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TO ASSESS EFFICACY OF DAPAGLIFLOZIN IN PATIENTS WITH CIRRHOSIS WITH DIABETES AS COMPARED TO STANDARD MEDICAL REGIMEN

ASSESSMENT OF EFFICACY OF DAPAGLIFLOZIN IN PATIENTS OF LIVER CIRRHOSIS WITH DIABETES MELLITUS AS COMPARED TO STANDARD MEDICAL TREATMENT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054459
Enrollment
80
Registered
2023-06-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: K742- Hepatic fibrosis with hepatic sclerosis

Interventions

Intervention1: Dapagliflozin: To be given in 10 mg OD oral route daily once only for at least 6 months Control Intervention1: Insulin with or without metformin: Insulin to be given as long acting or s

Sponsors

Pt BD Sharma Institute of Medical Science, Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Patients with liver cirrhosis having age 18years to 70years with Diabetes Mellitus requiring drug treatment. Patients who are willing to participate

Exclusion criteria

Exclusion criteria: Age 70years. Cerebrovascular disorder, any neurological disorder including dementia/Alzheimerâ??s etc.Pregnancy.Chronic kidney disease . Any malignancy excluding Hepatocellular Carcinoma .Patient who refused to give consent.

Design outcomes

Primary

MeasureTime frame
Control of Diabetes as defined by Fasting blood sugar 80 to 130 mg/dl and 2hr post prandial blood sugar below 180 mg/dl at 1, 3 and 6 monthTimepoint: 1st ,3rd and 6th month

Secondary

MeasureTime frame
Episodes of hypoglycemia, Compliance to treatment, Status of Ascites, episodes of spontaneous bacterial peritonitis (SBP)/ Upper Gastrointestinal bleeding/ jaundice/ Hepatorenal Syndrome(HRS) , Change in ChildTurcottePugh(CTP) score and MELD 3.0 score from baseline at 3 and 6 month.Timepoint: 3rd and 6th month

Countries

India

Contacts

Public ContactDr Tarana Gupta

Pt.BDS institute of Medical Science,Rohtak

taranagupta@gmail.com9914048899

Outcome results

None listed

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