A Phase II, Randomized, Double Blind, Placebo-Controlled Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients With Apparent Risk Factors of Nonalcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- explore the anti-oxidant activity of Heptex
研究概览
简要总结
A Phase II, Randomized, Double Blind, Placebo-Controlled Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients with Apparent Risk Factors of Nonalcoholic Steatohepatitis (NASH)
详细描述
This is a phase II, randomized, double blind placebo-controlled, three-arm, parallel-group, intervention clinical trial evaluating anti-oxidant activity of Heptex; a herbal medicinal product of Aerial Parts of Phyllanthus niruri (Dukung Anak) and Fruits of Silybum marianum (Milk Thistle) in patients with apparent risk factors of NASH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged between 18 and 65 years.
- •Both male and female patients who have childbearing potential must agree to practice an acceptable method of birth control during the study and for at least 6 months after the cessation of treatment; such contraceptive methods must include at least one barrier method.
- •Controlled Attenuation Parameter (CAP)-confirmed hepatic steatosis.
- •Patients with elevated serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels but less than 2.5 times the upper limit of the normal range.
- •Liver fibrosis stage F1-F2 as diagnosed by the FibroScan liver stiffness measurement of 5-10 kPa.
- •Liver condition according the following criteria;
- •Serum albumin > 3 g/dl
- •No ascites on ultrasound
- •No documented or suspected hepatic encephalopathy
- •Willing to stop any other liver support and hepatoprotective medications throughout study duration.
- •Able and willing to provide written informed consent.
- •Able and willing to complete all study visits and procedures, including compliance with the requirements and restrictions listed in the consentform.
排除标准
- •Pregnant or lactating women.
- •Patients with BMI > 40 Kg/m2 or BMI < 18.5 Kg/m
- •Serum creatinine > 1.5 x ULN OR creatinine clearance (GFR) < 60 mL/minute.
- •Platelet count < 75,000/mm
- •Uncontrolled diabetes mellitus as evident by HbA1c ≥ 8.5%.
- •Patients who are currently receiving Thiazolidinediones.
- •Patients with ischemic heart disease (IHD).
- •History of parenteral nutrition.
- •History of liver transplant.
- •Viral hepatitis, drug-induced liver injury, metabolic liver disease or auto-immune liver disease.
- •Liver cancer or serum alpha-fetoprotein (AFP) >100ng/ml. Patients with an AFP between 50 and 100ng/ml may be included as long as a liver ultrasound within 3 months of screening, or at screening, shows no evidence of potential hepatocellular cancer.
- •Use of drugs known to induce steatosis (valproate, amiodarone or prednisone) or to affect body weight and carbohydrate metabolism.
- •Use of drugs known to alter liver enzymes.
- •Allergy or allergic history to any of the drug components.
- •History of alcohol abuse as assessed by the investigator within the past 2 years, or an alcohol use pattern that may interfere with the patient's study compliance. Patients must have abstained from alcohol for at least 6 months prior to study start.
- •Patients with history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
- •Receipt of an investigational drug within 6 months prior to screening, or active enrolment in another investigational medication or device trial.
- •Patients with any chronic illness or prior treatment which in the opinion of the investigator should preclude participation in the trial.
- •Inability to understand and cooperate with the investigators or to give valid consent.
研究组 & 干预措施
Placebo
Placebo (Rice bran) in 2 capsules size 1, administered PO TID on empty stomach with plenty of water.
干预措施: Rice bran (Other)
Heptex-low dose
Low dose The contents of one capsule of Heptex is equally distributed and inserted into 2 capsules size 1, administered PO TID on empty stomach with plenty of water.
干预措施: Heptex (Drug)
Heptex-high dose
High dose The contents of two capsule of Heptex is equally distributed and inserted into 2 capsules size 1, administered PO TID on empty stomach with plenty of water.
干预措施: Heptex (Drug)
结局指标
主要结局
explore the anti-oxidant activity of Heptex
时间窗: 36 weeks
assessed by the change in serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels in patients with apparent risk factors of NASH.
次要结局
- explore the hepatoprotective effect of Heptex(36 weeks)