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To study the effect of lactulose on sleep pattern in patients of cirrhosis of liver

Spectral electroencephalogram analysis in liver cirrhosis with minimal hepatic encephalopathy before and after lactulose therapy

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/01/005463
Enrollment
100
Registered
2015-01-27
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: null- Cirrhosis with and without minimal Hepatic encephalopathy

Interventions

Intervention1: Lactulose: 30 ml lactulose will be given orally three times a day and titrated to have 2-3 semisolid stools per day, for 3 months Control Intervention1: Nil: Nil

Sponsors

GB Pant Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of Cirrhosis with and without MHE

Exclusion criteria

Exclusion criteria: -Overt HE or history of overt HE - History of shunt surgery or transjuglar intrahepatic portosystemic shunt for portal hypertension -Electrolyte imbalance - Evidence of infection at the time of enrollment -History of recent use (within one month) of drugs affecting psychometric performances like benzodiazepines, antiepileptics, or psychotropic drugs - Hepatocellular carcinoma - Severe medical problems such as congestive heart failure, pulmonary disease, or neurological or psychiatric disorder that could influence quality-of-life measurement; and inability to perform neuropsychological tests . - History of alcohol intake within last one month. - History of intake of lactulose,rifaximin, L-ornithine-L-aspartate or probiotics in last one month. - History of GI bleed in last one month, spontaneous bacterial peritonitis (SBP) on prophylaxis or hepatorenal syndrome (HRS). - Patients of acute on chronic liver failure (ACLF).

Design outcomes

Primary

MeasureTime frame
Changes in Spectral EEG after Lactulose therapy. -Improvement in MHE after after Lactulose therapy Timepoint: Changes in Spectral EEG after 3 months of Lactulose therapy. -Improvement in MHE after after Lactulose therapy

Secondary

MeasureTime frame
--Improvement in CTP and MELD score. -Hospital admission -Mortality Timepoint: 3 months

Countries

India

Contacts

Public ContactJatinderpal singh

GB Pant Hospital

drbcsharma@hotmail.com9718599203

Outcome results

None listed

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