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Efficacy of L-ornithine L-aspartate ( LOLA) on Overt Hepatic Encephalopathy and Neuroinflammation

Efficacy of L-ornithine L-aspartate ( LOLA) in combination with Lactulose and Rifaximin in Patients with Cirrhosis on Recovery of Overt Hepatic Encephalopathy and Modulation of Systemic and Neuroinflammation: A Randomized, Placebo- controlled, Double Blind Investigator Initiated Trial . - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106404
Enrollment
140
Registered
2026-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: K721- Chronic hepatic failure

Interventions

Intervention1: LOLA- L-ornithine L-Aspartate + Lactulose + Rifaximin: Arms: o Arm A: Lactulose + Rifaximin + LOLA o Arm B: Lactulose + Rifaximin + Placebo Intervention Duration: Treatment will be

Sponsors

WINMEDICARE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A Diagnosis of cirrhosis based on clinical, biochemical, radiological, and/or histology with overt grade III IV Hepatic Encephalopathy, according to the West Haven criteria. Signed informed consent

Exclusion criteria

Exclusion criteria: Acute on chronic liver failure Hepatocellular carcinoma Wilson s disease Advanced cardiac or pulmonary disease Neurologic disease (including head injury and drug intoxication) CNS active drugs

Design outcomes

Primary

MeasureTime frame
Primary Outcome: Proportion and rate of recovery from HE. Timepoint: 10 days or death whichever occurs first—

Secondary

MeasureTime frame
1. Mortality rate 2. Adverse effects 3. Proportion of patients developing organ failure other than cerebral failure 4. Change in inflammatory markers in serum & CSF Timepoint: 10 days or death whichsoever occurs first—

Countries

India

Contacts

Public ContactB C Sharma

ABVIMS and Dr RML Hospital

drbcsharma@hotmail.com9540951000

Outcome results

None listed

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