Clinical Study on â??SHL 1055â?? Tablet in Liver Disorder.

Phase 2

• Conditions: Health Condition 1: K77- Liver disorders in diseases classified elsewhere

• Registration Number: CTRI/2018/04/013034
• Lead Sponsor: SAVESTA LIFESCIENCES INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1). Diagnosis of hepatic disorder with abnormal LFT (Serum total bilirubin level greater than or equal to 2 mg/dl, or AST or ALT greater than 2 times ULN) with or without signs and symptoms such as dark-colored urine, light-colored stools, pruritus, pruritic red hives, fever, nausea, vomiting, anorexia, and right upper abdominal discomfort, pain or feeling of pressure

2).Subjects with abnormal LFT (Serum total bilirubin level greater than or equal 2 mg/dl, or AST or ALT greater than 2 times ULN) with or without fatty liver changes observed in Ultrasonography of abdomen will be enrolled in the study.

3).Serum total bilirubin level greater than or equal 2 mg/dl, or AST or ALT greater than 2 times ULN

4).A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period

5).Subjects willing to practice effective method of contraception during study period

6).Subjects willing to sign inform consent form

Exclusion Criteria

1)Duration of clinically apparent jaundice greater than 3 months

2)Other causes of liver disease including evidence of chronic viral hepatitis (Hepatitis

B or C) and Biliary obstruction

3)Previous entry into the study, or use of either prednisolone or PTX within 6 weeks of admission

4)AST greater than 500 U/L or ALT greater than 300 U/L

5)Suspected hypersensitivity to contents of study drug

6)Advanced liver disease (e.g. ascites, bleeding esophageal varices and hepatic encephalopathy, hepatic cancer)

7)Subjects with serious illness, e.g., uncontrolled diabetes, multisystem failure, HIV, cancer, severe renal insufficiency, serious cardiovascular disease and patients with history of gastritis, peptic ulcer, bleeding ulcer

8)Patients with a renal failure

9)Pregnant or lactating women

10)Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrollment or could interfere with his/her participation in, and completion of the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage change in the AST and ALT level from baseline to end of therapyTimepoint: Screening Visit (up to -14 day), Baseline Visit (Day 0), Visit 1 (Day 15), Visit 2 (Day 30), Visit 3 (Day 45), Visit 4 (Day 60) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Percentage change in the AST and ALT level <br/ ><br>2.Percentage change in the serum total bilirubin level <br/ ><br>3.Percentage change in subjective clinical signs and symptoms <br/ ><br>4.Assessment of global evaluation for overall improvement by physician and subject <br/ ><br>5.Assessment of tolerability of study drug by assessing adverse events <br/ ><br>6.Assessment of lab parameters and vitals <br/ ><br>Timepoint: Screening Visit (up to -14 day), Baseline Visit (Day 0), Visit 1 (Day 15), Visit 2 (Day 30), Visit 3 (Day 45), Visit 4 (Day 60) <br/ ><br>