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CTRI Number  CTRI/2024/07/069861 [Registered on: 03/07/2024] Trial Registered Prospectively
Last Modified On: 02/07/2024
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To check the effect of zinc as an add on therapy to prednisolone for producing early improvement in pediatric nephrotic syndrome patients 
Scientific Title of Study   To evaluate the efficacy and safety of zinc as an add on therapy to prednisolone for producing early remission of pediatric nephrotic syndrome: A randomized controlled trial 
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 Alok Kaushik 
Designation  Postgraduate student 
Affiliation  BPS Govt .Medical College for women,Khanpur Kalan,Sonipat 
Address  Department of Pharmacology,Bhagat Phool Singh Govt.MedicalCollege For Women,Khanpur Kalan,Sonipat ,Haryana

Sonipat
HARYANA
131305
India 
Phone  9990353462  
Fax    
Email  233alok@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Garima Bhutani 
Designation  Proffesor 
Affiliation  BPS Govt Medical college For women 
Address  Department of Pharmacology,Bhagat Phool singh Govt.Medical college ,Khanpur Kalan ,Sonipat ,

Sonipat
HARYANA
131305
India 
Phone  9992108132  
Fax    
Email  drgarimaahuja2013@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Alok Kaushik 
Designation  Post Graduation 
Affiliation  BPS Govt Medical College For women 
Address  Department of Pharmacology BPS Govt Medical College ,Khanpur Kalan ,Sonipat

Sonipat
HARYANA
131305
India 
Phone  9990353462  
Fax    
Email  233alok@gmail.com  
 
Source of Monetary or Material Support  
BPS Govt Medical College For women 
 
Primary Sponsor  
Name  Bhagat Phool Singh Govt.Medical College For Women 
Address  Khanpur Kalan ,Sonipat ,Haryana 131305 
Type of Sponsor  Government medical college 
 
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 Alok Kaushik  BPS Govt. Medical College For Women  Paediatrics IPD, BPSGMC(W), Khanpur Kalan, Sonipat, Haryana, 131305
Sonipat
HARYANA 
9990353462

233alok@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N040||Nephrotic syndrome with minor glomerular abnormality,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  tablet prednisolone and syrup zinc  tablet prednisolone 2mg/kg/day per oral(maximum 60mg) in single or divided doses for 6 weeks and syrup zinc 20 mg/kg per oral for 14 days or till the day of remission whichever is longer 
Comparator Agent  Tab prednisolone .   Tab prednisolone in a dose of2mg/kg/day per oral(maximum 60mg) in a single or divided doses for 6 weeks) followed by 1.5mg/kg per oral(maximum 40mg as a single morning dose on alternate days for next 6weeks 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Hospitalized children of age group 1-15 years presenting with 1st episode of nephrotic syndrome (as per criteria given in annexure 1)
2. Children whose parents/guardians are willing to give written informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Children whose parents/guardians are not willing to give written informed consent to participate in the study.
2. Children with malabsorption
3. Children with malnutrition
4. Children with hepatic problems
5. History of chronic illness
6. Secondary causes of nephrotic syndrome.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Weight (in kgs), blood pressure, and fluid intake, and urinary protein, spot urinary albumin: creatinine ratio, 24 hr urine output and abdominal girth of the patients will be monitored at baseline and 24 hourly.  baseline and 24 hourly till the day of remission 
 
Secondary Outcome  
Outcome  TimePoints 
Total serum protein, serum albumin, serum globulin, A:G ratio, serum cholesterol, serum creatinine and serum urea will be estimated at baseline and on the day of remission   1st day and on the day of remission 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   14/08/2024 
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="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 - NO
Brief Summary  

Nephrotic syndrome is characterized by massive proteinuria, hypoalbuminemia, edema, hyperlipidemia, hypertension and rarely hematuria. It is an important chronic disease in children of age 2 to 7 year old. Management of nephrotic syndrome includes prednisolone 2mg/kg/day (maximum 60 mg) in single or divided doses for 6 weeks, followed by 1.5 mg/kg (maximum 40 mg) as a single morning dose on alternate days for next 6 weeks. The present study is designed to evaluate the efficacy and safety of zinc as an add on therapy to prednisolone for producing early remission of pediatric nephrotic syndrome. 62 children fulfilling the inclusion criteria will be included in the study. The total duration of the study will be 12 months., To the check the efficacy of zinc which includes urinary assessment, spot urine protein creatinine ratio, BP, 24hr urine output, fluid intake, Abdominal girth will be assessed daily, however serum electrolyte, serum protein, lipid profile, serum creatinine, serum urea will be estimated at baseline and on the day of remission. Data will be entered into Microsoft excel sheet, an analytical software will be used for doing statistical analysis. Mean ± S.D will be calculated for quantitative data. Percentage and proportion will be calculated for qualitative data. Wills test will be used to check the normality of the data. Student t-test / Mann Whitney test will be used to find out the mean difference between two groups. Chi square test will be used to find out the association between categorical data using SPSS (statistical programme for social science) version-20 software. A P- value <0.05 will be considered as statistically significant.

 
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