| CTRI Number |
CTRI/2025/10/096351 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand the health, medicine side effects, and quality of life of kidney patients who take many medicines. |
|
Scientific Title of Study
|
ASSESSMENT OF DISEASE STATUS, ADVERSE EVENTS AND QUALITY OF LIFE DUE TO POLYPHARMACY AMONG CHRONIC KIDNEY DISEASE PATIENTS: A PROSPECTIVE 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 |
Darshan Belagali |
| Designation |
M Pharm (Pharmacy Practice) Post graduate student |
| Affiliation |
kLE College of Pharmacy Belagavi |
| Address |
Department of Pharmacy Practice Room no 15 4th floor KLE College of Pharmacy JNMC CAMPUS, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8105846709 |
| Fax |
|
| Email |
darshanbelagali2933@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Geetanjali S Salimath |
| Designation |
Associate Proffesser |
| Affiliation |
KLE College of Pharmacy BelagavikLE College of Pharmacy Belagavi |
| Address |
Department Of Pharmacy Practice Room no 15 4th floor KLE College Of Pharmacy JNMC CAMPUS, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9902687176 |
| Fax |
|
| Email |
geetnjalisalimath@klepharm.edu |
|
Details of Contact Person
Public Query
|
| Name |
Geetanjali S Salimath |
| Designation |
Associate Proffesser |
| Affiliation |
KLE College of Pharmacy BelagavikLE College of Pharmacy Belagavi |
| Address |
Department Of Pharmacy Practice Room no 15 4th floor KLE College Of Pharmacy JNMC CAMPUS, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9902687176 |
| Fax |
|
| Email |
geetnjalisalimath@klepharm.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KLE College of Pharmacy Belagavi |
| Address |
KLE College of Pharmacy
JNMC CAMPUS, Nehru Nagar, Belagavi, Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Geetanjali S Salimath |
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre, Belagavi |
Nephrology OPD Unit room no 28 2nd floor Front Entrance NH services road, Nehru Nagar Belagavi Karnataka 590010
Belgaum
KARNATAKA |
9902687176
geetnjalisalimath@klepharm.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLECOPBGM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with chronic kidney disease Stages 1-5 or those receiving dialysis.
2.Patients Taking five or more medications concurrently.
3.Adults aged 18 years or older.
4.Patients Who Provide Informed Consent to Participate in the study.
5.Referred Patients are included
|
|
| ExclusionCriteria |
| Details |
1.Patients with Cognitive impairment that prevents from completing surveys or providing Informed Consent.
2.Patients who are not willing to provide consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •To Evaluate the effect of Polypharmacy on disease status in Patients with Chronic Kidney Disease. |
One-time assessment at the time of enrollment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •To assess and evaluate the effect of Polypharmacy on Quality of Life in Chronic Kidney Disease Patients using Medication Related Quality of Life (MRQOL). |
One-time assessment at the time of enrollment. |
| •To assess and report the adverse events in Patients with Chronic Kidney Disease. |
One-time assessment at the time of enrollment. |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
28/10/2025 |
| 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="0"
Months="7"
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 prospective study aims to evaluate the impact of
polypharmacy on disease status, adverse events, and quality of life among
patients with chronic kidney disease (CKD). Patients with CKD stages 1–5,
including those on dialysis, who are taking five or more medications will be
enrolled. The primary objective is to assess the effect of polypharmacy on
disease status. Secondary objectives include identifying and reporting adverse
drug events and evaluating quality of life using the Medication-Related Quality
of Life (MRQoL) questionnaire. Adults aged 18 years and above who provide
informed consent will be included, while patients with cognitive impairment or
unwilling to give consent will be excluded.
|