NCT03161106

To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis.

To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis- A Randomised Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The study will be conducted on patients attending /admitted to Department of Hepatology from April 2017 to December 2018 at ILBS, New Delhi . Clinical, anthropometric and biochemical assessment will be done by candidate, co-supervisors and supervisor. Patients in treatment group will receive nutritional therapy in the form of 30-kcal/kg/day and 1.5gm/kg/day protein with supplements. Other patients will continue diet that they were receiving before along with lactulose. Previous treatment and prophylaxis of variceal bleed any (endoscopic variceal ligation or beta blocker) will be continued as before. All subjects will be followed up every month for treatment compliance and for development of any complications.

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutrition	Nutrional group-30 kcal/kg with 1.5 grm protein with protein supplements
DRUG	Lactulose	Lactulose plus diet consumed by patient
DIETARY_SUPPLEMENT	Diet	Protein Powder 15 to 20 gm/meal/day

Timeline

• Start date: 2017-05-15
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2017-05-19
• Last updated: 2018-12-11

Locations

1 site across 1 country: India