NCT01680003Unknown2 期
A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy and Safety of HEPAR-P Capsule 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
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Improvement in serum aspartate aminotransferase and alanine aminotransferase levels
研究概览
简要总结
This is a multi-center, double blind, parallel group placebo controlled randomised trial designed to determine the safety and efficacy of a Standardised Extract of Phyllanthus Niruri (EPN 797) HEPAR-P capsule for the treatment of Non-alcoholic Fatty Liver Disease for a treatment period of 48 weeks
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant females age 18 years or older
- •Written informed consent obtained from patient or parents/ guardian
- •Elevated serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels but less than 2.5times the upper limit of the normal range
- •Patients with liver biopsy confirmed possible or definite steatohepatitis within the past 12 months prior to enrolment into the trial
- •Possible steatohepatitis with activity score ≥3 OR definite steatohepatitis with activity score ≥5
- •A score of at least 1 for hepatocellular ballooning
排除标准
- •Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test
- •Participation in any trial in which the patient received an investigational product within 30 days preceding the screening phase of this study
- •Those persons directly involved in the conduct of the study
- •Alcohol consumption of more than 20g per day for women or more than 30g per day for men for at least 3 consecutive months during the previous 5 years, as assessed with the use of the Lifetime Drinking History questionnaire and the interview version of the Alcohol Use and Disorders Identification Test (AUDIT)
- •History of cirrhosis, hepatitis C or other liver diseases
- •History of heart failure (New York Association Class II to IV)
- •History of taking medications known to cause steatohepatitis
- •Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study
研究组 & 干预措施
Hepar-P
Experimental
Hepar-P: Two capsules (250mg x 2), three times daily, orally
干预措施: Hepar-P (Drug)
Placebo for Hepar-P
Placebo Comparator
Placebo: Two capsules, three times daily, orally
干预措施: Placebo for Hepar-P (Drug)
结局指标
主要结局
Improvement in serum aspartate aminotransferase and alanine aminotransferase levels
时间窗: 48 weeks
次要结局
- Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score(48 weeks)
研究者
研究点 (5)
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