A study to see the effect of lactulose plus rifaximin versus lactulose plus rifaximin plus L Ornithine L Aspartate in treatment of brain dysfunction associated with chronic liver disease

A Double Blind Randomised Controlled trial comparing Lactulose plus Rifaximin with Lactulose plus Rifaximin plus L-Ornithine L- Aspartate in treatment of Overt Hepatic Encephalopathy(Grade III-Grade IV) in patients with cirrhosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/018966

Enrollment

124

Registered

2019-05-07

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: K740- Hepatic fibrosis

Interventions

Intervention1: Lactulose plus rifaximin plus L ornithine L Asoartate(LOLA) vs lactulose rifaximin and placebo: The patients will be randomized to receive either Group A or Group B. Both groups will re

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age of patients 18-70 years. 2. Hepatic cirrhosis based on clinical, biochemical, radiological and/or histological data 3. Patients with overt acute grade 3 and 4 HE, according to the West Haven criteria, with or without precipitating factors

Exclusion criteria

Exclusion criteria: 1.Acute on chronic liver failure 2.Hepatocellular carcinoma 3.Wilsonâ??s disease 4.Advanced cardiac or pulmonary disease 5.Neurologic disease (including head injury and drug intoxication) CNS active drugs. 6.Pregnancy or breast feeding 7.Cirrhotics with h/o HE already taking L-Ornithine â?? L â??Aspartate 8.Presence of underlying chronic renal failure (serum creatinine > 1.5mg/dl) 9.Psychiatric illness; patients who are on sedatives and antidepressants 10.Those who do not give informed consent

Design outcomes

Primary

Measure	Time frame
Reversal of HE or improvement of HE by 2 grades (according to West Havens Criteria) and mental state grade after 5 days of treatmentTimepoint: Reversal of HE or improvement of HE by 2 grades (according to West Havens Criteria) and mental state grade after 5 days of treatment	—

Secondary

Measure	Time frame
Blood Ammonia LevelsTimepoint: 5 days;Cause of DeathTimepoint: 28 days;Death due to other causesTimepoint: 28 days;Discontinuation due to adverse effectsTimepoint: 5 days;Length of hospital stayTimepoint: 28 days;Liver related deathTimepoint: 28 days;Mortality (time frame 4 weeks)Timepoint: 28 days;Rate of Recovery from HETimepoint: 5 days;Serum Cytokines levels (IL-1,IL-6,IL-10,TNF-alpha,S. Endotoxins)Timepoint: 5 days	—

Measure

Time frame

Blood Ammonia LevelsTimepoint: 5 days;Cause of DeathTimepoint: 28 days;Death due to other causesTimepoint: 28 days;Discontinuation due to adverse effectsTimepoint: 5 days;Length of hospital stayTimepoint: 28 days;Liver related deathTimepoint: 28 days;Mortality (time frame 4 weeks)Timepoint: 28 days;Rate of Recovery from HETimepoint: 5 days;Serum Cytokines levels (IL-1,IL-6,IL-10,TNF-alpha,S. Endotoxins)Timepoint: 5 days

—

Countries

India

Contacts

Public ContactDr Arpan Jain

G B Pant Hospital

barjeshchandershama@gmail.com7389529125

Outcome results

None listed

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