CTRI/2022/07/044203招募中3 期
A Prospective, Randomized, Double-Blind, Two-Arm, Placebo-Controlled Comparative Clinical Study to Evaluate the Safety and Efficacy of Liv.52 Tablets in Alcoholic Liver Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients of either gender aged >18 to <65 years.
- •2.Patients diagnosed as Alcoholic Liver Disease (ALD) ? on the basis of all of the following criteria:
- •a.Patient with a history of alcohol use based on AUDIT (Alcohol Use Disorders Inventory Test) questionnaire (A total sum of >8 for men and >4 for women)
- •b.Ongoing consumption of Alcohol or Active alcohol use until 4 weeks prior to screening.
- •c.Patients with elevated liver function test (ALT and AST >1.5 times of upper limit of normal (ULN) & GGT > 2.5 ULN)
- •d.Ultrasound evidence of fatty liver (steatosis) and / Hepatitis.
- •e.Maddrey Discriminant function (DF) less than 32.
- •3.Patient has not participated in a similar investigation in past four weeks.
- •4.Presenting with one or more clinical symptoms of Alcoholic liver disease like nausea, loss of appetite, jaundice, fatigue, abdominal discomfort, increased thirst, swelling, weight loss (due to loss of proximal muscle mass), weakness, mood swings, bleeding gums, dysphagia, Weight gain (due to ascites), confusion, amenorrhea etc
- •5.Ability to understand and willing to give a written informed consent prior to any study-related procedures and ready to follow and in agreement to visits as per the study assessment visits
- •6.Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 15 days following completion of therapy.
- •Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •a.Has not undergone a hysterectomy or bilateral oophorectomy; or
- •b.Has not been postmenopausal for at least 12 consecutive months
排除标准
- •1.Severe alcoholic hepatitis with cirrhosis or any of its complications (e.g., Hepatocellular Carcinoma, Portal hypertension, uncontrolled infection, Acute Kidney Injury etc.)
- •2.Patient with other cause of Chronic Liver Disease (Nonalcoholic fatty liver disease (NAFLD), Autoimmune Liver Disease, Wilson Disease, Viral Hepatitis (HBV, HCV), hemochromatosis) and metabolic syndrome
- •3.Hepatic disorders due to cardiac causes, inherited metabolic causes.
- •4.Participants with active viral hepatitis.
- •5.Undergoing active treatment for alcohol withdrawal syndrome (AWS) at the study entry.
- •6.Participants on hepatotoxic medications like antitubercular medication, antiviral medication.
- •7.Severe cases of ascites, (however, Grade I & II as per CTCAE criteria can be enrolled.) hepatic encephalopathy, varices, or bleeding.
- •8.Subjects with elevated liver function test ALT and AST > 5 times of upper limit of normal (ULN)
- •9. Patients are on treatment for AUD (Alcohol Use Disorder)
- •10. Pregnant or lactating women or who don’t want to follow the effective contraception measures.
研究者
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