CTRI/2019/06/019926招募中4 期
COMPARATIVE EVALUATION OF EFFICACY AND SAFETY OF METFORMIN AND GLIMEPIRIDE WITH CONCOMITANT ROSUVASTATIN IN PATIENTS OF NON ALCOHOLIC FATTY LIVER DISEASE WITH COEXISTENT TYPE 2 DIABETES MELLITUS
nil0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •o NAFLD diagnosed by suggestive imaging findings (ultrasound) with
- •abnormal aminotransferase levels. AST 50-150 U/L (1 to 3 times the
- •upper limit of normal).
- •o Concomitant with newly diagnosed T2DM.
- •o Subjects between age group 20 â?? 60 years of either sex
排除标准
- •1. Hypersensitivity to metformin, glimepiride and rosuvastatin.
- •2. Patients with age group < 20 years and > 60 years.
- •3. Patients with Type 1 Diabetes and Type 2 diabetes with end stage
- •complications and diabetic ketoacidosis.
- •4. Pregnancy and lactation.
- •5. Patients with hypotensive states, thyroid disorders, adrenal insufficiency,
- •heart failure, respiratory disorders tuberculosis, hepatobiliary disease,
- •chronic renal disease.
- •6. Patients with hepatitis B & C and significantly deranged enzymes (ALT >
- •3 times normal values)
- •7. Patients with ascites, inflammatory bowel disease, malignancies, G6PD
- •deficiency.
- •8. Patients on drugs causing hepatic steatosis.
- •9. Chronic drug or alcohol abuse (daily intake > 20g (2.5 units) in females
- •and 30g (3.5 units) in males
- •10. Patients with comorbidities like microvascular complications, recent ( <1
- •year) Myocardial infarction, acute coronary syndrome, stroke, osmotic
- •symptoms, history of ketosis, weight loss of >3 kg in preceding 3 months.
- •11. Patients on drugs causing fatty liver changes like â?? amiodarone,
- •methotrexate, tamoxifen, antiretroviral drugs, tetracyclines,
- •acetaminophen & corticosteroids.
- •12. Patients on drugs like cimetidine, gemfibrozil, cyclosporine, digoxin,
- •warfarin, beta blockers, calcium channel blockers, macrolide antibiotics,
- •azole antifungals, cholestyramine, diazoxide, oestrogens, hydantoin,
- •isoniazid, nicotinic acid, phenothiazines, rifampin, thiazide diuretics,
- •urinary alkalinizers, furosemide.
- •13. Patients with megaloblastic anaemia, myopathy
- •14. Any trauma, surgery.
- •15. Patients refusing to give informed consent.
研究者
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