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Comparison of injectable L-Ornithine L -Aspartate versus oral L-Ornithine L -Aspartate for treatment of Cirrhosis patients with altered behavior.

Randomized comparative study to assess the efficacy of injectable L-Ornithine L -Aspartate versus oral L-Ornithine L -Aspartate for the treatment of overt hepatic encephalopathy in Cirrhosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029943
Enrollment
40
Registered
2020-12-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Health Condition 1: K742- Hepatic fibrosis with hepatic sclerosis

Interventions

Intervention1: drug by oral or intravenous route: in one group LOLA is given oral and in other group it is administered intravenously Control Intervention1: Injectable Lola Versus Oral Lola: Injectabl

Sponsors

BSBY Scheme Govt of Rajasthan
Lead Sponsor
Rajasthan Medicare Relief Society
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Cirrhosis 2. Age 18-75 years 3. Overt HE (Grade 2-4)

Exclusion criteria

Exclusion criteria: 1. Terminally ill patients 2. Advanced cardiac or pulmonary disease 3. Underlying chronic renal failure or acute kidney injury with serum creatinine > 1.5 mg/dl 4. Neurodegenerative disease or major psychiatric illness 5.Use of sedatives or antidepressants 6. Pregnancy or breast-feeding 7.HCC 8. ACLF

Design outcomes

Primary

MeasureTime frame
Mental State GradeTimepoint: 5 Days of Treatment—

Secondary

MeasureTime frame
1.Change in blood ammonia levels 2. Rate of recovery from HE 3. Length of hospital stay.Timepoint: 1.Change in blood ammonia levels at day five compared to day one. 2. Rate of recovery from HE 3. Length of hospital stay.—

Countries

India

Contacts

Public ContactRishabh Gupta

SMS Medical College Jaipur

drashokjhajharia@gmail.com9414236572

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026