Health Condition 1: K769- Liver disease, unspecified
Conditions
Interventions
Intervention1: Group A – LS/24-25/Liv001: 1 tablet twice a day for 90 days.
Intervention2: Group B - LS/24-25/Liv002: 1 tablet twice a day for 90 days.
Control Intervention1: Group C-Placebo: 1 tablet
Sponsors
Life Synergy
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 calculationTimepoint: 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
| Measure | Time frame |
|---|---|
| 1. Assessment of adverse events 2. Assessment of tolerability of investigational products. Timepoint: 1. From baseline to end of the study. 2. From baseline to end of the study. | — |
Countries
India
Contacts
Public ContactDr Vaishnavi Patil
Life Synergy
Outcome results
None listed