Effectiveness Of Oral Lactulose Versus Lactulose Enema On The Time To Recovery From Overt Hepatic Encephalopathy
Status: Unknown
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Patients with chronic liver disease due to hepatitis B or C viruses, Non-alcoholic fatty liver disease, autoimmune hepatitis, wilson disease, cryptogenic hepatitis etc are prone to develop complications. Hepatic encephalopathy is one of such complications. It is graded into four types depending on severity of clinical features, which range through altered sleep pattern to coma. The current study aims to compare the effectiveness of lactulose enema with oral lactulose in time to recovery from higher grade of encephalopathy to lower grade of encephalopathy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male and female cirrhotic patients in grades 3 or 4 of hepatic encephalopathy
• Patient with constipation as the precipitating factor will be included in the study
Contact Information
Primary
Aliena Badshah
aliena.badshah@kmc.edu.pk
0092-335-5950615
Time Frame
Start Date: 2023-04
Completion Date: 2023-11
Participants
Target number of participants: 100
Treatments
Placebo_comparator: Placebo arm / tap water enema arm
This arm will receive oral lactulose as per treatment protocol for hepatic encephalopathy i.e. 30ml twice daily. And will receive tap water enema as placebo i.e. 1000ml tap water enema twice daily.
Experimental: Lactulose enema arm
This arm will receive oral lactulose in a dose of 30ml twice daily alongwith lactulose enema (300ml lactulose plus 700ml water) twice daily.
Related Therapeutic Areas
Sponsors
Leads: Khyber Medical College, Peshawar