| CTRI Number |
CTRI/2024/11/076376 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the effect of Dapagliflozin in patients of Liver Cirrhosis with Ascites |
|
Scientific Title of Study
|
Assessment of efficacy of Dapagliflozin in patients of Liver Cirrhosis with Ascites |
| 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 Ravi Dhayal |
| Designation |
Junior Resident |
| Affiliation |
Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, Rohtak , Haryana |
| Address |
Department of Medicine Pt. B. D Sharma PGIMS , Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416401616 |
| Fax |
|
| Email |
ravidhayal32@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tarana Gupta |
| Designation |
Senior Professor |
| Affiliation |
Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, Rohtak , Haryana |
| Address |
Department of Medicine, Pt. B. D. Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9914048899 |
| Fax |
|
| Email |
taranagupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Dhayal |
| Designation |
Junior Resident |
| Affiliation |
Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, Rohtak , Haryana |
| Address |
Department of Medicine, Pt. B. D. Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416401616 |
| Fax |
|
| Email |
ravidhayal32@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B. D. Sharma PGIMS , Rohtak, Haryana, India , 124001 |
|
|
Primary Sponsor
|
| Name |
No |
| Address |
No |
| Type of Sponsor |
Other [No] |
|
|
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 Ravi Dhayal |
Pt. B.D. Sharma Post Graduate Institute of Medical Sciences |
Rohtak, Haryana, India,124001
Rohtak
HARYANA |
9416401616
ravidhayal32@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B. D. Sharma PGIMS/UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K703||Alcoholic cirrhosis of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dapagliflozin Group |
Tablet Dapagliflozin 10mg orally once daily for 6 months in addition to standard medical treatment |
| Comparator Agent |
Furosemide and Spironolactone Group |
Standard medical treatment (salt restricted diet) and oral furosemide 40 to 160 mg once daily with oral spironolactone 100 to 400 mg once daily for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All the patients of liver cirrhosis with new onset ascites and patients of ascites uncontrolled on diuretics therapy shall be enrolled.
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years, Cerebrovascular disorder, any neurological disorder including dementia/ Alzheimer’s etc., Pregnancy and Any extrahepatic malignancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in grade of Ascites |
3 and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Episodes of Acute kidney injury (AKI)/ spontaneous bacterial peritonitis/ hepatic encephalopathy/ jaundice and Change in CTP and MELD score. |
3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="1"
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
|
All the new patients of Liver Cirrhosis with Ascites and patients of Ascites uncontrolled on diuretics shall be enrolled. The study shall be conducted in the Hepatology clinic , Department of Medicine, Pt B.D. Sharma PGIMS , Rohtak. The study is a parallel group, open label , randomised controlled study. Enrolment shall be done for first 6 months , all patients shall be followed upto 6 months after enrolment. |