NCT02006498已完成2 期
A Randomised, Double-blind, Placebo-controlled, Phase II, Single-centre Study to Assess the Safety and Efficacy of Silymarin 700 mg Capsules TID for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Silymarin as defined by an improvement in non-alcoholic steatosis (NAS) activity score by at least 30% from baseline compared to placebo
研究概览
简要总结
This is a randomised study to examine whether high dose Sillymarin will be able to help improve fat-induced liver damage in the liver. The study hypothesis is that high dose Sillymarin will be able to reduce steato-hepatitis (fat-related liver inflammation) better than placebo.
详细描述
OBJECTIVES OF STUDY Primary Objectives
- To assess the safety and adverse event profile of Silymarin compared to placebo.
- To assess the efficacy of Silymarin as defined by an improvement in non-alcoholic steatosis (NAS) activity score by at least 30% from baseline compared to placebo.
Secondary Objectives
- To compare NAS activity before and after Silymarin therapy.
- To characterize changes in ALT and AST during Silymarin therapy.
- To compare insulin resistance measured by HOMAr during Silymarin therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 or female 18 years of age or older.
- •Diagnosed with NASH (refer to Section 5.2)
- •AST and/or ALT greater than 40 IU/L.
- •Must agree to adhere to alcohol consumption guideline.
- •Weight gain//loss of no more than 10% between biopsy and screening or within 30 days of screening if the biopsy is performed during the screening period.
- •No change in diabetic and/or lipid medications between biopsy and screening or within 30 days of screening if the biopsy is performed during the screening period
排除标准
- •Use of silymarin or other milk thistle preparations for a period of 90 consecutive days or longer between biopsy and initial screening, or within 30 days prior to screening if the biopsy is performed during the screening period.
- •Use of other antioxidants or non-prescribed complementary alternative medications for a period of 90 consecutive days or longer between biopsy and initial screening, or within 30 days prior to screening if the biopsy is performed during the screening period.
- •Use of warfarin, metronidazole, or acetaminophen (greater than 2 grams per day) between screening and randomization.
- •Use of oral steroids for more than 14 days of screening or prior to randomization.
- •BMI ≥ 35 kg/m2 between screening and randomization.
- •Poorly-controlled diabetes (HbA1c > 8 %) between screening and randomization
- •Diabetes mellitus treated with oral agents other than the secretagogues or metformin between screening and randomization. Sitagliptin is allowed.
- •For patients using anti-hyperlipidemic agents or accepted anti-diabetic agents, any change of agent or dose between screening and randomization.
- •Radiologic imaging consistent with cirrhosis or portal hypertension.
- •Evidence of decompensated liver disease
- •Platelet count < 130 x 109 /L at screening.
- •History of bariatric surgery, or undergoing evaluation for bariatric surgery.
- •Known allergy/sensitivity to milk thistle or its preparations.
- •History of immunologically mediated disease
- •History of thyroid disease poorly controlled on prescribed medications.
- •History of solid organ or bone marrow transplantation.
- •Primary hepatic malignancy.
- •Secondary hepatic malignancy or extrahepatic malignancy.
- •Serum Creatinine of 176 μmol/L or greater or creatinine clearance (calculated according to Cockcroft-Gault) 60 mL/min or less, or on dialysis, at screening.
- •Severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study.
- •Women with ongoing pregnancy or breast feeding, or contemplating pregnancy.
- •Women of childbearing potential who are not practicing an acceptable form of birth control.
- •Participation in a research drug trial within 30 days of screening.
- •Inability or unwillingness to give informed consent or abide by the study protocol.
研究组 & 干预措施
Sillymarin
Experimental
Active component study medication
干预措施: Sillymarin (Drug)
Placebo
Placebo Comparator
Placebo capsules
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the efficacy of Silymarin as defined by an improvement in non-alcoholic steatosis (NAS) activity score by at least 30% from baseline compared to placebo
时间窗: 12 months
次要结局
- To assess the safety and adverse event profile of Silymarin compared to placebo(12 months)
研究者
研究点 (1)
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