CTRI/2022/08/044545 [Registered on: 01/08/2022] Trial Registered Prospectively
Last Modified On:
01/03/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Other (Specify) [Phase IV]
Study Design
Single Arm Study
Public Title of Study
Clinical Trial to evaluate the Safety and Effectiveness of Liv.52 DS Tablets in various Liver disorders
Scientific Title of Study
An Open-Label, Multi-Centre, Phase IV Study to evaluate the Safety and Effectiveness of Liv.52 DS Tablets in varied Hepatic disorders
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
HWC/MSCD/PP/043/2021, Version 01, Dated 11 May 2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Sanjay Ambhore
Designation
Senior Consultant Physician
Affiliation
Shreya Clinic
Address
Ground Floor, Om Shiv Nagar, Gufa Mandir Main Road, Lalghati, Bhopal-462030, Madhya Pradesh, India.
Bhopal MADHYA PRADESH 462030 India
Phone
9303109655
Fax
0755-2665014
Email
sanjay.ambhore18@gmail.com
Details of Contact Person Scientific Query
Name
Dr Rajesh Kumawat
Designation
Head – Medical Services & Clinical Development
Affiliation
Himalaya Wellness Company
Address
Room No 301, 3rd Floor, Clinical Pharmacology, Research and Development Makali, Tumkur Road, Bangalore Rural, KARNATAKA – 562162, India.
Bangalore Rural KARNATAKA 562162 India
Phone
08067549904
Fax
Email
rajesh.kumawat@himalayawellness.com
Details of Contact Person Public Query
Name
Dr Soorya Narayan
Designation
Manager- Clinical Operations
Affiliation
Himalaya Wellness Company
Address
Room No 301,3rd Floor, Clinical Pharmacology, Research and Development Makali, Tumkur Road, Bangalore Rural, KARNATAKA – 562162, India
Bangalore Rural KARNATAKA 562162 India
Phone
08067549919
Fax
Email
dr.sooryanarayan.h@himalayawellness.com
Source of Monetary or Material Support
Himalaya Wellness Company
NH 4, Makali, Tumkur Road, Makali Aluru Main Road Opposite to JCB Bangalore Rural, Karnataka, 562162, India
Primary Sponsor
Name
Himalaya Wellness Company
Address
NH 4, Makali, Tumkur Road, Makali Aluru Main Road Opposite to JCB
Bangalore Rural, Karnataka, 562162, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
JSS Medical Research Asia Pacific Private Limited
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad -121003, Haryana, India
66B, Besides all india reporter building, Humpyard road, Ajni railway station road, Congress Nagar, Opp Metro pillar no-P277, Nagpur-440012 Nagpur MAHARASHTRA
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
o Alcoholic fatty liver (steatosis)
o Alcoholic hepatitis
• NAFLD
o Steatosis
• 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
o Any 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.
ExclusionCriteria
Details
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 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].
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).
Method of Generating Random Sequence
Not Applicable
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1. Percentage of patients showing improvement in clinical signs and symptoms.
2. Percentage of patients showing improvement in Hepatic Laboratory Parameters at EOS.
3. Percentage of patients showing improvement in quality of life (QOL) as per questionnaire.
12 Weeks
Secondary Outcome
Outcome
TimePoints
Incidence of adverse events (AEs) after Liv.52 DS administration.
12 Weeks
Target Sample Size
Total Sample Size="1000" Sample Size from India="1000" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 4
Date of First Enrollment (India)
10/08/2022
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="10" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Nil
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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.