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CTRI Number  CTRI/2022/10/046201 [Registered on: 06/10/2022] Trial Registered Prospectively
Last Modified On: 19/08/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical Trial of Liveril Forte Tablet in subjects with Non-Alcoholic Fatty Liver Disease. 
Scientific Title of Study   Randomized, placebo controlled, clinical study to assess the efficacy & safety of Liveril Forte Tablet in subjects with Non-Alcoholic Fatty Liver Disease. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/22-23/004 (Ver 1.0 dated 18th August 2022)  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V G Vaidya 
Designation  Managing Trustee 
Affiliation  Lokmanya Medical Research Centre and Hospital 
Address  Forth floor OPD 401 314 B Telco Road Chinchwad

Pune
MAHARASHTRA
411033
India 
Phone  9822057766  
Fax  -  
Email  vgvclinical@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Tania Dcruz 
Designation  Senior Medical Executive (Medical Services) 
Affiliation  Meyer Organics Pvt. Ltd. 
Address  A 303 Road No 32 Wagle Estate Thane

Mumbai
MAHARASHTRA
400 604
India 
Phone  912225817126  
Fax  9162757002  
Email  tdcruz@meyer.co.in  
 
Details of Contact Person
Public Query  
Name  Neepa Gaba 
Designation  Scientific coordinator 
Affiliation  Meyer Organics Pvt. Ltd. 
Address  A 303 Road No 32 Wagle Estate Thane

Mumbai
MAHARASHTRA
400 604
India 
Phone  912225817126  
Fax  9162757002  
Email  ngaba@meyer.co.in  
 
Source of Monetary or Material Support  
Meyer Organics Pvt. Ltd. A-177, Road No. 16/Z, Brodma, Neheru Nagar, Wagle Industrial Estate, Thane West, Mumbai, Maharashtra 400604 
 
Primary Sponsor  
Name  Meyer Organics Pvt Ltd 
Address  A-303, Road No. 32, Wagle Estate, Thane, Maharashtra- 400604 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr V G Vaidya  Lokmanya Medical Research Centre and Hospital  Forth floor OPD 401 314 B Telco Road Chinchwad Pune MAHARASHTRA 411033 India Pune MAHARASHTRA
Pune
MAHARASHTRA 		 9822057766
-
vgvclinical@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Liveril Forte Tablet along with diet and lifestyle changes.  One tablet of Liveril Forte once daily after main meal for 90 days. 
Comparator Agent  Placebo Tablet along with diet and lifestyle changes.  One Placebo Tablet once daily after main meal for 90 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Adults (age 18 to 60 years) both sex with BMI ≥25.00 and ≤32.00 kg/m2 2.Confirmed Diagnosis of NAFLD established by imaging (ultrasound, CT scan or MRI), within 3 months of the screening phase. The diagnosis of NAFLD is made according to the American Association for the Study of Liver Diseases (AASLD) criteria (Chalasaniet al.2017) defined as complying following-(a) There is hepatic steatosis by imaging or histology,(b) There is no significant alcohol consumption,(c) There are no competing etiologies for hepatic steatosis,(d) There are no co-existing causes for chronic liver disease;3.Liver steatosis grade I, II, and III by USG abdomen pelvis at screening Patient’s demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol-required evaluations;
4.With or without deranged liver function test with serum AST or ALT more than 1.5 times than upper range of normal values. 
 
ExclusionCriteria 
Details  1. Regular or excessive use of alcohol within 2 years prior to initial screening; 2. Presence of alternative causes of fatty liver; 3. Weight loss >10% in the 6 months before the screening visit;
4. Use of drugs associated with NAFLD for more than 12 consecutive weeks in the 1 year before start of the study, including amiodarone, tamoxifen, methotrexate, systemic glucocorticoids, anabolic steroids, tetracycline, estrogens in doses higher than used in oral contraceptives, valproate, chloroquine, or antiretroviral drugs;
5. History of bowel surgery, gastrointestinal (bariatric) surgery or undergoing evaluation for bariatric surgery for obesity, extensive small-bowel resection, or orthotopic liver transplants (OLT) or listed for OLT; 6. History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis; 7. Patient has known cirrhosis (compensated /decompensated) either based on clinical criteria or liver histology or imaging techniques; 8. Patients with unstable cardiovascular disease including, unstable angina, (i.e., new or worsening symptoms of coronary heart disease within the past 3 months), acute coronary syndrome within the past 6 months, acute myocardial infarction in the past 3 months or heart failure of New York Heart Association class (III – IV) or worsening congestive heart failure, or coronary artery intervention, within the past 6 months, uncontrolled hypertension (systolic BP>180 mmHg and/or diastolic BP >110 mmHg on two consecutive occasions), stroke or transient ischemic attack within the prior 6 months; 9. History of myopathies or evidence of active muscle disease;
10. History of malignancy in the past 5 years and/or active neoplasm; 11. Participation in any other therapeutic clinical study in the past 3 months, including participation in any other NAFLD clinical trials; 12. History of bladder disease and/or hematuria or has current hematuria except due to a urinary tract infection; 13. Illicit substance abuse within the past 12 months;
14. Pregnant/lactating female (including positive pregnancy test at the screening visit);
15. History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV, coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.NAFLD fibrosis score by calculation at screening and end of the study.
2.Liver Steatosis Grade I, II, and III by USG abdomen pelvis at screening and end of the study.
3.Severity grading of symptoms such as abdominal pain, abdominal tenderness, nausea,loss of appetite, fatigue, itchy skin, jaundice on 4 point Linkert scale (None, mild, moderate and severe)
 		 Screening, Day 30, Day 60 and Day 90 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1.Parameters of liver function test (LFT) like AST, ALT, ALP, GGT, bilirubin total, direct and indirect, albumin and globulin etc. at screening and end of the study.
2.Serum levels of insulin, fasting plasma blood sugar and HOMA-IR score.
3.Anthropometric parameters like body weight,
BMI, waist circumference at screening and end of the study.
4.Parameters in lipid profile like total cholesterol,
HDL, LDL, triglyceride etc. at screening and end of the study. 		 Screening, Day 30, Day 60 and Day 90 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   10/10/2022 
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="6"
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  

Nonalcoholic fatty liver disease (NAFLD) is a condition in which fat builds up in liver. Nonalcoholic fatty liver (NAFL) and nonalcoholic steatohepatitis (NASH) are types of NAFLD. NASH, witnesses’ inflammation and liver damage, along with fatty liver. Liveril Forte tablet is an advanced formulation that contains high strength Silymarin along with select micronutrients and antioxidants. Silymarin in Liveril Forte acts as a hepato-protectant, and optimizes the function of the liver. This tablet for liver is composed of ’Super Six’ hepato-protectants that act synergistically to stimulate the production of hepatocytes and removal of toxins from the liver. The Liveril tablet is useful for detoxifying the liver, and maintaining its health. Silymarin is a potent natural antioxidant, prevents liver damage caused by free radicals.  Silymarin increases the glutathione synthesis inside the liver cell. Silymarin helps in the production of new liver cells (by protein synthesis) to replace the damaged old ones.

Liveril forte tablet is a health supplement that helps to maintain healthy liver and for detoxification of liver. It is used for liver damage due to alcoholism, acute and chronic liver diseases, alcoholic fatty liver, detoxifying liver and high cholesterol. Natural antioxidants helps the liver to respond better against invading infections by neutralizing damage caused by free radicals (harmful chemicals).

medicinal  benefits

·       Silymarin acts as hepato-protectant and improves liver functioning.

·       Stimulates hepatocytes (liver cells) production and removal of toxins from liver.

·       Prevents liver damage caused by free radicals (harmful chemicals) as it contains Silymarin, a potent natural antioxidant.

·       Also, has potential of sensitizing production of new liver cells to replace damaged old ones. 


The present research is an attempt of clinical validation of Liveril Forte Tablet in patients suffering from NAFLD. With the present research we can apply the knowledge from nutritional benefits along with the clinical trials to address important medical need of NAFLD patients to improve liver function and to control the disease progression. There is need to do primary translational work earliest & focus at some targeted aim and come up with a formulation for same to improve steatosis, hepatic inflammation and fibrosis, while ameliorating associated symptoms, insulin resistance, glucose metabolism, and obesity and to prevent progression to cirrhosis of the liver. Which could be achieved through the present research. We can utilize these outcomes to develop a strategy for treating NAFLD in more appropriate and assured way.

 
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