NCT01384578撤回3 期
A Randomized Controlled Project to Study the Efficacy of Combined Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis (NAS score).
研究概览
简要总结
120 patients of biopsy proven NASH will be randomized into two groups. Cases group will receive combination of pentoxiphylline and Vitamin E, and control group will receive only Vitamin E.
详细描述
The investigators plan to randomise 120 patients of biopsy proven NASH into cases and control groups.
Baseline investigations:
Clinical characteristics
- Age
- Gender
- Anthropometry (BMI, waist circumference, waist- hip ratio, triceps skin fold thickness, mid arm circumference)
- Alcohol intake should be nil
Laboratory characteristics
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years
- •Persistently abnormal ALT >1.2 times upper limit of normal
- •Histological evidence of NASH/cirrhosis on liver biopsy. ( The minimal criteria for diagnosis of NASH included the presence of lobular inflammation and either ballooning of cells or perisinusoidal or pericellular fibrosis in Zone 3 of the hepatic acinus)
排除标准
- •A known case of Type 2 diabetes mellitus on treatment
- •Alcohol intake of more than 40gm / week
- •If they had evidence of cirrhosis with significant portal hypertension
- •Ongoing total parenteral nutrition/ jejunal-ileal bypass
- •Other known liver disease (Hepatitis A to E, autoimmune liver disease, Wilson's disease, alpha 1 antitrypsin deficiency and hemochromatosis)
- •Medication like estrogens, amiodarone, MTx, tamoxifen, ATT
- •Pregnancy or lactation
- •Hypersensitivity to methylxanthines (e.g., caffeine, theophylline, theobromine )
- •Recent retinal/cerebral hemorrhage
- •Acute myocardial infarction or severe cardiac arrhythmias
- •Impaired renal function
- •Hypothyroidism
研究组 & 干预措施
pentoxiphylline and Vitamin E
Experimental
干预措施: pentoxiphylline and Vitamin E (Drug)
Vitamin E
Active Comparator
干预措施: Vitamin E (Drug)
结局指标
主要结局
histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis (NAS score).
时间窗: 3 Months
次要结局
- Response in form of anthropometry , HOMA-IR, fasting lipid profiles, biochemical response in form of normalization of ALT and AST levels and reduction in uric(3 Months)
研究者
研究点 (1)
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