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CTRI Number  CTRI/2019/05/018966 [Registered on: 07/05/2019] Trial Registered Prospectively
Last Modified On: 06/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to see the effect of lactulose plus rifaximin versus lactulose plus rifaximin plus L Ornithine L Aspartate in treatment of brain dysfunction associated with chronic liver disease 
Scientific Title of Study   A Double Blind Randomised Controlled trial comparing Lactulose plus Rifaximin with Lactulose plus Rifaximin plus L-Ornithine L- Aspartate in treatment of Overt Hepatic Encephalopathy(Grade III-Grade IV) in patients with cirrhosis 
Trial Acronym   
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  Director Professor 
Affiliation  G B Pant Hospital 
Address  Department of Gastroenterology 2nd Floor Academic Block GB Pant Hospital 1,Jawaharlal Nehru Marg New Delhi 110002

Central
DELHI
110002
India 
Phone  7389529125  
Fax    
Email  barjeshchandershama@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr B C Sharma 
Designation  Director Professor 
Affiliation  G B Pant Hospital 
Address  Department of Gastroenterology 2nd Floor Academic Block GB Pant Hospital 1,Jawaharlal Nehru Marg New Delhi 110002

Central
DELHI
110002
India 
Phone  7389529125  
Fax    
Email  barjeshchandershama@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arpan Jain 
Designation  Senior Resident DM 
Affiliation  G B Pant Hospital 
Address  Department of Gastroenterology 2nd Floor Academic Block GB Pant Hospital 1,Jawaharlal Nehru Marg New Delhi 110002

Central
DELHI
110002
India 
Phone  7389529125  
Fax    
Email  arpan040788@gmail.com  
 
Source of Monetary or Material Support  
None, Govt Medical college 
 
Primary Sponsor  
Name  Department of Gastroenterology G B Pant Hospital  
Address  Department of Gastroenterology Academic Block 2nd floor, GB Pant Hospital New Delhi-110002 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  GB Pant Hospital New Delhi  Academic block 2nd floor 1, Jawaharlal Nehru Marg, 64 Khamba, New Delhi, Delhi 110002
Central
DELHI 		 7389529125

barjeshchandershama@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee/Maulana Azad Medical college and Associated GB Pant Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K740||Hepatic fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lactulose plus rifaximin plus L ornithine L Asoartate(LOLA) vs lactulose rifaximin and placebo  The patients will be randomized to receive either Group A or Group B. Both groups will receive standard care treatment. Group A will receive Rifaximin + Lactulose, + iv LOLA while group B will be given Lactulose + Rifaximin+ iv placebo. Lactulose syrup: 30-120 ml in three divided doses through a nasogastric tube/ orally to produce 2-3 semi formed stools and/or lactulose retention enemas (300 ml lactulose +700 ml water) twice daily. In patients with constipation, higher dosage of oral Lactulose (120 ml T.I.D) along with Lactulose Enemas will be given. LOLA (only Group A )at dose of 30 grams daily, by intravenous infusion over 24 hours. LOLA will be supplied as ampoules (each ampoule containing 5 grams LOLA in 10 ml clear solution). LOLA (6 ampules containing 5 grams of the drug in 10 ml solution) will be used, as intravenous infusion at the rate of 21ml/hour, over 24 hour for 5 days. Placebo (only group B) will be supplied in similar ampoules with each ampoule containing 10 ml clear solution. There will no difference in appearance and the way of administration.  
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Age of patients 18-70 years.
2. Hepatic cirrhosis based on clinical, biochemical, radiological and/or histological data
3. Patients with overt acute grade 3 and 4 HE, according to the West Haven criteria, with or without precipitating factors
 
 
ExclusionCriteria 
Details  1.Acute on chronic liver failure
2.Hepatocellular carcinoma
3.Wilson’s disease
4.Advanced cardiac or pulmonary disease
5.Neurologic disease (including head injury and drug intoxication) CNS active drugs.
6.Pregnancy or breast feeding
7.Cirrhotics with h/o HE already taking L-Ornithine – L –Aspartate
8.Presence of underlying chronic renal failure (serum creatinine > 1.5mg/dl)
9.Psychiatric illness; patients who are on sedatives and antidepressants
10.Those who do not give informed consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reversal of HE or improvement of HE by 2 grades (according to West Havens Criteria) and mental state grade after 5 days of treatment  Reversal of HE or improvement of HE by 2 grades (according to West Havens Criteria) and mental state grade after 5 days of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Blood Ammonia Levels   5 days 
Serum Cytokines levels
(IL-1,IL-6,IL-10,TNF-alpha,S. Endotoxins) 		 5 days 
Liver related death  28 days 
Death due to other causes  28 days 
Discontinuation due to adverse effects   5 days 
Rate of Recovery from HE   5 days 
Length of hospital stay  28 days 
Mortality (time frame 4 weeks)  28 days 
Cause of Death  28 days 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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   Phase 2 
Date of First Enrollment (India)   07/05/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a randomized, double blind, parallel group, single centre trial comparing the safety and efficacy of lactulose plus rifaximin versus lactulose plus rifaximin plus L Ornithine L Aspartete in 124 patients wwith Cirrhosis with Hepatic encephalopathy Grade 3 or 4 as per West Haven’s criteria and will be conducted at single centre in India,
The primary outcome measure will be Reversal of HE or improvement of HE by 2 grades (according to West Havens Criteria) and mental state grade after 5 days of treatment.
The Secondary Outcomes will be

1.      Blood Ammonia Levels

2.      Serum Cytokines levels (time frame 5 days). Changes in serum cytokines measured at baseline and after 5 days of treatment

a.       Interleukin 1

b.      Interleukin 6

c.       Interleukin 10

d.      TNF

e.       S. Endotoxins

      3.  Liver related death

      4.  Death due to other causes

      5.  Discontinuation due to adverse effects

      6.  Rate of Recovery from HE

      7.  Length of hospital stay

      8.  Mortality (time frame 4 weeks)

      9.  Cause of Death

 
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