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CTRI Number  CTRI/2025/09/094043 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 31/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To Evaluate Drug Awareness, Medication Adherence and Drugs Prescribed in Patients of Nephrotic Syndrome 
Scientific Title of Study   Evaluation of Drug Awareness, Medication Adherence and Prescription Patterns in Patients of Nephrotic Syndrome Attending a Tertiary Care Hospital: A Cross-sectional, Questionnaire-based 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 Raakhi Tripathi 
Designation  Associate Professor 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Pharmacology and Therapeutics, College building, First Floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra India

Mumbai
MAHARASHTRA
400012
India 
Phone  9821724700  
Fax    
Email  lookon@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Avanti Kajrolkar 
Designation  Junior Resident 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Pharmacology and Therapeutics, College building, First Floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra India

Mumbai
MAHARASHTRA
400012
India 
Phone  8454009253  
Fax    
Email  avkajrolkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Raakhi Tripathi 
Designation  Associate Professor 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Pharmacology and Therapeutics, College building, First Floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra India

Mumbai
MAHARASHTRA
400012
India 
Phone  9821724700  
Fax    
Email  lookon@rediffmail.com   
 
Source of Monetary or Material Support  
Seth Gordhandas Sunderdas Medical College & King Edward Memorial Hospital, Acharya Donde Marg, Parel, Mumbai 400012, Maharashtra, India 
 
Primary Sponsor  
Name  Dr Raakhi Tripathi 
Address  Department of Pharmacology & Therapeutics, College Building, First Floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra, India  
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 Raakhi Tripathi  Seth GS Medical College and KEM Hospital  Nephrology OPD, Department of Nephrology, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra and Pediatric OPD, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra
Mumbai
MAHARASHTRA 
9821724700

lookon@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC)-III Relating to Biomedical and Health Research (BHR), Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N04||Nephrotic syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  A) For Pediatric patients

1. Male or female patients with confirmed diagnosis of Nephrotic Syndrome attending Pediatric or Nephrology OPD.
2. Patients aged 2 years to 18 years.
3. Patients who have been on treatment for more than 1 month.

B)For Adult patients

1. Male or female patients with confirmed diagnosis of Nephrotic Syndrome attending Nephrology OPD.
2. Patients aged 18 years to 60 years.
3. Patients who have been on treatment for more than 1 month.
 
 
ExclusionCriteria 
Details  A) For Pediatric patients

1. Parents/caregivers not willing to give informed consent
2. Patients (aged 7-18 years) not willing to give assent
3. Patients admitted in IPD and emergency departments

B) For Adult patients

1. Patients not willing to give informed consent
2. Patients admitted in IPD and emergency departments

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.The primary variable is percentage of patients stating ‘Yes/No’ for each item of the Drug Awareness Questionnaire.
2.Mean awareness score will be calculated
3. Mean Awareness Score will be correlated with demographic factors (Age, gender,
occupation, education and socio-economic status as per Kuppuswamy scale)
 
As this is a cross-sectional survey, outcomes will be assessed at end of study, i.e, 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate perceived Medication Adherence which will be assessed by the percentage of patients stating ‘Yes/No’ for each item of the Medication Adherence Questionnaire.
For evaluating actual Medication Adherence, the percentage of Medication Adherence will be calculated using pill count method formula.
 
As this is a cross-sectional survey, outcomes will be assessed at end of study, i.e, 18 months. 
To study the pattern of drugs used in the treatment of Nephrotic Syndrome  As this is a cross-sectional survey, outcomes will be assessed at end of study, i.e, 18 months 
To evaluate the prescribed drug regimen as per the package insert of the prescribed drugs
 
As this is a cross-sectional survey, outcomes will be assessed at end of study, i.e, 18 months 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   18/09/2025 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  Data will be shared without revealing identity of participant for publication and presentations.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response (Others) -  Questionnaire, Case Record Form
  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [avkajrolkar@gmail.com].

  6. For how long will this data be available start date provided 26-08-2025 and end date provided 31-12-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Nephrotic Syndrome is the most common glomerular disease in children and an important cause of chronic kidney disease (CKD) in adults. It is defined by the presence of proteinuria, hypoalbuminemia, and edema, often accompanied by hyperlipidemia and lipiduria. Management involves corticosteroids as the mainstay in children, with treatment response determining prognosis. Adults are treated based on underlying histology, with corticosteroids and second-line immunosuppressants forming the cornerstone of therapy. Nephrotic Syndrome is associated with multiple complications including edema, hypertension, infections, hyperlipidemia, and thromboembolic events, which are managed by supportive medications such as diuretics, antihypertensives, hypolipidemic drugs, antimicrobials and anticoagulants.

Poor medication adherence in patients of nephrotic syndrome has been linked to increased frequency of relapses, steroid resistance, complications, and increased healthcare costs. Hence, medication adherence is a vital focus for overall disease outcomes in pediatric and adult nephrotic syndrome patients. There have been very few studies evaluating medication adherence in Nephrotic Syndrome in India. Hence, this study has been undertaken to assess medication adherence. Patient and caregiver awareness plays an important role in effective management of the condition. Adequate knowledge and awareness can help overcome the problems of poor adherence, misuse of medications, late identification of relapses and preventable complications. There has been no study done in India focused on detailed evaluation of Drug Awareness in Nephrotic Syndrome- including side effects and self-medication. There has also been no study on evaluation on Drug Awareness in adult as well as pediatric patients of nephrotic syndrome. Hence, the present study aims to evaluate Drug Awareness in patients of Nephrotic Syndrome

The treatment involves several drug classes with multiple drugs under each, resulting in variability in prescription patterns. There are only a few studies evaluating prescription patterns in Nephrotic Syndrome from Western India and there has been no study on evaluation of prescription patterns of nephrotic syndrome in Maharashtra. Hence, this study aims to assess prescription patterns in patients of nephrotic syndrome to identify real world treatment trends, adherence to standard treatment guidelines and variations across the age groups and healthcare providers

Patients of Nephrotic Syndrome have varying degrees of renal impairment for which dose adjustments are necessary. Improper doses of drugs can increase the risk of treatment failure and can lead to side-effects. Hence, assessing appropriateness of renal dose adjustments in patients of Nephrotic Syndrome is also necessary.

 

Till date, there has been no single study comprehensively evaluating Drug Awareness, perceived Medication Adherence and Prescription Patterns in Nephrotic Syndrome. Hence, the present study has been planned.

Primary Objective:

To evaluate the Drug Awareness in Adult patients & Parents/Caregivers of children suffering from Nephrotic Syndrome using a validated Drug Awareness Questionnaire.

Secondary Objective: 

  1. To evaluate perceived medication adherence in patients of Nephrotic Syndrome using a validated Medication Adherence Questionnaire.

  2. To evaluate the prescription pattern of drugs used in treatment of patients of Nephrotic Syndrome.

  3. To evaluate the prescribed drug regimen as per the package insert of the prescribed drugs. 


The sample size will be 50 pediatric patients and 200 adult patients which is a total of 250 patients. Sample size has been calculated by convenience sampling method.

Primary and Secondary variables will be measured. Statistical analysis will be done.


 
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