Efficacy and Safety of Saroglitazar and Vitamin E in NAFLD Related Compensated Advanced Chronic Liver Disease.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- PGIMER
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary Outcomes:
研究概览
简要总结
NAFLD emerging as the most common liver disease in the modern era. Though obesity is a prominent cause of NAFLD, it is also observed in patients in prediabetic and patient with metabolic risk factors. Interventions resulting in weight loss has a prominent role in treatment of NAFLD. Saroglitazar is a DGCI approved drug for the treatment of NAFLD by pharmacotherapy. Saroglitazar may have beneficial role in NAFLD with cACLD. No studies have analyzed the role of pharmacotherapy in Pre-diabetic NAFLD this study will also give insight about various MRI parameters for detection of significant fibrosis in NAFLD. We will conduct this study to look for the safety and efficacy of Saroglitazar in the treatment of NAFLD patients with cACLD
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Day(s) 至 75.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Age18-75years 2.Patients with NAFLD: Defined by the presence of hepatic steatosis on ultrasound or using CAP parameters (of FibroScan) in absence significant consumption of alcohol (<20g/day irrespective of gender) after ruling out other etiologies for hepatic steatosis or elevated transaminases including but not limited to chronic viral hepatitis, autoimmune Hepatitis, hemochromatosis, Wilson disease, celiac disease, Drug induced liver injury (DILI), etc.
- •3.Patients with LSM> 10kPa 4.Consent to participate in study.
排除标准
- •1.Patients <18years of age 2.Patients with Hepatic decompensation 3.Patients with HCC or any other malignancy 4.Patients with concomitant other aetiologies for hepatic steatosis/fibrosis or elevated transaminases 5.Patients already on Vitamin E or pioglitazone 6.Pregnancy/Lactation and those non pregnant female patients recruited in the study who will conceive during the study period will be excluded from the study.
- •7.Patients who are too sick to conduct the protocol.
- •8.Those who do not consent to participate in the study.
结局指标
主要结局
Primary Outcomes:
时间窗: Primary Outcomes: | Improvement in the hepatic fibrosis in patients with NAFLD related compensated advanced chronic liver disease at the end of 6 months.
Improvement in the hepatic fibrosis in patients with NAFLD related compensated advanced chronic liver disease at the end of 6 months.
时间窗: Primary Outcomes: | Improvement in the hepatic fibrosis in patients with NAFLD related compensated advanced chronic liver disease at the end of 6 months.
次要结局
- Improvement in Hepatic fat fraction(Improvement in MRE)