| 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
|
|
|
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
|
|
|
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.
|
|
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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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.gokulraju@gmail.com].
- 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.
- 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 modification. So, 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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