TCTR20130528001招募中2 期
Pentoxifylline and Metformin versus Placebo for The Treatment of Patients with Nonalcoholic steatohepatitis, A Randomized, Double-Blinded, Placebo- Controlled Clinical Trial.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 38
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
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. biopsy proven NASH performed within 2 year of entry
- •2. ALT > 1.5 times of ULN and repeated at least twice over 6 months
- •3. life style modification in the outpatient clinic for up to 3 months and persistent ALT elevation
- •4. Not taking metformin or PTX at least 3 month prior to entry
- •5. type 2 DM Patients included only if on oral hypoglycemic drug and with hemoglobin A1C <8%
排除标准
- •1. Alcohol intake > 20gm/day in men and 10 gm/day in women for 2 years
- •Other chronic liver diseases
- •2. Decompensated cirrhosis
- •3. Secondary steatohepatitis e.g. drug
- •(tamoxifen, methotrexate, amiodarone, valproate, glucocorticoid)
- •4. Taking medications that have shown benefits in previous NASH studies e.g. pioglitazone, Vitamin E, Folic acid, UDCA, Omega 3, NAC
- •Cr > 1.5mg/dl
- •5. A history of drug allergy to PTX or methylxanthines (caffeine, theophylline) and metformin
- •6. Risk of bleeding tendency
- •7. Pregnancy
- •8. Refuse Liver biopsy
研究者
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