Study to Compare the Efficacy & Safety of Ursoplus Capsules vs. UDCA vs. Placebo Among Chronic Liver Disease Patients

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to compare the efficacy & safety of Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) versus UDCA alone versus Placebo among Compensated Chronic Liver Diseased Patients

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MinaPharm Pharmaceuticals

Criteria

Inclusion Criteria:

1. Male and female patients aged ≥ 18

2. Subjects with Compensated Chronic Liver Disease, defined as child 5-7.

3. Patients with mild disturbance of liver biochemical profile (elevated Total Serum Bilirubin ≤ 3 mg/dl, or elevated Direct Serum Bilirubin ≤ 2 mg/dl, or elevated one or more of liver enzymes, up to 3 times of the normal level (Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) & Gamma Glutamyl Transpeptidase (GGT)).

4. Non-diabetic subjects and subjects with Controlled DM-type 1 and 2 patients, HbA1C up to 7.5%

5. Non-pregnant or lactating female patients

6. Subjects who are willing to sign Informed Consent Form (ICF) and ready to comply with the protocol for the duration of the study

Exclusion Criteria:

1. Subjects with a history of hypersensitivity to any of the ingredients of the medications being studied

2. Subjects with positive PCR/or antibodies to Hepatitis C in the past 6 months

3. Subjects with positive hepatitis B surface antigen (HBsAg)

4. Subjects with elevated liver enzymes more than 3 times of the normal level Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) & Gamma Glutamyl Transpeptidase (GGT).

5. Subjects with Primary Biliary Cirrhosis (PBC) and Primary Sclerosing Cholangitis (PSC).

6. Subjects with Child Pugh Score more than 7.

7. Subjects with history of bleeding varices.

8. Subjects having uncontrolled Diabetes (HbA1cmore than 7.5 %)

9. Subjects with any medical condition requiring the usage of medication that may interfere with the absorption, distribution, metabolism or excretion of the study drug such as:

1. Bile acid sequestering agents such as cholestyramine and colestipol.

2. Antacids containing aluminum hydroxide.

3. Drugs affecting lipid metabolism such as estrogens, oral and hormonal contraceptives, and clofibrate (and perhaps other lipid-lowering drugs)

10. Subjects who are receiving other liver support drugs (including drugs of the study), 1 month before study initiation.

11. Subjects with auto immune liver disease taking corticosteroid or immune suppressant

12. Pregnant or breast-feeding women

13. Use of oral contraceptives in child bearing ladies