/trial/63535 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After reaching the inclusion criteria, individuals will be randomly divided into two groups of intervention and placebo by blocking method. Blocking will be performed based on age (18-48, 60-48) and sex (male and female) and whereby the two groups will be matched in terms of age and gender. The four blocks will be created by STATA statistical software using ralloc command, which will be identified by the letters A, B, C, D. The assigned group is not known before the individual assignment, Blinding description: All capsules (curcumin and placebo) in the same shape and color are placed and labeled in the containers by a third person, and two codes are given to individuals, and the codes will be unknown to the researcher until the end of the study. 3 patients after kidney transplantation. Intervention 1: Intervention group: Intervention group: Curcumin capsules, one capsule containing 500 mg of curcumin (C3 complex, Sami Labs Ltd., Indi) daily with 5 mg of piperine (black pepper extract containing 95% piperine, Sami Labs Ltd., Indi) during this study. It lasts 12 weeks. Intervention 2: Control group: Placebo capsules, which are similar in shape and size to curcumin capsules and contain 505 mg of maltodextrin (C3 complex, Sami Labs Ltd., Indi), are given daily for 12 weeks. 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 There is no more information
public Dr. Ali Tarighat Esfanjani
Tabriz University of Medical Sciences, Faculty of nutrition., Golgasht ave., tabriz
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3335 7582 tarighata@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Ali Tarighat Esfanjani
Faculty of nutrition., Golgasht ave., tabriz
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3335 7582 tarighata@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Age range 18-60 years People receiving kidneys from a deceased donor Complete and informed consent to participate in the research project People who do not have other diseases that increase oxidative stress, such as inflammatory bowel disease, liver cirrhosis, tumors and cancer People who only had a kidney transplant Do not take curcumin, turmeric and omega-3 supplements, vitamin E and C supplements within one month before the start of the study Do not take antiepileptic drugs within a month before the start of the study 18 years 60 years Both People with cognitive disorders such as Alzheimer's Z94.0 Kidney transplant status Treatment - Other Placebo Intervention group: Intervention group: Curcumin capsules, one capsule containing 500 mg of curcumin (C3 complex, Sami Labs Ltd., Indi) daily with 5 mg of piperine (black pepper extract containing 95% piperine, Sami Labs Ltd., Indi) during this study. It lasts 12 weeks Control group: Placebo capsules, which are similar in shape and size to curcumin capsules and contain 505 mg of maltodextrin (C3 complex, Sami Labs Ltd., Indi), are given daily for 12 weeks. Blood sugar. Timepoint: At the beginning of the study and at the end of the study. Method of measurement: Biochemical testing. Lipid profile. Timepoint: At the beginning of the study and at the end of the study. Method of measurement: Biochemical testing. Blood pressure. Timepoint: At the beginning of the study and at the end of the study. Method of measurement: Biochemical testing. Glomerular filtration rate. Timepoint: At the beginning of the study and at the end of the study. Method of measurement: Biochemical testing. Delay graft function. Timepoint: From the beginning of the study to the end of the first week. Method of measurement: Need dialysis during the first week after transplantation. Slow graft function. Timepoint: From the beginning of the study to the end of the tenth day. Method of measurement: Serum creatinine greater than 2.5 mg/dL on day 10 after transplantation. Occurrence of acute graft rejection. Timepoint: From the beginning of the study to the end of the study. Method of measurement: Permanent return to dialysis, re-transplantation or death with an active transplant. Incidence of viral infections. Timepoint: During the study. Method of measurement: Diagnosis by the treating physician. Weight. Timepoint: Beginning and end of the study. Method of measurement: With minimal clothing and without shoes and using Seca scales with an accuracy of 0.1 kg. Height. Timepoint: Beginning and end of the study. Method of measurement: Shoeless by the meter mounted to the wall with an accuracy of 0.1 cm. Waist circumference. Timepoint: Beginning and end of the study. Method of measurement: In the middle of the area between the lowest rib and the highest part of the pelvis at the end of natural exhalation using an inelastic tape measure without pressure on the body surface. Length of hospital stay. Timepoint: during study. Method of measurement: Number of hospitalization days. Leukopenia. Timepoint: Beginning and end of the study. Method of measurement: By counting the WBC. Thrombocytopenia. Timepoint: Beginning and end of the study. Method of measurement: With platelet count less than 150,000 per microliter. Neutropenia. Timepoint: Beginning and end of the study. Method of measurement: With a neutrophil count of less than 1500 per microliter. Tabriz University of Medical Sciences Approved 2022-06-01 Ethics committee of Tabriz University of Medical Sciences golgasht Ave., Tabriz university of medical sciences Tabriz East Azarbaijan Iran (Islamic Republic of)