Antioxidant for Improvement of Hepatic Function in Patients With Alcohol Liver Disease Without Cirrhosis: Non-randomized Interventional Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in ALT(Alanine Aminotransferase)
研究概览
简要总结
Alcoholic liver disease represents the major health issues and it ranges from simple steatosis to cirrhosis. There is a paucity of data to support the allopathic intervention among these group of patients. Livitol-17 consist of the 3 whole herbs and extract which has antioxidant, hepatoprotective as well as reno-protective properties. The aim of this trial is to study the efficacy of herbal supplement to improve the liver function of alcoholic liver disease subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Adults aged over 18 years with the evidence of alcoholic liver disease (ALD) based on a thorough history, physical examination, and laboratory tests and all of the following:
- •Chronic alcohol intake, Identified with AUDIT(Alcohol Use Disorder Inventory Test) Questionnaire
- •Active alcohol use until 4 weeks prior to presentation
- •ALT and AST elevated >1.5 times the upper limit of normal
- •Over 1.5 ratio of AST to ALT
- •Maddrey Discriminant function(DF) less than 30
排除标准
- •Severe alcoholic hepatitis with cirrhosis or life expectancy less than 3 months
- •Severe renal impairment (Glomerular filtration rate below 60 ml/min per 1.73m2)
- •Hepatic disorders due to cardiac causes, inherited metabolic causes, hemochromatosis and Wilson's disease
- •Participants with active viral hepatitis
- •Under going active treatment for alcohol withdrawal syndrome(AWS) at the study entry
- •Participants on hepatotoxic medications like antitubercular medication, antiviral medication, paracetamol etc.
- •Pregnant, attempting to conceive, or lactating women
- •Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
研究组 & 干预措施
Intervention Group
All the eligible participants will receive Livitol-17 capsules. It consist of 390 mg of whole herbs and extract of Phyllanthus niruri (Bhumyamalaki), Boerhaavia diffusa (Punarnava) and Picroorrhiza kurroa (Katuki).
干预措施: Livitol-70 (Drug)
结局指标
主要结局
Change from baseline in ALT(Alanine Aminotransferase)
时间窗: 3 months
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in AST(Aspartate Aminotransferase)
时间窗: 3 months
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in ALP(Alkaline Phosphatase)
时间窗: 3 months
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Number of Subject with adverse events
时间窗: 3 months
Adverse events is defined as any untoward medical occurrence that may not necessarily have a causal relationship with the treatment, but resulted in a dose reduction or discontinuation of treatment.
Change from baseline in GGT(Gamma Glutamyl Transferase)
时间窗: 3 months
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in serum total bilirubin
时间窗: 3 months
The above mentioned test will be measured with panel of Liver function test at central laboratory.
次要结局
- Change in radiological response(3 months)
- Change in maddrey discriminant function(DF)(3 months)