Sponsor study identifier
interventional
360
1 country
6
Study Start
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The goal of this clinical trial is to compare the efficacy of L-ornithine L-aspartate and Polyethylene Glycol in Cirrhotic Patients with Overt Hepatic Encephalopathy. Participants will be asked to fill out a few questions on proforma that will obtain demographic information as well as information relating to the patient's health. Treatments that they will receive after inclusion in the study, will be the standard treatment (Lactulose) along with additional medication as part of our research (LOLA or Polyethylene glycol).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 16, 2023
Actual (reported)June 27, 2023
Actual (reported)October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Patient recovery among all groups through a change in mental state.
Change of at least one grade in the mental state based on the modified West Haven criteria and hepatic encephalopathy grading scale. A decrease in the grade will be a better outcome.
Change will be assessed at enrollment.
Patient recovery among all groups through a change in mental state.
A change of at least one grade in the mental state based on the modified West Haven criteria and hepatic encephalopathy grading scale. A decrease in the grade will be a better outcome.
Change will be assessed at 24 hours post enrollment.
Patient recovery among all groups through a change in mental state.
A change of at least one grade in the mental state based on the modified West Haven criteria and hepatic encephalopathy grading scale. A decrease in the grade will be a better outcome.
Lactulose which is the standard of care treatment will be administered with the experimental drug L-ornithine L-aspartate (LOLA).
Lactulose which is the standard of care treatment will be administered with the experimental drug polyethylene glycol (PEG).
Bolan Medical Complex Hospital
Quetta, Balochistan, Pakistan
Sheikh Khalifa bin Zayed
Quetta, Balochistan, Pakistan
Nishtar Medical Univeristy and Hospital
Multan, Punjab Province, Pakistan
First Submitted
June 16, 2023
First Posted
June 27, 2023
Study Start
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A change will be assessed at 48 hours post enrollment.
Patient recovery among all groups through a change in mental state.
A change of at least one grade in the mental state based on the modified West Haven criteria and hepatic encephalopathy grading scale. A decrease in the grade will be a better outcome.
A change will be assessed at 72 hours post enrollment.
Patient recovery among all groups through a change in mental state.
A change of at least one grade in the mental state based on the modified West Haven criteria and hepatic encephalopathy grading scale. A decrease in the grade will be a better outcome.
A change will be assessed at 96 hours post enrollment.
Patient recovery among all groups through a change in mental state.
A change of at least one grade in the mental state based on the modified West Haven criteria and hepatic encephalopathy grading scale. A decrease in the grade will be a better outcome.
A change will be assessed at 120 hours post enrollment.
Patient recovery among all groups through a change in mental state.
A change of at least one grade in the mental state based on the modified West Haven criteria and hepatic encephalopathy grading scale. A decrease in the grade will be a better outcome.
A change will be assessed at 144 hours post enrollment.
A change in Quality of Life will be assessed through SF-36
Quality of life will be assessed at 28th day post enrollment.
A change in Quality of Life will be assessed through SF-36
Quality of life will be assessed at 84th day post enrollment.
A change in mortality rate
it will be inquired at 7th day post enrollment.
A change in mortality rate
it will be inquired at 28th day post enrollment.
A change in mortality rate
it will be inquired at 84th day post enrollment.
This group will receive Lactulose only which is the standard of care treatment.
Contact the study team to confirm eligibility.
Sheikh Zayed Medical College/Hospital
Rahim Yar Khan, Punjab Province, Pakistan
Medical ICU, Jinnah Postgraduate Medical Centre
Karachi, Sindh, 71550, Pakistan
CMC hospital
Larkana, Sindh, Pakistan
Primary Completion
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 13, 2023
Record last verified: 2023-07
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