| Trial ID: | L0508 |
| Source ID: | IRCT20140307016876N3
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| Associated Drug: |
Ginger
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| Title: |
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.
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| Acronym: |
--
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| Status: |
Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Condition 1: Non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus. Condition 2: Type 2 diabetes mellitus. <br>Fatty (change of) liver, not elsewhere classified <br>Type 2 diabetes mellitus
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| Interventions: |
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
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| Outcome Measures: |
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-a). 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).
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| Sponsor/Collaborators: |
Shiraz University of Medical Sciences
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| Gender: |
All
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| Age: |
25 years65 years
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| Phases: |
Phase 3
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| Enrollment: |
70
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| Study Type: |
interventional
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| Study Designs: |
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 Saverymu
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| Start Date: |
25/02/2018
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
26 March 2018
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| Locations: |
Iran (Islamic Republic of)
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| URL: |
http://en.irct.ir/trial/29361
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