A clinical trial for Evaluating the Effectiveness of a New Nano Formulation vs. Standard conventional formulation of Ursodeoxycholic Acid for Treating Liver Disease.

A prospective, randomized, assessor blinded, two arm, comparative, Phase IV, single center, investigator initiated clinical study to assess the impact of nano formulation of ursodeoxycholic acid as compared to conventional formulation of ursodeoxycholic acid on liver markers in patients with liver diseases. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075231

Enrollment

100

Registered

2024-10-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: K768- Other specified diseases of liver

Interventions

Intervention1: Ulyses 300 tablets: One tablet twice daily for 28 days Control Intervention1: ursodeoxycholic acid 300 (Generic) tablets: One tablet twice daily for 28 Days

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either gender between 18-65 years of age (both inclusive) 2. Patients with established diagnosis of NAFLD, drug induced hepatitis, acute viral hepatitis, alcoholic hepatitis 3. Patients with elevated liver enzymes (at least 2 times upper limit of normal) requiring treatment with UDCA 4. Patients willing to provide written informed consent and comply with the protocol requirements

Exclusion criteria

Exclusion criteria: 1.Patients who have used UDCA in last three months 2.Patients with recurrent variceal bleeding, spontaneous portosystemic encephalopathy, diuretic-resistant ascites, bacterial peritonitis or anticipated need for transplantation within 1 year 3.Patients using any other prescribed or over the counter medication affecting liver function at screening 4.Patients with known hypersensitivity to the study drug 5.Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 6.Participation in another clinical trial within 3 months prior to screening 7.Patients with renal dysfunction (creatinine more than 1.5 of ULN) at screening 8.Patients with any other clinically significant cardiac, endocrine, pulmonary, gastrointestinal or neurological disorder 9.Participation in another clinical trial within 3 months prior to screening 10.Any other reason for which the investigator feels that the patient should not participate

Design outcomes

Primary

Measure	Time frame
Percentage change in AST levelsTimepoint: Baseline(Day 0) Vs Day 28	—

Secondary

Measure	Time frame
Percentage change in ALT, ALP, GGT and bilirubin levelsTimepoint: Baseline(Day 0) Vs Day 7,14,21,28;Percentage change in AST levelTimepoint: Baseline(Day 0) Vs Day 7,14,21;Proportion of patients achieving normal AST, ALT GGT and bilirubin levelsTimepoint: at 7 days, 14 days, 21 days and 28 days;Adverse events reported during the studyTimepoint: Basline (Day 0) to End of study;Serious adverse events reported during the studyTimepoint: Basline (Day 0) to End of study	—

Measure

Time frame

Percentage change in ALT, ALP, GGT and bilirubin levelsTimepoint: Baseline(Day 0) Vs Day 7,14,21,28;Percentage change in AST levelTimepoint: Baseline(Day 0) Vs Day 7,14,21;Proportion of patients achieving normal AST, ALT GGT and bilirubin levelsTimepoint: at 7 days, 14 days, 21 days and 28 days;Adverse events reported during the studyTimepoint: Basline (Day 0) to End of study;Serious adverse events reported during the studyTimepoint: Basline (Day 0) to End of study

—

Countries

India

Contacts

Public ContactDr Jayesh Sanmukhani

Clinexcel Research

drjayesh@clinexcelresearch.com7600012192

Outcome results

None listed

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