Multi-Center, Randomized, Control, Phase IV Trial to Compare the Efficacy & Safety of Ursoplus® Capsules (UDCA 250mg & Silymarin 140mg) Versus UDCA Alone Versus Placebo Among Compensated Chronic Liver Diseased Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 297
- 试验地点
- 1
- 主要终点
- Change in Direct Serum Bilirubin
研究概览
简要总结
This study aims to compare the efficacy & safety of Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) versus UDCA alone versus Placebo among Compensated Chronic Liver Diseased Patients
详细描述
Research Question:
Compare the efficacy & safety of Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) versus UDCA alone versus Placebo among Compensated chronic liver diseased patients
Primary Objective:
To assess the efficacy of Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) versus UDCA 250mg alone and versus Placebo in the reduction of total serum bilirubin, Direct serum bilirubin and elevated liver Enzymes from baseline to End of Treatment (EOT)
Secondary Objectives:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged ≥ 18
- •Subjects with Compensated Chronic Liver Disease, defined as child 5-
- •Patients with mild disturbance of liver biochemical profile (elevated Total Serum Bilirubin ≤ 3 mg/dl, or elevated Direct Serum Bilirubin ≤ 2 mg/dl, or elevated one or more of liver enzymes, up to 3 times of the normal level (Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) & Gamma Glutamyl Transpeptidase (GGT)).
- •Non-diabetic subjects and subjects with Controlled DM-type 1 and 2 patients, HbA1C up to 7.5%
- •Non-pregnant or lactating female patients
- •Subjects who are willing to sign Informed Consent Form (ICF) and ready to comply with the protocol for the duration of the study
排除标准
- •Subjects with a history of hypersensitivity to any of the ingredients of the medications being studied
- •Subjects with positive PCR/or antibodies to Hepatitis C in the past 6 months
- •Subjects with positive hepatitis B surface antigen (HBsAg)
- •Subjects with elevated liver enzymes more than 3 times of the normal level Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) & Gamma Glutamyl Transpeptidase (GGT).
- •Subjects with Primary Biliary Cirrhosis (PBC) and Primary Sclerosing Cholangitis (PSC).
- •Subjects with Child Pugh Score more than
- •Subjects with history of bleeding varices.
- •Subjects having uncontrolled Diabetes (HbA1cmore than 7.5 %)
- •Subjects with any medical condition requiring the usage of medication that may interfere with the absorption, distribution, metabolism or excretion of the study drug such as:
- •Bile acid sequestering agents such as cholestyramine and colestipol.
- •Antacids containing aluminum hydroxide.
- •Drugs affecting lipid metabolism such as estrogens, oral and hormonal contraceptives, and clofibrate (and perhaps other lipid-lowering drugs)
- •Subjects who are receiving other liver support drugs (including drugs of the study), 1 month before study initiation.
- •Subjects with auto immune liver disease taking corticosteroid or immune suppressant
- •Pregnant or breast-feeding women
- •Use of oral contraceptives in child bearing ladies
研究组 & 干预措施
Ursoplus® capsules (UDCA 250mg & Silymarin 140mg)
Ursoplus® capsules: UDCA 250mg & Silymarin 140mg
2 Capsules every 12 hours
干预措施: Ursoplus (Drug)
UDCA 250mg
UDCA capsules: UDCA 250mg
2 Capsules every 12 hours
干预措施: UDCA 250mg (Drug)
Placebo
Placebo alone
2 Capsules every 12 hours
干预措施: Placebo (Other)
结局指标
主要结局
Change in Direct Serum Bilirubin
时间窗: Up to 6 months
Change in mean Direct Serum Bilirubin from baseline (visit 1) to End of study between the 3 treatment groups
Change in Total serum bilirubin
时间窗: Up to 6 months
Change in mean Total serum bilirubin from baseline (visit 1) to End of study between the 3 treatment groups
Change in Elevated Liver Enzymes
时间窗: Up to 6 months
Change in mean AST \& ALT from baseline (visit 1) to End of study between the 3 treatment groups
次要结局
- Improved degree of Steatosis(Up to 6 months)
- Improved quality of life(Up to 6 months)
- Incidence of adverse events (AEs)(Up to 6 months)