Clinical Trial to evaluate the Safety and Effectiveness of Liv.52 DS Tablets in various Liver disorders

Phase 4

Not yet recruiting

• Conditions: Liver disorders in diseases classified elsewhere,

• Registration Number: CTRI/2022/08/044545
• Lead Sponsor: Himalaya Wellness Company

Brief Summary

**STUDY OBJECTIVE:** The objective of this Phase-IV study is to evaluate the safety and effectiveness of Liv.52 DS tablets in patients presenting with various signs and symptoms of hepatic disorders.

**STUDY DESIGN:** An Open-Label, Multi-Centre, Phase IV study

**Study duration:** Duration of the study intervention will be for 12 weeks.

**Number of Subjects:** 1000 subjects will be enrolled.

**Study Site:** The study will be conducted at Approximately 32 sites.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-08
• Last Update Posted: 2023-01-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients of either gender aged ≥18 to ≤ 60 years.
• 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 • NAFLD oSteatosis • Drug induced hepatotoxicity •Hepatitis 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.
• Patient o Has not participated in a similar investigation in past eight weeks.
• Ability to understand and willing to give written informed consent.
• 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.

Exclusion Criteria

• 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.
• 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.
• Patients with any other clinically significant disease(s) which, in the opinion of the Investigator, could compromise the patient’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].
• Undergoing active treatment for alcohol withdrawal syndrome (AWS) at the study entry.
• Pregnant or lactating women.
• Patients who are already taking Liv.52 DS and found to be not effective.
• Patients with elevated liver function test of ALT and AST > 5 times of upper limit of normal.
• 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Percentage of patients showing improvement in clinical signs and symptoms.	12 Weeks
2. Percentage of patients showing improvement in Hepatic Laboratory Parameters at EOS.	12 Weeks
3. Percentage of patients showing improvement in quality of life (QOL) as per questionnaire.	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs) after Liv.52 DS administration.	12 Weeks

Trial Locations

Locations (40)

Apna Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Balaji Children Hospital; 🇮🇳 Bhopal, MADHYA PRADESH, India

Brij Medical Centre Pvt Ltd; 🇮🇳 Nagar, UTTAR PRADESH, India

Chandra Clinic; 🇮🇳 Jaipur, RAJASTHAN, India

Charak Hospital & Research Centre; 🇮🇳 Bhopal, MADHYA PRADESH, India

Chest Care Clinic; 🇮🇳 Nagar, UTTAR PRADESH, India

Citizen Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Diabetes Care and Hormone Clinic; 🇮🇳 Ahmadabad, GUJARAT, India

Dr. Ambedkar Medical College; 🇮🇳 Bangalore, KARNATAKA, India

Dr. Anil Batra clinic; 🇮🇳 Bhopal, MADHYA PRADESH, India

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Apna Clinic

🇮🇳Mumbai, MAHARASHTRA, India

Dr Aditya B Dixit

Principal investigator

9930339007

dradidixit@gmail.com