Hepatic Encephalopathy Clinical Trial
Official title:
Effect of Vegetarian Versus Non Vegetarian Based Diet in the Recurrence of Hepatic Encephalopathy in Patients With Cirrhosis:An Open Label Study
Earlier protein restriction was advocated in the treatment of HE but later this concept was refuted and increase protein intake was advocated in patients with HE. Diet in patients during an episode HE is also not known. It is advisable based on many case reports or case series that vegetable-based diet during the episode of HE is better than animal-based diet as it reduces ammonia level and other false neurotransmitters in brain and helps in early recovery of, HE . However, diet in patients who had recovered from an episode of, HE is not known and what type of protein (vegetarian or non-vegetarian) should be taken to prevent another episode of HE has never been evaluated. In India majority of the patients are vegetarian and patients with cirrhosis are malnourished and lack protein in their diet as per our previous published study
Status | Recruiting |
Enrollment | 40 |
Est. completion date | October 16, 2024 |
Est. primary completion date | April 16, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 1) Age 18 years and older. 2) Confirmed diagnosis of liver cirrhosis. (Diagnosed on the basis of clinical, biochemical, radiological or endoscopic features). 3) Willingness to sign informed consent proforma. 4) Patients who recovered from Hepatic encephalopathy will be enrolled from Out patient Department within 15 days of discharge Exclusion Criteria: - 1) Patients with underlying severe cardiopulmonary disease or hepatocellular carcinoma. 2) Patients with CTP score of more than 12 3) Patient not willing for follow up or consent to participate in the study |
Country | Name | City | State |
---|---|---|---|
India | Sir Ganga Ram Hospital | Delhi |
Lead Sponsor | Collaborator |
---|---|
Sir Ganga Ram Hospital |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence of overt hepatic encephalopathy | 6 month follow up | ||
Secondary | Hospitalization due to any cause | six month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01559519 -
Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy
|
Phase 4 | |
Terminated |
NCT01846806 -
The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy.
|
N/A | |
Recruiting |
NCT01178372 -
Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis
|
Phase 4 | |
Completed |
NCT00914056 -
A Study of Controlled Lactulose Withdrawal
|
N/A | |
Completed |
NCT00740142 -
Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy
|
Phase 4 | |
Completed |
NCT00558038 -
Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy
|
Phase 2 | |
Completed |
NCT00986895 -
A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group
|
Phase 1 | |
Completed |
NCT00287235 -
Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)
|
N/A | |
Recruiting |
NCT05539027 -
Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy
|
Phase 4 | |
Recruiting |
NCT04096014 -
Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
|
N/A | |
Completed |
NCT05526404 -
Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration
|
N/A | |
Completed |
NCT04082780 -
Rifamycin in Minimal Hepatic Encephalopathy
|
Phase 2 | |
Enrolling by invitation |
NCT06367127 -
Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening
|
||
Active, not recruiting |
NCT05425316 -
Speech in Hepatic Encephalopathy (HE)
|
||
Recruiting |
NCT04415294 -
Flicker App for Minimal Hepatic Encephalopathy
|
||
Not yet recruiting |
NCT06072521 -
Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy
|
Phase 2 | |
Withdrawn |
NCT02086825 -
A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure
|
Phase 3 | |
Completed |
NCT02636647 -
Fecal Transplant in Recurrent Hepatic Encephalopathy
|
Phase 1 | |
Completed |
NCT01446523 -
S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE
|
N/A | |
Completed |
NCT01218568 -
Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
|
N/A |