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

Phase 3

• Conditions: Health Condition 1: null- Cirrhosis with Minimal Hepatic encephalopathy

• Registration Number: CTRI/2015/01/005464
• Lead Sponsor: GB Pant Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Patients of Cirrhosis with and without MHE

Exclusion Criteria

-Overt HE or history of overt HE

- History of shunt surgery or transjuglar intrahepatic portosystemic shunt for portal hypertension

-Electrolyte imbalance (Na <120 or >150meq and K <3.5 or >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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified