Efficacy of L-Ornithine L-Aspartate and Polyethylene Glycol in Cirrhotic Patients With Overt Hepa… (NCT05920213) | Clinical Trial Compass
UnknownPhase 4
Efficacy of L-Ornithine L-Aspartate and Polyethylene Glycol in Cirrhotic Patients With Overt Hepatic Encephalopathy
Pakistan360 participantsStarted 2023-10
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Admitted cirrhotic patients above 18 years of age,
* diagnosed on clinical/ultrasound findings with HE (grade 2 or above) with or without precipitating factors.
Exclusion Criteria:
* Patients with hepatocellular carcinoma
* severe septicemia,
* active upper gastrointestinal bleeding and in a state of shock
* presence of underlying chronic renal failure (serum creatinine \>1.5 mg/dl)
* presence of hepatorenal syndrome
* neurodegenerative disease
* patients with a head injury and drug intoxication
* acute superimposed liver injury
* advanced cardiac or pulmonary derangements
* end-stage renal disease
* pregnant or breastfeeding mothers
* patients who are on sedatives, antidepressants, or benzodiazepines
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient recovery among all groups through a change in mental state.
Timeframe: Change will be assessed at enrollment.
2
Patient recovery among all groups through a change in mental state.
Timeframe: Change will be assessed at 24 hours post enrollment.
3
Patient recovery among all groups through a change in mental state.
Timeframe: A change will be assessed at 48 hours post enrollment.
4
Patient recovery among all groups through a change in mental state.
Timeframe: A change will be assessed at 72 hours post enrollment.
5
Patient recovery among all groups through a change in mental state.
Timeframe: A change will be assessed at 96 hours post enrollment.
6
Patient recovery among all groups through a change in mental state.
Timeframe: A change will be assessed at 120 hours post enrollment.
7
Patient recovery among all groups through a change in mental state.