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CTRI Number  CTRI/2026/02/104411 [Registered on: 20/02/2026] Trial Registered Prospectively
Last Modified On: 19/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Randomized control trial on the effects of rifaximin and midodrine combined with standard diuretic therapy versus midodrine with standard diuretic therapy in chronic liver disease patients with refractory ascites in a tertiary hospital  
Scientific Title of Study   Randomized control trial on the effects of rifaximin and midodrine combined with standard diuretic therapy versus midodrine with standard diuretic therapy in chronic liver disease patients with refractory ascites 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr ASHWIN PAUL 
Designation  Senior Residentt 
Affiliation  JSS MEDICAL COLLEGE HOSPITAL 
Address  Department of Medical Gastroenterology, JSS Medical College and Hospital, Mahatma Gandhi Road, Mysuru.

Mysore
KARNATAKA
570004
India 
Phone  8086335660  
Fax    
Email  drashwinpaul@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Deepak Suvarna 
Designation  Professor and Head 
Affiliation  JSS MEDICAL COLLEGE HOSPITAL 
Address  Department of Medical Gastroenterology, JSS Medical College and Hospital, Mahatma Gandhi Road, Mysuru.

Mysore
KARNATAKA
570004
India 
Phone  9964380249  
Fax    
Email  drdeepaksuvarna@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr ASHWIN PAUL 
Designation  DM STUDENT 
Affiliation  JSS MEDICAL COLLEGE HOSPITAL 
Address  Department of Medical Gastroenterology, JSS Medical College and Hospital, Mahatma Gandhi Road, Mysuru.

Mysore
KARNATAKA
570004
India 
Phone  8086335660  
Fax    
Email  drashwinpaul@gmail.com  
 
Source of Monetary or Material Support  
JSS Medical College and Hospital Medical Gastroenterology, JSS Medical College and Hospital, Mahatma Gandhi Road, Mysuru-570004 
 
Primary Sponsor  
Name  Not applicable 
Address  Not applicable 
Type of Sponsor  Other [] 
 
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 ASHWIN PAUL  JSS HOSPITAL  Room No: 1101 Department of Medical Gastroenterology, JSS Medical College and Hospital, Mahatma Gandhi Road, Mysuru.
Mysore
KARNATAKA 
8086335660
082123355556
drashwinpaul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE. JSS MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R188||Other ascites,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  midodrine+ lasilactone/dytor or both  Midodrine 5mg per orally three times a day Spirololactone 50mg per orally once a day(morning) Torsemide 10mg per orally once a day(morning) 
Intervention  rifaximine + midodrine+ lasilactone/dytor or both   Rifaximine 550mg per orally twice a day Midodrine 5mg per orally three times a day Spirololactone 50mg per orally once a day(morning) Torsemide 10mg per orally once a day(morning) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients diagnosed
with Chronic liver
disease with refractory
ascites.
Patients above the age
of 18 years.
Patients of both gender
Informed consent from
the patient/ a legally
authorised
representative 
 
ExclusionCriteria 
Details  noncirrhotic causes of

ascites
primary renal medical
diseases,
any grade of unresolved
hepatic encephalopathy
until it has improved
and stabilized
active gastrointestinal
bleeding, Hepato-renal
syndrome,
previous antibiotic
prophylaxis for
spontaneous bacterial
peritonitis,
the presence of
hepatocellular
carcinoma and portal
vein thrombosis
active cardiovascular
disease, systemic
hypertension
drugs that affect
systemic and renal
hemodynamic
active alcohol
consumption 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Access whether adding
Rifaximin and midodrine to
standard diuretic therapy
Enhances diuresis and control of
ascites with subsequent weight
loss in patients with refractory
ascites 
12 WEEKS  
 
Secondary Outcome  
Outcome  TimePoints 
To access the improvement in
renal function and development
of drug related side affects
after adding adding Rifaximin
and midodrine to standard 
90 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   19/03/2026 
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="2"
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  

Refractory ascites is a serious complication of advanced liver cirrhosis in which ascites does not respond to sodium restriction and standard diuretic therapy or recurs rapidly after therapeutic paracentesis. It is associated with poor prognosis and high mortality. A proportion of patients with cirrhosis and ascites eventually develop refractory ascites, and mortality in this group remains high within one to two years.

Liver transplantation is the only definitive treatment for refractory ascites but is not feasible for many patients due to limited availability and medical or socioeconomic constraints. As a result most patients are managed with diuretics and repeated large volume paracentesis. Diuretic therapy in these patients often leads to complications such as hyponatremia acute kidney injury and hepatic encephalopathy. Recurrent paracentesis increases the risk of infections including spontaneous bacterial peritonitis.

Midodrine improves renal perfusion and renal function by increasing systemic vascular resistance. Rifaximin reduces oxidative stress and splanchnic vasodilation and may improve circulatory dysfunction in cirrhosis. Previous studies have suggested that adding midodrine and rifaximin to standard therapy can enhance diuresis improve renal and systemic hemodynamics and increase short term survival in patients with refractory ascites.

However there is limited data from India regarding the combined use of rifaximin and midodrine in refractory ascites. This study is designed to evaluate whether the addition of rifaximin and midodrine to standard therapy improves diuresis and survival outcomes in patients with refractory ascites.

 
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