A Trial for Comparing Rifaximin, Probiotic and L-ornithine- L Aspartate With Lactulose in Overt H… (NCT07037394) | Clinical Trial Compass
CompletedPhase 4
A Trial for Comparing Rifaximin, Probiotic and L-ornithine- L Aspartate With Lactulose in Overt Hepatic Encephalopathy.
Pakistan252 participantsStarted 2024-12-02
Plain-language summary
The goal of this trial is to learn if drugs in group A, B, C and D works to treat reversal of grades in people with overt hepatic encephalopathy. It will also provide information regarding safety of drugs in group A, B, C and D. The main question it aim to answer is:
Which study group is better in treating people of overt hepatic encephalopathy. Researchers will compare experimental group B (rifaximin + lactulose), group C (probiotics + lactulose) and group D (LOLA (L-Ornithine L-Aspartate) + lactulose) to control group A lactulose alone in the reversal of grades for people of hepatic encephalopathy.
Participants will:
Take drug from time of participation in the trial till the end of treatment (day 5) and grade reversal will be observed.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Both male and female participants with age \>18 to \<80 years old at the time of consent.
✓. Patients with decompensated chronic liver disease (DCLD) confirmed by ultrasound, endoscopy or blood tests associated with overt hepatic encephalopathy grade II-IV according to West Haven Criteria (WHC) will be included.
✓. Patients who are unable to talk, their informed consent will be collected from first degree relative and/or legally authorized representative (LAR).
✓. The subject/LAR has signed the consent/assent form authorized by the ethics committee, is willing to follow the treatment protocol, and has been informed of the purpose of the study.
Exclusion criteria
✕. Participants with age ≤18 years old and ≥ 80 years old and those with grade1covert hepatic encephalopathy according to West Haven Criteria.
✕. Patients with comorbidities including ventricular dysfunction and pulmonary edema or neurodegenerative disease (Epilepsy, Parkinson and Drug intoxication), hepatocellular carcinoma (HCC) and with major psychiatric illness (Schizophrenia).
✕. Patients with presenting complaint of diarrhea will be excluded.
What they're measuring
1
Number of participants of overt hepatic encephalopathy are treated by observing reversal in grades by using West Haven Criteria.
Timeframe: From the time of enrollment till the end of treatment (day 5) in the trial.
✕. Recent or current use of sedatives or antidepressants and those who are suffering from encephalitis (viral or bacterial), Wernicke and uremic encephalopathy, stroke or brain tumor will not be included.
✕. The participant is already participating in another drug trial.
✕. Pregnant women will not be included.
✕. Subjects suffering from terminal cancers or HIV-AIDS.
✕. Participants hypersensitive to lactulose, rifaximin, LOLA and probiotics or any of its excipients will be excluded.