The effect of oral zingiber officinale supplement in hemodialysis patients with diabetes

Phase 3

Recruiting

Conditions: Diabetic hemodialysis.
Type 2 diabetes mellitus with diabetic chronic kidney disease
E11.22

Registration Number: IRCT20191109045382N2

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 44

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.