Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
None listed
Sponsors
Dr Madhura Dhatrak
DrSandip Mali
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or female participants aged 18-45 years diagnosed with NAFLD Grade II 2 Participants with abnormal liver function tests indicative of NAFLD 3 Completed the screening process within 3 days prior to randomization 4 Study participants have understood and signed the informed consent form to participate in the study 5 Study participants willing to be available for the entire study period and adhere to protocol requirements as evidenced by signing the informed consent document
Exclusion criteria
Exclusion criteria: KEY EXCLUSION CRITERIA - 1. Participants with significant hepatic disease other than NAFLD (e.g., viral hepatitis, alcoholic liver disease, Liver ci). 2. History of major gastrointestinal surgery or liver transplantation. 3. Pregnant or lactating women. 4. Concurrent use of hepatotoxic drugs or participation in another clinical trial within the past 30 days. 5.Alcohol consumption: Excessive alcohol consumption, defined as more than 20 grams per day for men and more than 10 grams per day for women, within two years of entry 6.Viral infection: Evidence of hepatitis B or C infection 7.Autoimmune or liver condition: History of autoimmune hepatitis, Wilson's disease, or other underlying liver conditions 8.Other conditions: Short bowel syndrome, suspected or confirmed hepatocellular carcinoma, HIV positivity, low alpha-1-antitrypsin level, glycogen storage disease, dysbetalipoproteinemia, phenotypic hemochromatosis, vascular lesions, iron overload, and more 9.Active drug use: Active drug use or dependence that would interfere with follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Mean change in liver function as assessed by Liver Function Tests over 90 days 2 Reduction in hepatic stiffness and scarring measured by Fibro scan at baseline and day 90 3 Improved digestive health using the Digestion associated quality of Life and Gastrointestinal Symptom Rating Scale 4 Changes in Lipid Profile over 90 daysTimepoint: 1 Screening Day Before 2 to 4 2 Visit 1 Day 0 Randomization in study 3. Visit 2 Day 30 4. Visit 3 Day 60 5. Visit 4 Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| SECONDARY ENDPOINT - 1. Safety evaluations based on hematological (ESR, Leukocyte) and renal function tests (RFTs) 2. Understand AEs and SAEs of liver care tablet over 90 daysTimepoint: 1. Screening (Day -2 to -4) 2. Visit 1(Day 0): Randomization in study 3. Visit 2 (Day 30) 4. Visit 3 (Day 60) 5. Visit 4 (Day 90) | — |
Countries
India
Contacts
Public ContactDr V R Borakhade
Yashwant Ayurvedic College PGTand RC Kodoli
Outcome results
None listed