| CTRI Number |
CTRI/2014/08/004836 [Registered on: 07/08/2014] Trial Registered Prospectively |
| Last Modified On: |
06/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
L-Ornithine L-Aspartate for prevention of hepatic encephalopathy |
|
Scientific Title of Study
|
Secondary Prophylaxis of hepatic encephalopathy in cirrhosis:A double Blind randomized controlled trial of L-Ornithine L-Aspartate (LOLA) versus placebo |
| Trial Acronym |
LOLA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B C Sharma |
| Designation |
Professor |
| Affiliation |
G B Pant Hospital, New Delhi |
| Address |
Room no 203, Academic Block,
Deptt of Gastroenterology,
G B Pant Hospital, New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
drbcsharma@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B C Sharma |
| Designation |
Professor |
| Affiliation |
G B Pant Hospital, New Delhi |
| Address |
Room no 203, Academic Block,
Deptt of Gastroenterology,
G B Pant Hospital, New Delhi
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
drbcsharma@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B C Sharma |
| Designation |
Professor |
| Affiliation |
G B Pant Hospital, New Delhi |
| Address |
Room no 203, Academic Block,
Deptt of Gastroenterology,
G B Pant Hospital, New Delhi
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
drbcsharma@hotmail.com |
|
|
Source of Monetary or Material Support
|
| G B Pant Hospital, New Delhi with drug support from Primary Sponsor |
|
|
Primary Sponsor
|
| Name |
Win Medicare Pvt Ltd |
| Address |
1400, Modi tower,
98, Nehru Place,
New Delhi- 110019 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr B C Sharma |
G B Pant Hospital |
Department of Gastroenterology,
G B Pant Hospital,
1, JLN Marg,
New Delhi
Central
DELHI |
9718599203
drbcsharma@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College and associated Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cirrhotics with Hepatic Encephalopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
L-Ornithine L-Aspartate (LOLA) |
L-Ornithine L-Aspartate (LOLA)
6 grams three times a day by oral route for six months
will be given in cirrhotic patients of Hepatic Encephalopathy |
| Comparator Agent |
Placebo (Drug granules without active compound of L-ornithine L-aspartate) |
Placebo(Drug granules without active compound of L-ornithine L-aspartate) 6 grams three times a day by oral route for six months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
•Liver cirrhosis (Child B or Child C class)
•History of recovery from episod of overt hepatic encephalopathy (West-Haven grade 1 and above) in last 12 months.
•No evidence of overt hepatic encephalopathy at the time of enrollment
|
|
| ExclusionCriteria |
| Details |
•History of taking lactulose, rifaximin, neomycin, metronidazole, HepaMerz or probiotics in past 6 weeks
•Alcohol intake during past 6 weeks
•Receiving secondary prophylaxis for spontaneous bacterial peritonitis
•Previous transjugular intrahepatic portosystemic shunts or shunt surgery
•Significant comorbid illness such as heart, respiratory or kidney failure, and neurological disease such as Alzheimer’s disease, Parkinson’s disease and non hepatic metabolic encephalopathies
•Receiving psychoactive drugs such as antidepressants and sedatives
•Foreseeable risk of alcohol consumption during the study conduct.
•Hepatocellular carcinoma
•Anemia (Hemoglobin <8gm/dL)
•Electrolyte abnormality (Serum sodium <125meq/L or serum potassium <2.5meq/L)
•Intercurrent infection such as spontaneous bacterial peritonitis
•Pregnancy, breast feeding or refusal to use a contraceptive method in women of child bearing age
•Patients with foreseeable compliance <80% during study conduct monitored by counting sachets of Hepa-Merz and bottles of lactulose consumed every month.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Superiority of L-Ornithine L-Aspartate compared to placebo in the efficacy of prevention of overt HE recurrence. |
one week to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Time taken for first breakthrough episode of overt hepatic encephalopathy
•Time to first overt hepatic encephalopathy-related hospital admission
|
one week to 3 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/09/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hepatic encephalopathy is a
neuropsychiatric disorder caused by central nervous system effect of the toxins
that accumulate in the blood because of the inability of liver to perform its
normal detoxification functions. Treatment of HE cost alot to the hospital and
has got a high mortality rate. Gut-derived nitrogenous substances are
universally acknowledged to play a major role in the pathogenesis of hepatic
encephalopathy. Ammonia- induced alterations
in cerebral blood flow and glucose metabolism have shown that there is a
significant decrease of glucose utilization of various cortical regions that
correlate with the patients cognitive functions. L-Ornithine L-Aspartate (LOLA) act by reducing blood ammonia level
and reducing symptoms in patients of HE. But data regarding it’s use in
prophylaxis of HE is scarce. We hypothesise that L -Ornithine L-Aspartate (LOLA) by reducing
blood ammonia level in cirrhotics may be useful in secondary prophylaxis of
hepatic encephalopathy.
|