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A study to find out if Dapagliflozin can help reduce abdominal fluid in liver cirrhosis when usual medicines do not work.

Safety and Efficacy of SGLT-2 Inhibitors in Liver Cirrhosis Patients with Refractory Ascites : A Randomised clinical Control Trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098898
Enrollment
72
Registered
2025-12-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K740- Hepatic fibrosis

Interventions

Intervention1: Dapagliflozin, 10mg: Dose: 10mg/day. Frequency: once a day, with or without meal. Route of administration: oral. Total duration of intervention: 6 months Control Intervention1: Standa

Sponsors

Dr Surender Kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Liver cirrhosis patients with refractory ascites whom ascites is not recovered with best standard medical therapy and large volume paracentasis.

Exclusion criteria

Exclusion criteria: patients who have chronic kidney disease and history of infections, hypoglycemia, hyponatriemia, fractures, acute kidney injury.

Design outcomes

Primary

MeasureTime frame
Control of ascites, complete response, partial response and no response at the follow up of 6 months.Timepoint: Control of ascites, complete response, partial response and no response at the follow up of 6 months.

Secondary

MeasureTime frame
Change in 24hours urinary sodium ,24 hours urinary volume, EGFR, survival at six months, adverse events throught the follow up like subacute bacterial peritonitis, hypoglycemia, acute kidney injury, pneumonia.Timepoint: From taking into recruitment till 6 months of follow up after taking in the randomization arms.

Countries

India

Contacts

Public ContactSurender Kumar

Department of Gastroenterology, Dr S.N. Medical College and MDM Hospital, Jodhpur, Rajasthan, India

profsunildadhich@gmail.com9414136440

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026