Assessment of reversal in grades of overt hepatic encephalopathy by comparing the efficacy of rifaximin, probiotic and L-ornithine- L aspartate with lactulose as control drug for clinical trial.

Comparison of efficacy of rifaximin, probiotic and L-ornithine- L aspartate with outcome of reversal in grades of overt hepatic encephalopathy : A randomized, phase IV, lactulose controlled clinical trial. - COPE-RPLL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300075925

Enrollment

Unknown

Registered

2023-09-19

Start date

2023-10-05

Completion date

Unknown

Last updated

2023-09-26

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

Conditions

Hepatic Encephalopathy

Interventions

A:LACTULOSE

B:RIFAXIMIN + LACTULOSE

C:PROBIOTIC + LACTULOSE

D:(L-Ornithine L- Aspartate) LOLA + LACTULOSE

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Both male and female participants with age > 18 years old. Patients diagnosed with Chronic liver disease (CLD) and Decompensated Chronic liver disease (DCLD) having overt hepatic encephalopathy grade II-IV. (West Haven Criteria will be included).

Exclusion criteria

Exclusion criteria: Participants with age < 18 years old having advanced cardiac or pulmonary diseases or neurodegenerative disease (including head injury and drug intoxication) and with major psychiatric illness. Patients using sedatives or antidepressants and suffering from viral or bacterial encephalitis, stroke, brain tumor, Wernicke’s encephalopathy will not be included.

Design outcomes

Primary

Measure	Time frame
reversal in grades of hepatic encephalopathy;	—

Countries

Pakistan

Contacts

Public ContactDr. Qurratul Ain Jamil

Department of Pharmacy Practice

qurratulainjamilrana@gmail.com+92 317 4280805

Outcome results

None listed

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