A Phase III, multicentre, randomized, double-blind, placebo-controlled, interventional study on efficacy and safety of Standardized fraction of Picrorhiza kurroa Royal Ex Benth (Picroliv®) for 24 weeks in the Management of Non-Alcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 6
- 主要终点
- Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
研究概览
简要总结
Nonalcoholic fatty liver disease (NAFLD) is an emerging health problem worldwide, affecting between 25% and 30% of the general population. NAFLD refers to a spectrum ranging from noninflammatory isolated steatosis to nonalcoholic steatohepatitis (NASH), which is characterized by steatosis, necroinflammatory changes, and varying degrees of liver fibrosis. Picrorhiza kurroa is a well-known herb in the Ayurvedic system of medicine and has traditionally been used to treat disorders of the liver. It is antioxidant and has anti-inflammatory activities. The use of Picroliv which is standardized as per phytopharmaceutical guidelines of Govt. of India for the treatment of NAFLD will be safe and effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •3.Patients showing presence of hepatic fat fraction as defined by ≥ 10% on MRI-PDFF at screening 4.Liver enzymes normal or above the ULN (upper limit of Normal Range) but less than 3 times 5.Adults who are diagnosed with uncomplicated NAFLD (fibrosis score up to F2) by transient elastography.
- •6.Hemoglobin ≥10 g/dL, a platelet count ≥ 100 x 109/L, and a white blood cell count ≥ 3.0 x 109/L 7.HbA1c < 7%.
排除标准
- •1.Significant alcohol consumption (> 210 g/week in males and > 70 g/week in females) 2.eGFR < 60 mL/min / 1.73m2 or patients on dialysis 3.Hepato-biliary disorders: Cirrhosis, biliary obstruction, chronic cholecystitis, cholelithiasis, active or chronic active Hepatitis B or hepatitis C, autoimmune liver diseases 4.Any disorder or clinically significant finding that may potentially impact the outcome measures as per the discretion of the study investigator.
- •5.Pregnant and lactating women.
- •6.Not willing to provide written informed consent 7.Females unwilling to use any form of contraception during the trial.
结局指标
主要结局
Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
时间窗: Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
次要结局
- Change from baseline to Week 24 in hepatic stiffness by transient elastography(0 and 24 weeks)
- Change from baseline to week 24 in clinical laboratory variables of Liver function(0, 12, 24 weeks)
- Change from baseline to week 24 in clinical laboratory variables of lipid profile(0,12,24 weeks)
- Change from baseline to week 24 in Liver indices / scores – NAFLD fibrosis score, FIB4 index, ELF score, Fatty Liver Index, APRI..(0,12,24 weeks)
- Change in baseline clinical signs and symptoms at every follow up: Low appetite, distaste, heaviness of the abdomen, constipation, inactivity stiffness, fatigue, pain in right upper abdomen and any other(0,2,4, 8, 12, 18, 24 weeks)