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IRCT20140307016876N3 IRCT 2018-02-25 Shiraz University of Medical Sciences The effects of ginger on fatty liver in type 2 diabetic patients Study of the effect of ginger on biochemical markers and imaging of non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus. 2018-03-06 anticipated 70 Complete https://irct.ir/trial/29361 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Seventy diabetic patients with inclusion criteria who have fatty liver in ultrasound that graded based on the Saverymuttu Scoring System by a radiologist will enter the stydy. After justifying them to the study and obtaining written informed consent will be divided in two groups of 35 patients, A and B with use of random numbers, Blinding description: Medication is made by a personal centre that has no relation with the patients and the research team and from the beginning, it is classified into two groups A and B with a completely similar appearance. The patients are also fully aware of the way the program is performed, but they do not know whether they are receiving the main medicine or the placebo. And the researcher who is related to the patients, as well as physicians who perform paraclinical and therapeutic procedures of the patients are not aware of which group of patients are in the intervention, as well as the collector information and data and statistics consultant are not aware of the content of these two groups. 3 Condition 1: Non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus. Condition 2: Type 2 diabetes mellitus. Intervention 1: Capsule containing ginger powder (500 mg) three times daily, half an hour after meal for 3 months. Intervention 2: Capsule containing 500 mg of starch powder and ginger with a ratio of 1:10 three times daily, half an hour after meal for 3 months. Yes - There is a plan to make this available What will be shared: Primary outcome measures When: 3 months after publication To whom: People working in academic institutions Conditions: ----- Where to obtain: Email: shams@sums.ac.ir How to obtain: After evaluation of the request Comments:
public Parissa Sadat Ghoreishi
Traditional Medicine Department, Faculty of Medicine, Imam Hossein Square, Zand Ave.
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3234 5145 drghoreishi@yahoo.com Shiraz University of Medical Sciences scientific Mesbah Shams
Endocrine and Metabolism Research Center, Nemazee Hospital, Shiraz
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4316 shams@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) The patient with type 2 diabetes mellitus Fasting blood sugar between 80 and 130 and HbA1C is less than 7% Age range 25 to 65 years Body mass index (BMI) ranges from 22 to 35 kg / m 2 The serum alanine transaminase level (ALT) is more than one and a half times higher than normal (ie, in men more than 45 and in women more than or equal to 29 units per liter according to the latest definition of abnormal ALT in men and women) Having a high-fatty liver disease (moderate to high) in liver ultrasound Conscious informed consent of patients to participate in the study 25 years 65 years Both Pregnancy Liver failure (acute or chronic) Hepatitis such as autoimmune hepatitis, viral hepatitis B and C (active or inactive), Wilson's disease and ... Hypo and hyperthyroidism Renal failure (creatinin above 1.5 mg / dL) Diabetes-induced retinopathy Diabetic Nephropathy alcohol consumption Any malignancy (treated or not) Taking warfarin Taking contraceptives, ursodeoxycholic acid, glucocorticoids, statins, probiotics, vitamin E in the last three months History of allergy to ginger Addiction and drug abuse Heart disease History of allergy K76.0 E11 Fatty (change of) liver, not elsewhere classified Type 2 diabetes mellitus Treatment - Drugs Treatment - Drugs Capsule containing ginger powder (500 mg) three times daily, half an hour after meal for 3 months. Capsule containing 500 mg of starch powder and ginger with a ratio of 1:10 three times daily, half an hour after meal for 3 months. Liver aminotrransferase (ALT) Level. Timepoint: Before intervention and three months after the intervention. Method of measurement: Colorimetric method. Liver fibrosis. Timepoint: Before and three months after the intervention. Method of measurement: Fibrosan (ultrasound waves). Weight. Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Balance. Body Mass Index (BMI). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Formula: Weight (Kg)/(Height)(m)2. Abdominal circumference. Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Tape measure. Hip circumference. Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Tape measure. Insulin resistance index. Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Homeostasis model assessment (HOMA-IR). Glycosylated hemoglobin (HbA1C). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: HPLC. Fasting Blood Sugar (FBS). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Enzymatic method. Serum triglyceride (TG). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Enzymatic method. Serum Cholesterol (Chol). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Colorimetric method. Serum levels of aspartate aminotransferase (AST). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Colorimetric method. Serum level of gamma glutamyltransp peptidase (GGT). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Colorimetric method. Serum creatinine level. Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Colorimetric method. Tumor necrosis factor-alpha (TNF-α). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: ELISA (Enzyme Linked Immuno Sorbent Assay). High sensitive C-reactive protein (hsCRP). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: ELISA (Enzyme linked Immunosorbent assay). Shiraz University of Medical Sciences Approved 2017-11-13 Ethics Committee on Research in Shiraz Medical School Shiraz Medical School, Zand Ave., Imam Hossein Square Shiraz Fars Iran (Islamic Republic of)