To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis.
NCT03161106 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2018-12-11
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
Interventions
- 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
Sponsors & Collaborators
-
Institute of Liver and Biliary Sciences, India
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-15
- Primary Completion
- 2018-10-01
- Completion
- 2018-10-01
Countries
- India
Study Locations
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