Clinical trail of NRL/2019/NL in Liver Disorder Patients with Abnormal Liver Function Test

Evaluation of efficacy and safety of NRL/2019/NL in Liver Disorder Patients with Abnormal Liver Function Test (LFT) A randomized, parallel arm, interventional, prospective clinical study. - NIL

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/01/023033

Enrollment

100

Registered

2020-01-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K769- Liver disease, unspecified

Interventions

Intervention1: NRL/2019/NL capsule 1BD after meals for 90 days: Marketed Formulation 1 BD Tablet after meals for 90 days Intervention2: NRL/2019/NL: NRL/2019/NL capsule 1 BD after meals for 90 days Co

Eligibility

Inclusion criteria

Inclusion criteria: Males or females 18-65 years of age Diagnosis of hepatic disorder with abnormal LFT 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 Subjects with or without fatty liver changes observed in Ultrasonography of abdomen will be enrolled in the study Serum total bilirubin level less than or equal to 2 mg/dl, or AST or ALT 2 times than normal values Subjects willing to sign inform consent form

Exclusion criteria

Exclusion criteria: Evidence of chronic viral hepatitis (Hepatitis B or C) and Biliary obstruction Previous entry into the study, or use of either prednisolone or PTX within 6 weeks of admission AST >500 U/L or ALT >300 U/L Suspected hypersensitivity to contents of study drug Advanced liver disease, subjects with serious illness History of gastritis, peptic ulcer, bleeding ulcer Patients with a renal failure Pregnant or lactating women Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrollment

Design outcomes

Primary

Measure	Time frame
Serum AST and ALT Serum total bilirubinTimepoint: Screening day,Day 30,60,90	—

Secondary

Measure	Time frame
Changes in USG Changes in serum status for SOD and CAT Changes in severity of symptoms of liver disease like anorexia, fatigue, abdominal pain, nausea etc. Changes in anthropometric parameters Assessment of Quality of Tolerability of study drugs Adverse drug reactions Vitals like pulse, body temperature, rate of respiration. Changes in biochemical parameters like, CBC, KFT, Lipid profile and Urine routine. Timepoint: Screening day,Baseline Day,Day30,60,90	—

Measure

Time frame

Changes in USG Changes in serum status for SOD and CAT Changes in severity of symptoms of liver disease like anorexia, fatigue, abdominal pain, nausea etc. Changes in anthropometric parameters Assessment of Quality of Tolerability of study drugs Adverse drug reactions Vitals like pulse, body temperature, rate of respiration. Changes in biochemical parameters like, CBC, KFT, Lipid profile and Urine routine. Timepoint: Screening day,Baseline Day,Day30,60,90

—

Countries

India

Contacts

Public ContactDr Omkar Kulkarni

Netsurf Research Labs Pvt Ltd

omkar.kulkarni@nrl.net.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026