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All patients presenting to the emergency department of Institute of Liver and Biliary Sciences with known cirrhosis and hepatic encephalopathy with grade II will be included in the study. The patient will be randomized into one of the two arms of lactulose or polyethylene glycol. The patient on the lactulose arm will be administered 20 to 30 g of lactulose orally or by nasogastric tube (3 or more doses within 24 hours ) or if oral intake was not possible or inadequate. The Dose will be repeated to ensure 3-4 loose motions per day. The Polyethylene Glycol group will get 17 gm of PEG (Polyethylene Glycol) administered orally or via nasogastric tube. PEG (Polyethylene Glycol)will be administered in 3-4 doses in 24 hours to ensure 3-4 loose stools per day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactulsoe | Active Comparator | Lactulose : 20-30gm 2-3 doses per day |
|
| Polyethlene Glycol | Experimental | PEG (Polyethlene Glycol)- 17 gm sachet 3-4 times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG- 17 gm sachet | Drug | PEG- 17 gm sachet 3-4 times per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Complete reversal of hepatic encephalopathy in both groups. | Complete reversal is defined as Grade 0 Encephalopathy | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in hepatic encephalopathy by two grades in both groups | 3 days | |
| Length of Intensive Care Unit stay in both groups | 28 days | |
| Adverse events in both groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Abhinav Verma, MD | Contact | 01146300000 | abhinav.3183@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of liver and Biliary Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Lactulose : 20-30gm |
| Drug |
Lactulose : 20-30gm |
|
| 3 days |
| Presence of encephalopathy changes in Electroencephalography in both groups | 3 days |