A prospective single centre observational study to evaluate effectiveness and safety of Saroglitazar 4mg Vs Obeticholic acid 10 mg in pateints with non alcoholic fatty liver disease ( NAFLD)/ Non alcoholic Steatohepatitis (NASH).
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.Change in liver fat content by non-invasively measuring CAP parameters through Fibroscan at week 8 16week 24 weeks
研究概览
简要总结
METHODOLOGY
This is a single centre prospective, double arms, randomised observational study to evaluate the safety and efficacy of Saroglitazar 4mg and OCA 10mg in patients with NAFLD/NASH in real life setting.
This is a randomized, open-label, single center study. Patients are randomized to two treatment arms.
Arm I: Patients receives Saroglitazar 4mg once daily and moderate physical activity of 30 minutes 5
dyas a week.
Arm II: Patients receives OCA 10 mg once daily and moderate physical activity of 30 minutes 5 days
a week.
Patients are randomized in 1:1 ratio in both the arms and the planned sample size of 100 (50 each arm) subjects, considering 30-35% dropouts by end of the trial.
Diet and Exercise- All patients must maintain lifestyle modifications, including diet and exercise as advised by physician for the duration of the study. Patients should make no major changes in the type or amount of exercise in which they partake during the study.
Baseline Investigations
- Hemogram.
i. Hemoglobin.
ii. Platelet count.
iii. WBC (White blood cell) count.
iv. Differential WBC count.
- Liver Function Tests.
i. AST (Aspartate aminotransferase).
ii. ALT (Alanine aminotransferase).
iii. ALP (Alkaline phosphatase).
iv. Bilirubin.
v. Total protein.
vi. Albumin.
-
Fasting
-
Lipid profile
Blood Sugar / HbA1c.
i. Total cholesterol.
ii. HDL (High density lipoprotein) cholesterol.
iii. Direct LDL (Low density lipoprotein) cholesterol
iv. TG (Triglycerides).
-
Hepatic steatosis measured by CAP score
-
Hepatic Fibrosis measured by LSM
-
Height and Weight
-
Pregnancy Test
Follow up Investigations [At week 24 & 52]
 Patients will be clinically examined. Safety and efficacy parameters will be assessed as given below.
-
ALT
-
AST
-
Albumin
-
Platelet Count
-
Fasting Blood Sugar.
-
Lipid profile
i. HDL (High density lipoprotein) cholesterol.
ii. Direct LDL (Low density lipoprotein) cholesterol
iii. TG (Triglycerides).
-
Hepatic steatosis measured by CAP score
-
Hepatic Fibrosis measured by LSM
-
Weight
-
Any Significant side effect associated with drug
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults (age 18 to 60) being managed or treated for NAFLD.
- •â€¢The patient must qualify for NAFLD, according to the American Association for the Study of Liver Diseases (AASLD) criteria (Chalasani et al.2017).
- •â€¢(a) There is hepatic steatosis by imaging or histology, •(b) There is no significant alcohol consumption, •(c) There are no competing aetiologies for hepatic steatosis •(d) There are no co-existing causes for chronic liver disease.
- •â€¢Patient’s demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol-required evaluations.
- •â€¢The subjects underwent Fibroscan per the protocol described prior to enrolment and subsequently, they were contacted to participate in the follow-up study at 24 .
- •â€¢The lipid profile range in the inclusion criteria.
排除标准
- •Presence of regular or excessive use of alcohol within 2 years prior to initial screening.
- •Presence of alternative causes of fatty liver, including: History of bowel surgery, gastrointestinal (bariatric) surgery or undergoing evaluation for bariatric surgery for obesity, extensive small-bowel resection, or orthotopic liver transplants (OLT) History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis.
结局指标
主要结局
1.Change in liver fat content by non-invasively measuring CAP parameters through Fibroscan at week 8 16week 24 weeks
时间窗: 6months
Primary Endpoints
时间窗: 6months
2.Change in hepatic fibrosis assessed by non-invasively measuring LSM parameters through Fibroscan at baseline ,week 8, 16 and 24
时间窗: 6months
3.To assess the change in non-invasive scoring methods like NAFLD fibrosis score, FIB 4 Score, BARD Score and FAST Score at baseline, 16 and 24 weeks
时间窗: 6months
4.Compare the overall treatment efficacy in patients with NAFLD/ NASH treated with Saroglitazar magnesium 4mg and OCA 10mg.
时间窗: 6months
次要结局
- Secondary Endpoints