| 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
|
|
|
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
|
|
|
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. |