FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091402 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [dietary]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effect of two nursing interventions, education and dietary modification among mothers of functional constipated preschool age children in Tapi district Gujarat.  
Scientific Title of Study   Effect of multifaceted nursing interventions on knowledge and practice of mothers regarding management of functional constipation among preschool age children in selected area of Tapi district Gujarat Randomized control 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  MS Divyaben Ranjitbhai Chaudhari 
Designation  Nursing Tutor, Phd Scholar 
Affiliation  Uka Tarsadia University 
Address  81/A, Laxmipark Society Ta:Vyara District:Tapi
Maniba Bhula Nursing college, Maliba Campus Uka Tarsadia University Tarsadi Mahuva Bardoli Road,Pin code:394350 District: Surat
Surat
GUJARAT
394650
India 
Phone  8141067704  
Fax    
Email  divya.chaudhari@utu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Rani Shetty 
Designation  Guide and Dean of Paramedical Science 
Affiliation  Uka Tarsadia University 
Address  Maniba Bhula nursing college, Maliba campus, Uka Tarsadia University, Mahuva-Bardoli Road Tarsadi, Dist:Surat
Maniba Bhula nursing college, Maliba campus, Uka Tarsadia University, Mahuva-Bardoli Road Tarsadi, Dist:Surat
Surat
GUJARAT
394350
India 
Phone  7219756506  
Fax    
Email  rani.shetty@utu.ac.in  
 
Details of Contact Person
Public Query  
Name  Ms.Tanvi Patel 
Designation  I/C Program officer of ICDS Department 
Affiliation  ICDS Department Jilla Panchayat Tapi 
Address  Block-9, Ground Floor, Jilla Seva Sadan, Panvadi Ta:Vyara District: Tapi
Block-9, Ground Floor, Jilla Seva Sadan, Panvadi Ta:Vyara District: Tapi
Surat
GUJARAT
394650
India 
Phone  02626224577  
Fax    
Email  tapiicds@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Ms Divyaben Ranjitbhai Chaudhari 
Address  Maniba Bhula Nursing College, Uka Tarsaia University,Maliba Campus, Bardoli 394350 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ms Tanvi Patel  Integrated Child Development Jilla panchayat Tapi  ICDS Department,Block-9,Ground floor, Jilla Seva sadan, Panvadi, Vyara Di:Tapi 394650
Surat
GUJARAT 		 02626-224577

tapiicds@gmail.com 
Dr Chetan Chaudhari  Mayapur PHC Tapi District   Villages under the Mayapur P.H.C block division Ta: Tapi Di: Tapi
Surat
GUJARAT 		 9879083838

chetanfeb75@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Human ethics comittee  Approved 
Integrated child Development Services Jilla Panchayat Tapi  Approved 
Maypur P.H.C Dist Tapi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Functional Constipation 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Education to mothers related to functional constipation through PPT and its share to mothers for further reference 2. dietary modification for children Fenugreek spinach puri and 1 medium size banana daily to Study group Duration:3 months   Child will receive daily 1 medium size banana(2.7gm fiber) and 3ogm of fenugreek spinach puri(14.1gm fiber) =16.8 gm of fiber daily . Total Duration: 3 months 
Comparator Agent  Education to mothers regarding functional constipation through leaflet  once only leaflet will share to mothers 
Intervention  Education to mothers related to functional constipation through leaflet to control group  leaflet shares to mothers 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  4.00 Year(s)
Gender  Both 
Details  Mothers of preschool age children with Functional constipation who will give consent for data collection
Mothers who are able to communicate in Gujarati and English.
 
 
ExclusionCriteria 
Details  Preschool age children are diagnosed with other GI disorder and like Hirschsprungs disease IBS other bowel syndrome
Children who are mentally challenged
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
After administering the interventions mothers knowledge and practice will be update and Functional constipation will reduce
 		 After interventions Knowledge will be assessed by structured knowledge questionnaire, practice will be assessed by checklist
Functional constipation will assess by ROME III Criteria so all intervention will be checked by end of the 4th weeks of months so 3 times observation will check after the intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   01/08/2025 
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="2"
Months="5"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [divya.chaudhari@utu.ac.in].

  6. For how long will this data be available start date provided 02-05-2027 and end date provided 02-05-2027?
    Response - Immediately following publication. No end date.

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

The study will help to identify prevalence  of functional constipation  in preschool age children  in Tapi district.  Fiber rich diet may reduce functional constipation.  Improved awareness regarding constipation its management among mothers and behavioral modification in children can improve the functional constipation.

 
Close