FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076500 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study of nutraceuticals in participants with non-alcoholic fatty liver disease  
Scientific Title of Study   A randomized, double blind, placebo-controlled clinical study evaluating the effects of nutraceuticals in participants with non-alcoholic fatty liver disease (NAFLD). 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/038 Version: 1.00 Dated: 14/10/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramshyam Agarwal 
Designation  Principal Investigator 
Affiliation  Lokmanya Medical Research Centre and Hospital 
Address  Fourth floor OPD 401 314 B Telco Road Chinchwad

Pune
MAHARASHTRA
411033
India 
Phone  8087282022  
Fax  -  
Email  ramshyam.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vaishnavi Patil 
Designation  Project Coordinator 
Affiliation  Life Synergy 
Address  Office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner

Pune
MAHARASHTRA
411045
India 
Phone  9834585994  
Fax  -  
Email  vaishnavilifesynergy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vaishnavi Patil 
Designation  Project Coordinator 
Affiliation  Life Synergy 
Address  Office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner


MAHARASHTRA
411045
India 
Phone  9834585994  
Fax  -  
Email  vaishnavilifesynergy@gmail.com  
 
Source of Monetary or Material Support  
Life Synergy office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner, Pune 411045, Maharashtra. 
 
Primary Sponsor  
Name  Life Synergy 
Address  office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner, Pune 411045, Maharashtra 
Type of Sponsor  Other [Nutraceutical product promoter] 
 
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 Ramshyam Agarwal  Lokmanya Medical Research Centre and Hospital  Fourth floor OPD 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA 		 8087282022
-
ramshyam.research@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of 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: K769||Liver disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A – LS/24-25/Liv001  1 tablet twice a day for 90 days. 
Intervention  Group B - LS/24-25/Liv002  1 tablet twice a day for 90 days. 
Comparator Agent  Group C-Placebo  1 tablet twice a day for 90 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adults aged 18 to 60 years (both inclusive), with a Body Mass Index (BMI) ranging from greater than or equal to 25.00 to less than or equal to 32.00 kg per meter square. 2. Confirmed Diagnosis of NAFLD established by imaging (ultrasound, CT scan or MRI), within 3 months of the screening phase for this study. 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 e) With or without deranged liver function tests, defined as serum Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) levels more than 1.5 times the upper limit of normal values. 3. Participant’s demonstration of understanding of study requirements and treatment procedures, and willingness to comply with all protocol required evaluations. 
 
ExclusionCriteria 
Details  1. Presence of alternative causes of fatty liver including heavy consumption of alcohol
2. Weight loss greater than 10 percent in the 6 months before the screening visit
3. HbA1c greater than 6.5 percent and fasting blood glucose greater than 125 mg per dL
4. Use of drugs associated with ALD or NAFLD for more than 12 consecutive weeks in the 1 year before the 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 diseases (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis
7. Participant has known cirrhosis (compensated or decompensated) either based on clinical criteria or liver histology or Imaging techniques
8. Participants with unstable cardiovascular disease including, unstable angina, (that is 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 greater than 180 mmHg and or diastolic BP greater than 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 ALD or 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 or 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 participant, in the investigators opinion, 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. Liver Steatosis Grade I, II, and III by USG abdomen pelvis
2. Severity grading of symptoms such as abdominal pain, abdominal tenderness, nausea, loss of appetite, bloating, fatigue, itchy skin, and jaundice on the 4 point Linkert scale (None, mild, moderate and severe)
3. Parameters of liver function test (LFT) like AST, ALT, ALP, bilirubin total, direct and indirect, albumin and globulin
4. Serum levels of fasting insulin, fasting plasma blood sugar, and calculated HOMA IR score (insulin resistance)
5. Anthropometric parameters like body weight, BMI, and waist circumference
6. Parameters in lipid profile like total cholesterol, HDL, LDL, and triglyceride
7. Fibrosis Index or score by calculation  		 1. At screening and end of the study.
2. On screening, baseline, and every follow up visit (day 30, day 60, and day 90).
3. At screening and end of the study.
4. At screening and end of the study
5. At screening and end of the study.
6. At screening and end of the study.
7. At baseline and end of the study.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessment of adverse events
2. Assessment of tolerability of investigational products.
 		 1. From baseline to end of the study.
2. From baseline to end of the study. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 2 
Date of First Enrollment (India)   12/11/2024 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Nutraceuticals, bioactive compounds derived from food sources, have shown promise in managing non-alcoholic fatty liver disease (NAFLD), a condition characterized by excessive fat accumulation in the liver not linked to alcohol consumption. Numerous studies suggest that nutraceuticals may offer therapeutic benefits due to their antioxidant, anti-inflammatory, and lipid-lowering properties. Moreover, nutraceuticals appear to exert beneficial effects on insulin resistance, lipid metabolism, and oxidative stress, all of which play a role in NAFLD progression. Nutraceuticals represent a complementary approach to standard interventions like diet, exercise, and pharmacotherapy for managing NAFLD. 
Close