| CTRI Number |
CTRI/2023/09/057449 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
31/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of the drug L Ornithine L Aspartate (LOLA) in liver disease |
|
Scientific Title of Study
|
A prospective, observational add on study to evaluate the effect of L Ornithine L
Aspartate (LOLA) on clinical outcomes in overt hepatic encephalopathy patients on lactulose and rifaximin vs
rifaximin and lactulose |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saheli Das |
| Designation |
DM Resident |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Clinical Pharmacology and Therapeutics,OPD Block,2nd floor,Punjagutta,Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9435870295 |
| Fax |
|
| Email |
sahelidas037@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhakar Reddy |
| Designation |
Additional Professor |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Clinical Pharmacology and Therapeutics,OPD Block,2nd floor,Punjagutta,Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9435870295 |
| Fax |
|
| Email |
cptnims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saheli Das |
| Designation |
DM Resident |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Clinical Pharmacology and Therapeutics,OPD Block,2nd floor,Punjagutta,Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9435870295 |
| Fax |
|
| Email |
sahelidas037@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Saheli Das |
| Address |
Department of Clinical Pharmacology and Therapeutics,OPD Block,2nd floor,Punjagutta,Hyderabad |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
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 Saheli Das |
Nizams Institute of Medical Sciences |
Department of Medical Gastroenterology,Millenium Block,3rd floor,Punjagutta
Hyderabad
TELANGANA |
9435870295
sahelidas037@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K769||Liver disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Rifaximin
Syrup Lactulose
Inj L Ornithine L Aspartate |
Rifaximin 55o mg BD for 1 week
Syrup Lactulose 30 ml OD for 1 week
Inj L Ornithine L aspartate 20-30g over 2-3 hrs for 3-7 days
|
| Comparator Agent |
Tab Rifaximin
Syrup Lactulose |
Rifaximin 55o mg BD for 1 week
Syrup Lactulose 30 ML OD for 1 week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)In-Patients diagnosed of Overt Hepatic Encephalopathy (Grade 2 or more) according to
West Haven’s criteria who are on lactulose and rifaximin
2)Subjects/ LARs willing to comply with the study procedures and willing to give written
informed consent
3) Patients should be capable to comprehend letters and numbers |
|
| ExclusionCriteria |
| Details |
1)Pregnant and lactating women
2) History of hypersensitivity to any drug or the study drug
3) History of intake of any drugs that may interfere with CNS activity
4) Subjects with pre existing medical conditions like cardiac , pulmonary or neurological
disease/psychiatric disorder which in the judgement of the clinician would interfere with
the study
5) Serum creatinine > 3 mg/dl |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the change in neurological status by West Haven scoring at the end of 1
week from the baseline |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine change in fasting serum ammonia at the end of 1 week from the baseline
visit
2. To compare the psychometric test parameters (NCT A ,NCT B, DLST) between both the
groups at the end of 1 week of treatment.
3.To compare the QoL between both the groups using SF-36 Questionnaire at the end of 1
week of treatment.
4.To compare the occurrence of adverse effects |
1 week |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hepatic encephalopathy (HE) is a reversible syndrome of impaired brain function occurring in patients with advanced liver disease. These patients may present initially with sleep-wake cycle disturbance, personality changes and cognitive, motor activity and coordination dysfunctions, which will eventually progress to stupor, coma and death. It also affects the quality of life and patient survival. Data on the use of intravenous L-ornithine L-aspartate (LOLA) in the treatment of overt HE (OHE) is limited. In this study LOLA, a branched chain amino acid will be investigated for reversing the clinical symptoms in hepatic encephalopathy patients. A sample size of 53 was calculated . Considering unequal group sizes, 19 patients will be included in Group I and 34 in Group II (roughly 1:2 ratio) Group I – Subjects will receive iv LOLA (20-30 g over 2-3 hrs ) for 3- 7days + standard background therapy Group II - Subjects will receive only standard background therapy Standard background therapy- All the patients will be receiving Syrup lactulose 30 ml OD and Tab Rifaximin 550 mg BD throughout the study for 1 week . |