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CTRI Number  CTRI/2026/01/101491 [Registered on: 19/01/2026] Trial Registered Prospectively
Last Modified On: 18/09/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The role of new drug "empagliflozin" in refractory ascites with cirrhosis 
Scientific Title of Study   A study to evaluate the efficacy of SGLT2 inhibitor (Empagliflozin) as an adjunctive to SoC therapy in the management of refractory ascites in Cirrhosis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Varun Mehta 
Designation  Professor Department of Gastroenterology 
Affiliation  DMCH Ludhiana 
Address  Room No. 47, Department of Gastroenterology, Dayanand Medical College and Hospital, Tagore Nagar, Civil LInes, Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9876548408  
Fax    
Email  varun_mehta05@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Varun Mehta 
Designation  Professor Department of Gastroenterology 
Affiliation  DMCH Ludhiana 
Address  Room No. 47, Department of Gastroenterology, Dayanand Medical College and Hospital, Tagore Nagar, Civil LInes, Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9876548408  
Fax    
Email  varun_mehta05@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Varun Mehta 
Designation  Professor Department of Gastroenterology 
Affiliation  DMCH Ludhiana 
Address  Room No. 47, Department of Gastroenterology, Dayanand Medical College and Hospital, Tagore Nagar, Civil LInes, Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9876548408  
Fax    
Email  varun_mehta05@rediffmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital, Tagore Nagar, Ludhiana, Punjab, India-141001 
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital 
Address  Dayanand Medical College and Hospital, Tagore Nagar, Civil LInes, Ludhiana, Punjab, India-141001 
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 
varun mehta  Dayanand Medical College and Hospital  Tagore NAgar, Ludhiana
Ludhiana
PUNJAB 		 6280090491

varun_mehta05@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Empagliflozin  Empagliflozin 10 mg/day for 12 weeks in addition to Standard of Care Therapy (Dietary sodium restriction, Diuretics, IV albumin and Large Volume Paracentesis as required) in patients with refractory ascites 
Comparator Agent  Standard of Care Therapy  Standard of Care Therapy (Dietary sodium restriction, Diuretics, IV albumin and Large Volume Paracentesis as required) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Cirrhosis (clinical, imaging, and/or histological) with refractory ascites (due to portal hypertension).
Subjects who are willing and able to comply with treatment plan, laboratory tests.
Subjects who are willing to provide a written informed consent
 
 
ExclusionCriteria 
Details  - Previous history of documented hypoglycemia (in the preceding 1 month)
- Previous history of repeated urinary tract infection (UTI) (more than 2 infections within 6 months),
- Pregnant or lactating females,
- Previous history of hypersensitivity to any SGLT2 inhibitor
- Serum sodium < 125 meq/L
- History of peripheral vascular disease (ulcer/gangrene/amputation)
- Severe renal impairment (eGFR <30 mL/min/1.73 m²) or dialysis requirement
- Active alcohol use with last alcohol intake 1 month back
- GI bleeding in the previous 1 month
- Overt HE in the previous 1 month
- Treatment with drugs with known effects on systemic and renal hemodynamics within 7 days of inclusion, except beta blockers
- Previous history of diabetic ketoacidosis,
- Child–Pugh score of 12 or more
- Hepatocellular carcinoma
- Portal Vein Thrombosis
- SBP
- Mixed ascites (etiology of ascites other than portal hypertension)
- Patients opting for liver transplant or TIPS
- H/o pancreatitis/pancreatic surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of therapeutic paracenteses per patient and total paracentesis volume during 12 weeks  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in abdominal girth (cm) from baseline  Weeks 4, 8 and 12 
Change in body weight (kg)  Weeks 4, 8 and 12 
Change in eGFR from baseline   Weeks 4, 8 and 12 
Change in HbA1c   12 weeks 
Change in prognostic scores (CTP, MELD Na) from baseline   Weeks 4, 8 and 12 
Change in serum sodium and spot urinary sodium  Weeks 4, 8 and 12 
Incidence of AKI (as per KDIGO), serious adverse events (including SGLT2-i related AEs)  12 weeks 
Frequency of hepatic encephalopathy  12 weeks 
Frequency of SBP, UTI and other infections  12 weeks 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   30/01/2026 
Date of Study Completion (India) 27/05/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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   Ascites is the most common complication of cirrhosis, continued up to 60% of the patients with a 10 years of diagnosis.  Among these 5 to 10% develop refractory ascites, defined as ascites that cannot be mobilized or recur rapidly despite dietary sodium restriction and maximal diuretic therapy.  If there is a worse prognosis with median survival of less than 6 months.  Current treatment plan diuretics include large-volume paracentesis, TIPS, vasoconstrictor therapy albumin infusions and diuretics.  However these approaches of limitation such as procedure complication, recurrence of ascites and cost issues.  Sodium glucose Co. transporter 2 (SGLT-2) inhibitors are relatively new class of antihyperglycemic agents have been shown to be renal protective and cardioprotective benefits beyond glycemic control.  They are not benefiting glucose and sodium reabsorption in the proximal and ventricular producing osmotic diuresis natriuresis independent of aldosterone.  This mechanism evaluation and patient with cirrhosis and ascites, with activation of the renin-angiotensin-aldosterone system aortic distance may have sclerosing pathophysiology. 
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