Health Condition 1: K758- Other specified inflammatory liverdiseases
Conditions
Interventions
Intervention1: Livitis®: One tablet twice a day after food for 90days.
Control Intervention1: Placebo: One tablet twice a day after food for 90days.
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient has given informed consent for participation in this study. 2.BMI between 25 to 35 kg/m2. 3.Patient with presence of mild to moderate steatosis NASH ( 4.Patient with controlled Diabetes, Hyper- lipidemia & Hypertension by stable dose for at least 3 months prior to screening.
Exclusion criteria
Exclusion criteria: 1.Patients having age below 30 and above 65 2.Pregnant and lactating females not included in this study. 3.HbA1c more than 7.2. 4.Patients having other systemic complications like hepatic, renal and cardiac problems 5.Patient with history of alcoholism 6.Those are not willing to participate in trial and not ready to give written consent. 7.History of renal, pulmonary, epileptic, hematologic, cardio -vascular, neurological or psychiatric illness and immuno -eficiency diseases 8.Patients who are currently participating in any other clinical trials (since last 3 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Mean change in ALT, AST. 2.Mean change in liver fat content as measured by Fibroscan with CAP.Timepoint: 1.Mean change in ALT, AST (Screening,Day30,Day60and Day90). 2.Mean change in liver fat content as measured by Fibroscan with CAP(Day0 and Day90). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean change in total bilirubin, alkaline phosphatase. 2.Mean changes in Lipid Profile. 3.Mean changes in Fasting glucose. 4.Mean change in HbA1c. 5.Mean changes in Biomarkers: IL-6, Adiponectin, hsCRP. 6.Mean change in BMI, Abdominal Circumference. 7.Safety outcome by incidence of AE.Timepoint: 1.Mean change in total bilirubin, alkaline phosphatase (Screening,Day30,day60 and Day90). 2.Mean changes in Lipid Profile(Screening,Day30,Day60 and Day90). 3.Mean changes in Fasting glucose(Screening,Day30,Day60 and Day90). 4.Mean change in HbA1c (Screening and Day90). 5.Mean changes in Biomarkers: IL-6, Adiponectin, hsCRP (Day0 and Day90). 6.Mean change in BMI, Abdominal Circumference(Screening and Day90). 7.Safety outcome by incidence of AE (Day30,Day60 and Day90). | — |
Countries
India
Contacts
Public ContactDr Kalpesh Shah
ClinWorld Private Limited
Outcome results
None listed