FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078789 [Registered on: 31/12/2024] Trial Registered Prospectively
Last Modified On: 30/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Use of mung bean soap as an alternative to commercial soaps for cleansing while minimizing the topical side effects in children  
Scientific Title of Study   Utility & effectiveness of bio-active constituents of Vigna radiata to develop a cleansing agent to regulate integumental integrity in children and to compare the effects to commercially available preparations. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shalini Priya N 
Designation  Post graduate , Paediatrics  
Affiliation  Saveetha Medical College and Hospital 
Address  Department of paediatrics ,first floor, Saveetha medical college and hospital Thandalam, Kancheepuram district

Kancheepuram
TAMIL NADU
602105
India 
Phone  8056073292  
Fax    
Email  shalinipriya1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Lal D V 
Designation  Professor, Program Director Saveetha CDC, Paediatrics 
Affiliation  Saveetha Medical College and Hospital 
Address  Department of paediatrics ,first floor, Saveetha medical college and hospital Thandalam, Kancheepuram district

Kancheepuram
TAMIL NADU
602105
India 
Phone  7299938038  
Fax    
Email  drlaldv@gmail.com  
 
Details of Contact Person
Public Query  
Name  Lal D V 
Designation  Professor, Program Director Saveetha CDC, Paediatrics 
Affiliation  Saveetha Medical College and Hospital 
Address  Department of paediatrics ,first floor, Saveetha medical college and hospital Thandalam, Kancheepuram district

Kancheepuram
TAMIL NADU
602105
India 
Phone  7299938038  
Fax    
Email  drlaldv@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Kancheepuram district, Tamil Nadu 602105,India 
 
Primary Sponsor  
Name  Shalini Priya N 
Address  Saveetha medical college and hospital, Saveetha Nagar, Thandalam ,Kancheepuram district, Tamil nadu- 602105  
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 Shalini Priya N  Saveetha Medical College and Hospital   Department of Paediatrics, first floor floor, Saveetha Nagar, Thandalam
Kancheepuram
TAMIL NADU 		 8056073292

shalinipriya1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  commercially available cleansing bar  This group of children will use their regular soap thats commercially available with chemical based ingredients 
Intervention  Vigna radiata cleansing bar  Vigna radiata cleansing bar contains bio active extract of 1000 microgram per ml in one soap, incorporated in natural glycerine bar and aloe vera. The soap will be used for daily for 1 month of duration. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Paediatric population from 2- 12 years will be included the study 
 
ExclusionCriteria 
Details  1.Children below 2 years will not be included in the study.
2.Children with active source of infection will be excluded.
3.Children with pre-existing dermatological conditions will be excluded from the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
This study explores the use of bioactive extract from mung bean sprouts to address pediatric skin issues, including impetigo, hyperpigmentation, erythema multiforme, allergic reactions, and dryness. The extract is expected to support epithelial repair, protect against chemical and microbial reactions, and strengthen the skin barrier.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improve overall skin condition in children.  3 months 
 
Target Sample Size   Total Sample Size="14"
Sample Size from India="14" 
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)   15/01/2025 
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="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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 (Others) -  proposals to be directed to - shalinipriya1997@gmail.com

  6. For how long will this data be available start date provided 01-06-2025 and end date provided 31-10-2025?
    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   This study examines the use of Vigna radiata (mung bean) extract, known for its anti-inflammatory, anti-allergy, antioxidant, and antimicrobial properties, to prevent skin problems in children. The bioactive extract is added to natural glycerine soap bars for easy use. The research, conducted as a non-randomized, single-blinded, parallel-group study, focuses on repairing the skin, protecting it from harmful chemicals and microbes, and maintaining a strong skin barrier. It also promotes replacing chemical-based products with this natural alternative for daily skincare. 
Close