Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: SAROGLITAZAR
: DOSE- 4MG (TABLET)
FREQUENCY- OD
DURATION- 45 DAYS
Control Intervention1: NOT APPLICABLE: NOT APPLICABLE
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of both gender and aged above 18 to 75 years. 2. A diagnosis of NAFLD established by fibro scan. Body mass index more than 25 kg per meter square Stable body weight change less than plus or minus 10 percentage of body weight for 3 months before the study. 3. Central obesity: Waist circumference 90 cm or greater in men or 80 cm or greater in women Elevated fasting plasma glucose: fasting plasma glucose of 100 mg per dL or greater or HBA1c greater than 6.5 percentage 4. Patients with Elevated triglycerides serum triglycerides 150 mg per dL or greater or Reduced high-density lipoprotein cholesterol serum HDL-c less than 40 mg per in men or less than 50 mg per dL in women; or Elevated blood pressure systolic blood pressure of 130 mmHg or greater or diastolic blood pressure of 85 mmHg or greater are included. 5. Patients who are able and willing to provide informed consent.
Exclusion criteria
Exclusion criteria: 1.Metabolic syndrome patients with HbA1c greater than 9 percent and or use of thiazolidinediones like pioglitazone, rosiglitazone, CYP2C8 inhibitors , fibrates like clofibrate, fenofibrate. 2. Patients having vitamin E greater than 100 IU per day administration, or multivitamins containing greater than 100 IU per day of vitamin E in the 3 months prior to the screening visit. 3. Patients with known cardiovascular and cerebrovascular diseases like coronary heart disease, stroke, or revascularization and malignant tumours. 4. Patients having other chronic liver disease and established diagnosis of cirrhosis . 5. Patient with acute or chronic viral infection within the previous 4 weeks. 6. Alcohol abuse of weekly consumption of alcohol is more than 70 g in women or 140 g in men.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Efficacy of SAROGLITAZOR in controlling fatty liver progression and rapid recovery from symptoms. The change in CAP SCORE from GRADE 1 (5 - 33 percentage) to normal (less than 5 percentage) Timepoint: DAY 1 ( BASELINE VALUE) DAY 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the metabolic syndrome severity score saroglitazar 4mg before and after administration. To check body weight, waist hip ratio, blood pressure, glycemic control To find out, incidence of adverse events during the study period Timepoint: DAY 1 ( BASELINE VALUE) DAY 45 | — |
Countries
India
Contacts
Public ContactDr T M Vijaykumar
SRM, Medical college ,SRMIST
Outcome results
None listed