FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/095797 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening
Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   How pharmacist education can help patients using prescribed drug reduce side effects: A study at a teaching hospital. 
Scientific Title of Study   Impact Of Clinical Pharmacist Developed Educational Tool And Counselling on ADR’s of SGLT2 Inhibitor Users at Tertiary Care Teaching Hospital: A Randomized Controlled Study. 
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 Anushree Deshpande 
Designation  Assistant Professor and Guide 
Affiliation  KLE College of Pharmacy, Belagavi  
Address  Room no 15, Department of Pharmacy practice, KLE College of Pharmacy, Belagavi, Nehru Nagar, Belagavi, Karnataka - 590010.

Belgaum
KARNATAKA
590010
India 
Phone  8792998483  
Fax    
Email  anushreedeshpande@klepharm.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Anushree Deshpande 
Designation  Assistant Professor and Guide 
Affiliation  KLE College of Pharmacy, Belagavi  
Address  Room no 15, Department of Pharmacy practice, KLE College of Pharmacy, Belagavi, Nehru Nagar, Belagavi, Karnataka - 590010.

Belgaum
KARNATAKA
590010
India 
Phone  8792998483  
Fax    
Email  anushreedeshpande@klepharm.edu  
 
Details of Contact Person
Public Query  
Name  Advita Ganachari  
Designation  Pharm D Student  
Affiliation  KLE College of Pharmacy, Belagavi  
Address  Room no 15, Department of Pharmacy practice, KLE College of Pharmacy, Belagavi, Nehru Nagar, Belagavi, Karnataka - 590010.

Belgaum
KARNATAKA
590010
India 
Phone  8431667986  
Fax    
Email  advitamg@gmail.com  
 
Source of Monetary or Material Support  
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre, Front Entrance, NH Service Road, Nehru Nagar, Belagavi, Karnataka - 590010 
 
Primary Sponsor  
Name  Dr Anushree Deshpande 
Address  KLE College of Pharmacy, Nehru nagar, Belagavi, KA, 590010.  
Type of Sponsor  Other [Self] 
 
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 
Dr Anushree Deshpande   KLEs Dr.Prabhakar Kore Hospital and Medical Research Centre, Belagavi.   Front Entrance, NH Service road, Nehru nagar, Belagavi, KA - 590010.
Belgaum
KARNATAKA 		 8792998483

anushreedeshpande@klepharm.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLECOPBGM ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N181||Chronic kidney disease, stage 1, (2) ICD-10 Condition: N182||Chronic kidney disease, stage 2 (mild), (3) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), (4) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (5) ICD-10 Condition: I210||ST elevation (STEMI) myocardial infarction of anterior wall, (6) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, (7) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, (8) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  standard care will be given 
Intervention  Pharmacist intervention   Minimizing and Preventing ADR through Patient counselling every month for 3 months and handing out educational tool at the first intervention(card).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1) Patients aged more than or equal to 18 years.
2) The literate patients diagnosed with any cardiovascular disease, T2DM and CKD.
3) All patients on SGLT2 inhibitors, either as monotherapy or in combination with other drugs.
4) Patients willing to provide written consent for participation in the study.  
 
ExclusionCriteria 
Details  1) The patient with known history of Genital infections and UTI before taking SGLT2i.
2) Patient with incomplete demographics and laboratory findings.
3) Patients with T1 DM, Immunocompromised like STDs, serious complications like Cancer, terminally ill, cognitive impaired patients. etc.
4) Pregnant and lactating women. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Awareness on safe use of SGLT2 inhibitors.   1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in incidence & severity of ADRs (based on WHO & Hartwig Siegel scales).   every 30 days for 3 months 
Improved patient adherence to sick day rules & hygiene practices.   every 30 days for 3 months 
Validate use of pharmacist-developed educational tool (card) in chronic disease management.    
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   24/10/2025 
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   This is a randomized, double blind, parallel group study, where we will include people on SGLT2 inhibitor as monotherapy or in combination with other drugs and must be a patient of T2DM, cardiovascular disease and/or chronic kidney disease till stage 4. Awareness on safe use of SGLT2 inhibitors will be given to patients on SGLT2 inhibiting drugs through patient counselling about sick day rule, early detection of ADR, immediate measures to be taken if ADR occurs, providing patient information leaflet and patient educational card. As secondary outcome, patients adherence to sick day rule and hygiene practices will be improved and as a result incidence and severity of ADRs will be reduced.  
Close