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IRCT20191109045382N2 IRCT 2020-07-06 Tabriz University of Medical Sciences The effect of oral zingiber officinale supplement in hemodialysis patients with diabetes Comparison of the effect of oral zingiber officinale supplement and placebo on pre-oxidant-antioxidant balance and glycemic control in diabetic hemodialysis patients: A double blind randomized clinical trial 2020-02-09 anticipated 44 Complete https://irct.ir/trial/48467 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible individuals will be randomly assigned to one of the intervention or control groups, which will be randomly assigned based on the blocks created by the RAS software, Blinding description: In the present study, participants and researchers during the study did not know whether each individual would be in the intervention or control group. For blinding, ginger and placebo capsules will be similar in appearance, packaging and labeling. The capsules are prepared by the researcher with a capsule filling device. For this double blind study, at the start of the study, a set of bottles containing capsule is encoded A and B, by a person other than the researcher so that the researcher is not aware of the type of capsules received by each group. 3 Diabetic hemodialysis. Intervention 1: Intervention group: Patients in this group will take 4 ginger capsules 500 mg daily (prepared by the researcher or capsule filling machine) for 8 weeks. Intervention 2: Control group: In this group, patients take 4 corn starch capsules daily, which are prepared in the same shape and size as the drug capsules and will be consumed for 8 weeks. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared. When: Accessibility to data is possible 8 months after publication. To whom: The data will only be available for people working in academic institutions. Conditions: The data of the present study will only be accessible by other researchers, for conducting Meta analysis. Where to obtain: Dr. Zohreh Ghoreyshi, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences Email: ghoreyshiz@tbzmed.ac.ir phone number: 0098 912 739 0799 How to obtain: The applicator can send a request to the person responsible for the study by email and within 10 days the document will be sent to the requesting person. Comments:
public Helya Rostamkhani
Golgasht street, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3340 8619 helyarostamkhani@gmail.com Tabriz University of Medical Sciences scientific Dr. Zohreh Ghoreyshi
Faculty of Nutrition and Food Sciences, Golghast street, Attar Neishabouri street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3336 2117 ghoreyshiz@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Diabetic patients undergoing hemodialysis who have been on dialysis for at least 3 months Two or three dialysis sessions a week The duration of each session dialysis is 4 hours Patients who desire to enter the study Patients over 18 years of age 18 years no limit Both History of acute gastrointestinal disease History of Thyroid disorders History of gallstones Consumption of fish oil supplement Consumption steroid and non-steroidal anti-inflammatory drugs Consumption of Levothyroxine Consumption of Warfarin Consumption of antioxidant supplements History of ginger allergy Smoking E11.22 Type 2 diabetes mellitus with diabetic chronic kidney disease Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group will take 4 ginger capsules 500 mg daily (prepared by the researcher or capsule filling machine) for 8 weeks. Control group: In this group, patients take 4 corn starch capsules daily, which are prepared in the same shape and size as the drug capsules and will be consumed for 8 weeks. Prooxidant-antioxidant balance (PAB). Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Measurement by biochemical method and by ELISA kit. Level of fasting blood sugar (FBS). Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Measurement of fasting blood sugar (FBS) by enzymatic method. Level of insulin. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Measurement of insulin by enzymatic method. HOMA-IR scores. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Measurement of HOMA-IR score using formula. Serum urea levels. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Measurement of serum urea level by enzymatic method. Serum creatinine level. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Measurement of serum creatinine level by enzymatic method. Tabriz University of Medical Sciences Approved 2020-02-04 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)