An Open-Label, Multi-Centre, Phase IV Study to evaluate the Safety and Effectiveness of Liv.52 DS Tablets in varied Hepatic disorders

Himalaya Wellness Company0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•1. Patients of either gender aged >=18 to <= 60 years.
•2. Patients presenting with one or more clinical signs/symptoms like Fatigue, Nausea, Anorexia, Abdominal Pain/ Discomfort, Muscle Cramps, Localized edema, Jaundice or any other signs and symptoms which are related to one or more of the following mild to moderate hepatic disorder.
•Alcoholic liver disease
•oAlcoholic fatty liver (steatosis)
•oAlcoholic hepatitis
•Drug induced hepatotoxicity
•o Stage 1: mild fibrosis without walls of scarring
•o Stage 2: mild to moderate fibrosis with walls of scarring
•o Stage 3: bridging fibrosis or scarring that has spread to different parts of the liver but no cirrhosis
•oAny other mild-moderate/ non-serious hepatic disorder/ other hepatic infections to any other conditions.
•3. Patient
•o Has not participated in a similar investigation in past eight weeks.
•4. Ability to understand and willing to give written informed consent.
•5. 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 and for the duration of study participation.

•1. Any severe hepatic condition or any complications such as. Hepatocellular Carcinoma, Portal hypertension, Spleen enlargement, Hepatic encephalopathy, Confusion, Swelling/ Bleeding from veins, fluid accumulation in the abdomen.
•2. Patients having NASH with Cirrhosis
•3. Patients with normal LFT as confirmed by Central Lab results during screening. . However, waiver can be granted on case-to-case basis.
•4. Patients with any other clinically significant disease(s) which, in the opinion of the Investigator, could compromise the patientâ??s involvement in the study or overall interpretation of the data. [for e.g. uncontrolled hematologic, renal, hepatic, endocrine, neurologic, psychiatric, malignancy, metabolic, pulmonary, cardiovascular disease/impaired functioning or history of any autoimmune disease].
•5. Undergoing active treatment for alcohol withdrawal syndrome (AWS) at the study entry.
•6. Pregnant or lactating women.
•7. Patients who are already taking Liv.52 DS and found to be not effective.
•8. Patients with elevated liver function test of ALT and AST > 5 times of upper limit of normal.
•9. Other Laboratory Screening Results:
•Total white blood cells (WBC) <3,000 cells/mm3
•Absolute neutrophil count (ANC) <1,500 cells/mm3
•Platelet count <1,00,000/mm3
•Serum creatinine >2mg/dL or creatinine clearance <60ml/min (based on MDRD).

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