Clinical Trial of Liveril Forte Tablet in subjects with Non-Alcoholic Fatty Liver Disease.
- Conditions
- Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
- Registration Number
- CTRI/2022/10/046148
- Lead Sponsor
- Meyer Organics Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Adults (age 18 to 60) 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 Patientââ?¬•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.
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 ââ?¬â?? 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.NAFLD fibrosis score by calculation at screening and end of the study. <br/ ><br>2.Liver Steatosis Grade I, II, and III by USG abdomen pelvis at screening and end of the study. <br/ ><br>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)Timepoint: Screening, Day 30, Day 60 and Day 90
- Secondary Outcome Measures
Name Time Method 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. <br/ ><br>2.Serum levels of insulin, fasting plasma blood sugar. <br/ ><br>3.Anthropometric parameters like body weight, BMI, waist circumference at screening and end of the study. <br/ ><br>4.Parameters in lipid profile like total cholesterol, HDL, LDL, triglyceride etc. at screening and end of the study. <br/ ><br>Timepoint: Screening, Day 30, Day 60 and Day 90