| CTRI Number |
CTRI/2025/12/099141 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
13/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic Treatment for Constipation in Children A Randomised Placebo-Controlled Study |
|
Scientific Title of Study
|
A Randomized Placebo- Controlled trial to evaluate the effectiveness of Individalized Homeopathic Intervention in Constipation 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 Konda Sai Sharanya |
| Designation |
PG Scholor |
| Affiliation |
JIMS Homeopathic Medical College And Hospital |
| Address |
opd no 1
department of paediatrics
JIMS Homeopathic Medical College And Hospital RR Dist Telangana 509325
Hyderabad
TELANGANA
509325
India |
| Phone |
9014056167 |
| Fax |
0402470444 |
| Email |
sharu.sharanya1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A TAMIL SELVAN |
| Designation |
PROFESSOR |
| Affiliation |
JIMS Homeopathic Medical College And Hospital |
| Address |
OPD NO 1
DEPARTMENT OF PAEDIATRICS
JIMS Homeopathic Medical College And Hospital RR Dist Telangana 509325
Hyderabad
TELANGANA
509325
India |
| Phone |
8903853701 |
| Fax |
0402470444 |
| Email |
tamilselvanyuvanika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Konda Sai Sharanya |
| Designation |
PG Scholor |
| Affiliation |
JIMS Homeopathic Medical College And Hospital |
| Address |
OPD NO 1
DEPARTMENT OF PAEDIATRICS
JIMS Homeopathic Medical College And Hospital RR Dist Telangana 509325
Hyderabad
TELANGANA
509325
India |
| Phone |
9014056167 |
| Fax |
0402470444 |
| Email |
sharu.sharanya1998@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIMS Homeopathic Medical College And Hospital |
| Address |
JIMS Homeopathic Medical College And Hospital Telangana Sriramnagar Muchintal village shamshabad mandal Hyderabad 509325 Telangana 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 Konda sai sharanya |
JIMS HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
JIMS Homeopathic Medical College And Hospital Telangana Sriramnagar Muchintal village shamshabad mandal Hyderabad 509325 Telangana India
Hyderabad
TELANGANA |
8464094303
0402470444
sharu.sharanya1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECJIMS |
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 |
INDIVIDUALIZED HOMEOPATHIC MEDICINE |
AN INDIVIDUALIZED HOMEOPATHIC MEDICINE WILL BE GIVEN 4 GLOBULES SIZE 30 WITH A GAP BEFORE AND AFTER FOOD AND DRINK AND REPETITION MAY BE GIVEN BASED ON CLINICAL RESPONSE PAUSED IF IMPROVEMENT IS SEEN OR REEVALUATED IF SYMPTOMS WORSEN |
| Comparator Agent |
PLACEBO |
Placebo will be administered as 4 globules with a 0 minute gap before and after food or drink and repetition may be given based on clinical response paused if improvement is seen or reevaluated if symptoms worsen |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children of both sex 5 10 years of age suffering with constipation according to
ROME 4 criteria must have straining hard stools incomplete evacuation fewer than
three spontaneous bowel movements per week
Modified Constipation Assessment Scale total score indicating moderate
severe constipation |
|
| ExclusionCriteria |
| Details |
History of surgical intervention for gastrointestinal issues
Use of ongoing allopathic
treatment for constipation or recent use of laxatives within 2 weeks prior to
enrollment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in scores on the Modified Constipation Assessment Scale from baseline to
the end of the intervention period |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/01/2026 |
| 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 - NO
|
|
Brief Summary
|
Constipation is one of the most prevalent gastrointestinal disorders in children significantly affecting their physical comfort psychosocial well-being and overall quality of life Despite standard management strategies including dietary modification behavioral therapy and laxatives many children continue to experience persistent symptoms or recurrence prompting interest in complementary approaches This randomized single-blinded placebo controlled clinical trial aims to evaluate the effectiveness of individualized homeopathic intervention along with dietary management in children aged 5 10 years diagnosed with constipation based on ROME IV criteria A total of 72 participants will be stratified and randomly allocated into two groups Group A receiving individualized homeopathic medicine and Group B receiving placebo both with identical dietary advice Outcomes will be assessed every 21 days for six months using the Modified Constipation Assessment Scale The primary outcome measure is the change in MCAS scores from baseline to completion of the study This trial intends to generate robust clinical evidence regarding the role of individualized homeopathy as an adjunctive therapeutic modality in pediatric constipation and to address the existing research gap through a rigorous methodological design |