NCT03448770

To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics.

To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

All patients presenting to the emergency department of Institute of Liver and Biliary Sciences with known cirrhosis and hepatic encephalopathy with grade II will be included in the study. The patient will be randomized into one of the two arms of lactulose or polyethylene glycol. The patient on the lactulose arm will be administered 20 to 30 g of lactulose orally or by nasogastric tube (3 or more doses within 24 hours ) or if oral intake was not possible or inadequate. The Dose will be repeated to ensure 3-4 loose motions per day. The Polyethylene Glycol group will get 17 gm of PEG (Polyethylene Glycol) administered orally or via nasogastric tube. PEG (Polyethylene Glycol)will be administered in 3-4 doses in 24 hours to ensure 3-4 loose stools per day.

Conditions

• Cirrhosis

Interventions

Type	Name	Description
DRUG	PEG- 17 gm sachet	PEG- 17 gm sachet 3-4 times per day
DRUG	Lactulose : 20-30gm	Lactulose : 20-30gm

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2018-02-28
• Last updated: 2018-02-28

Locations

1 site across 1 country: India