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CTRI Number  CTRI/2025/12/099593 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 20/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Studying homoeopathy medicine Senna for functional Constipation in Children 
Scientific Title of Study   A Clinical Study On The Effectiveness Of Homoeopathic Medicine Senna In Treating Functional Constipaton Among Paediatric Age Group 
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 GOKULRAJU G 
Designation  Junior Resident  
Affiliation  White Memorial Homoeo Medical College 
Address  Department of Homoeopathic Paediatrics White Memorial Homoeo Medical College Attoor Veeyanoor PO Kanniyakumari
Department of Homoeopathic Paediatrics White Memorial Homoeo Medical College Attoor Veeyanoor PO Kanniyakumari
Kanniyakumari
TAMIL NADU
629177
India 
Phone  9788114080  
Fax    
Email  dr.gokulraju@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr T K NAGENDRAN  
Designation  Professor and Head Department of Paediatrics 
Affiliation  White Memorial Homoeo Medical College 
Address  Department of Homoeopathic Paediatrics White Memorial Homoeo Medical College Attoor Veeyanoor PO Kanniyakumari
Department of Homoeopathic Paediatrics White Memorial Homoeo Medical College Attoor Veeyanoor PO Kanniyakumari
Kanniyakumari
TAMIL NADU
629177
India 
Phone  8946004665  
Fax    
Email  drtkn1996@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr T K NAGENDRAN  
Designation  Professor and Head Department of Paediatrics 
Affiliation  White Memorial Homoeo Medical College 
Address  Department of Homoeopathic Paediatrics White Memorial Homoeo Medical College Attoor Veeyanoor PO Kanniyakumari
Department of Homoeopathic Paediatrics White Memorial Homoeo Medical College Attoor Veeyanoor PO Kanniyakumari
Kanniyakumari
TAMIL NADU
629177
India 
Phone  8946004665  
Fax    
Email  drtkn1996@gmail.com  
 
Source of Monetary or Material Support  
Department of Homoeopathic Paediatrics, White Memorial Homoeo Medical College, Attoor, Veeyanoor PO, Kanniyakumari, Tamilnadu, India Pin: 629177  
 
Primary Sponsor  
Name  WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL 
Address  ATTOOR, VEEYANOOR POST, KANNIYAKUMARI DISTRICT. TAMILNADU - 629177 India 
Type of Sponsor  Private 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 GOKULRAJU G  White Memorial Homoeo Medical College and Hospital   Medical College and Hospital Department of Paediatrics, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor PO, Kanniyakumari, Tamilnadu, India Pin 629177
Kanniyakumari
TAMIL NADU 
9788114080

dr.gokulraju@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL ETHICS COMMITTEE WMHMCH-EC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K590||Constipation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicine Senna  Cases will be taken in detail and recorded in the structured case sheet formulated for the study. Physical examination or lab tests may be done if necessary. Functional Constipation will be assessed through Wexner Constipation Score. Medicine Senna given in proper dose and potency according to homoeopathic principle to each patient. potency- based on susceptability of the participant, Dose- minimum dose, Route of administration- oral. Each follow up at 3 days interval.  
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Age group 6 years to 14 years of age
Both genders
Children who have experienced two or more symptoms under the ROMES IV criteria.
Cases indicated with the Homoeopathic Medicine SENNA
 
 
ExclusionCriteria 
Details  Children under medication for any other systemic diseases.
Cases which have organic etiology such as hirspruchng disease, colonic obstruction etc.
Children under 6 years and above 14 years of age.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in the cases of functional constipation will be assessed by pre and post assessment using Wexner score. Monthly follow up with before and after Wexner report sheet.
0-5 = Mild improvement
6-10 = Moderate improvement
above 11 = Marked improvement
 

6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the cases of functional constipation will be assessed by pre and post assessment using Wexner score  6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   30/01/2026 
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="0"
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 - Informed Consent Form
    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 - Proposals should be directed to [dr.gokulraju@gmail.com].

  6. For how long will this data be available start date provided 30-12-2026 and end date provided 30-12-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

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

AIMS :

To understand the efficacy of Homoeopathic medicine senna, in children with functional constipation.


BACKGROUND AND JUSTIFICATION OF STUDY:

In children, functional constipation is a major problem nowadays. Most children who goes to school develops this complaint due to unfavorable situations for using toilet. In toddlers, functional constipation develops because of improper toilet training. During this problem children get various discomfort faces in their in life. They experience difficulty in passing stool, painful defecations, sometimes bloody stool may occur. If it continues for prolong period, it leads to so many complications such as fissure, hemorrhoids, fistula etc. In previous research studies were mentioned as, only diet cannot help in treating functional constipation in children, laxative is first line treatment and plays major role in reducing the constipation along with diet modificationSo, I am doing this study for knowing how homoeopathic medicines can be effective intreating the functional constipation.


HYPOTHESIS

NULL HYPOTHESIS :

Homoeopathic medicine Senna is less effective in treating the functional constipation among paediatric age group.

ALTERNATIVE HYPOTHESIS :

Homoeopathic medicine Senna is more effective in treating functional constipation among paediatric age group.


METHODOLOGY:

A sample of 30 cases will be selected based on purposive sampling. With the patient consent, detailed case taking will be done. The patient will be screened for functional constipation using ROME’S IV criteria. After taking the case, the totality of symptoms will be obtained through the analysis and evaluation of symptoms. Physical examinations or lab tests may be done if necessary. Functional Constipation will be assessed through Wexner Constipation Score. Before intervention will be recorded by using Wexner constipation score. Homoeopathic medicine SENNA will be prescribed with the proper dose, potency, and repetition of medicines according to the Homoeopathic principles.  Medicine is known for its laxative purpose and effectively acts on patients with chronic and habitual constipation. Wexner constipation score will be assessed on every follow-up. Each follow up at 3 days interval.


 
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