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Study of improvement in sleep quality in patients of cirrhosis of liver after therapy with lactulose

SLEEP DISTURBANCES IN PATIENTS OF 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/2015/01/005464
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 Minimal Hepatic encephalopathy

Interventions

Intervention1: Lactulose: Lactulose therapy will be given to 50 patients of cirrhosis with MHE for 3 months. Starting at a dose of 30ml 6 hourly and will be titrated accordingly to have a stool freque

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 (Na 150meq and K 5.5meq) at the time of evaluation - Evidence of Infection ( Fever,TLC >11000) at the time of enrolment -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
-Improvement in quality of sleep -Improvement or worsening in MHE. -Improvement in health related quality of life. Timepoint: -Improvement in quality of sleep -Improvement or worsening in MHE. -Improvement in health related quality of life.

Secondary

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

Countries

India

Contacts

Public ContactDr BC Sharma

Delhi University

drbcsharma@hotmail.com9718599203

Outcome results

None listed

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