Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Group A: Test NAFLD participants: Group A: Participants will receive Pravekliv tablet at a total daily dose of
2 tablets at each time, administered orally for twice a day, before a
b
Sponsors
Pravek Kalp Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged between 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/m 2. Applicable for groups A & B only (NAFLD): 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. Applicable for groups C & D only (ALD): Confirmed Diagnosis of ALD established by imaging (ultrasound, CT scan, or MRI), within 3 months of the screening phase for this study. Evidence of alcoholic liver disease (ALD) based on a thorough history, physical examination, and laboratory tests and all of the following: a) Chronic alcohol intake, Identified with AUDIT (Alcohol Use Disorder Inventory Test) Questionnaire b) Active alcohol use until 4 weeks before screening c) ALT and AST elevated 1.5 times the upper limit of normal d) Over 1.5 ratio of AST to ALT. 4. Participants demonstration of understanding of study requirements and treatment procedures, and willingness to comply with all protocol required evaluations.
Exclusion criteria
Exclusion criteria: 1. Participants with the presence of alternative causes of fatty liver 2. Participants with a weight loss 10% in the 6 months before the screening visit 3. Participants with a HbA1c 6.5% and fasting blood glucose 125 mg/dL 4. Use of drugs associated with ALD/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. Participants with a 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. Participants with a 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 /decompensated) either based on clinical criteria or liver histology or Imaging techniques 8. Participants 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. Participants with a history of myopathies or evidence of active muscle disease 10. Participants with a 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/NAFLD clinical trials 12. Participants with a history of bladder disease and/or haematuria or have current haematuria except due to a urinary tract infection 13. Illicit substance abusers within the past 12 months 14. Pregnant/lactating female (including positive pregnancy test at the screening visit) 15. Participants with a 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. Assessment of Liver Steatosis Grade I, II, and III by USG abdomen pelvis will be done at screening and day 90. 2. Assessment of severity grading of symptoms such as abdominal pain, abdominal tenderness, nausea, loss of appetite, fatigue, itchy skin, andjaundice on a 4-point Linkert scale (None, mild, moderate, and severe) will be done at screening, baseline, day 30, day 60, and day 90. 3. Assessment of liver function tests like Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma-glutamyl transferase (GGT), bilirubin total, direct and indirect, albumin, and globulin will be done at screening and day 90. Timepoint: screening, baseline, day 30, day 60, and day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of serum levels of fasting insulin, fasting plasma blood sugar, and calculated HOMA-IR score (insulin resistance) will be done at screening and day 90. 2. Assessment of anthropometric parameters like body weight, BMI, and waist circumference will be monitored at screening and day 90. 3. Assessment of parameters of lipid profile like total cholesterol, High Density Lipoprotein (HDL), low-density Lipoprotein (LDL), and triglyceride will be done at screening and day 90. 4. Assessment of the Fibrosis Index/score will be done at baseline and day 90.Timepoint: screening, Baseline and day 90 | — |
Countries
India
Contacts
Public ContactMr Arijeet Bhattacharjee
Pravek Kalp Private Limited
Outcome results
None listed