| CTRI Number |
CTRI/2025/09/094538 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A comparative study to assess the effectiveness of Paraffinum and Individualized Homoeopathic medicine in constipation in children |
|
Scientific Title of Study
|
A randomized clinical trial to compare the effectiveness of paraffinum vs individualized homoeopathic medicine in constipation in pediatric 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 Pratishtha Singh Patel |
| Designation |
PG Scolar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Pediatrics Dr M P K Homoeopathic Medical College And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302039
India |
| Phone |
7985783886 |
| Fax |
|
| Email |
pratishthababi24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasoon Choudhary |
| Designation |
professor |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Pediatrics Dr M P K Homoeopathic Medical College And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9414718100 |
| Fax |
|
| Email |
drprasoonchoudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratishtha Singh Patel |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Pediatrics Dr M P K Homoeopathic Medical College And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
7985783886 |
| Fax |
|
| Email |
pratishthababi24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Pediatrics Dr Girendra Pal Homoeopathic Hospital And Research Centre Collegiate Hospital Of Dr M P K Homoeopathic Medical College And Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan302039 |
|
|
Primary Sponsor
|
| Name |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 3020229 |
| 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 Prasoon Choudhary |
Dr Girendra pal Homoeopathic Hospital and Research Centre |
Department of Pediatrics OPD Room no 9 Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College of Homoeopathy University 10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 302029
Jaipur
RAJASTHAN |
9414718100
drprasoonchoudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Homoeopathy University Jaipur |
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 |
| Comparator Agent |
Individualized Homoeopathic Medicine |
Individualized Homoeopathic Medicine shall be given orally in any potency 6c, 30c, 200c, 1M, 10M,50M and CM As per the case and Hahnemannian guidelines of Organon Of Medicine in the form of globules of 40 numbers ,Dose and Repetition as per need of the case reassessment at the end of 3 months |
| Intervention |
Paraffinum |
Homoeopathic Medicine shall be given orally in any potency 6c, 30c, 200c, 1M, 10M and CM As per the case and Hahnemannian guidelines of Organon Of Medicine in the form of globules of 40 numbers ,Dose and Repetition as per need of the case reassessment at the end of 3 months |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1 Children age 4-18 years
2 Children of both sex
3 Case of constipation ICD-10-CM K59.0
4 Valid written Consent and Assent from parent/guardian
5 Children with functional constipation as per Rome IV criteria. At least two of
the criteria below:
Two or fewer defecations in the toilet per week
At least 1 episode of fecal incontinence per week (after being toilet
trained)
History of retentive posturing or excessive voluntary stool retention
History of painful or hard bowel movements
Presence of a large fecal mass in the rectum
History of large-diameter stools that may obstruct the toilet |
|
| ExclusionCriteria |
| Details |
1Age less than 4 and more than 18
2 No consent
3 Organic causes (e.g., Hirschsprung’s)
4 Neurological disorders
4 Severe systemic illnesses |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study is expected to show the effectiveness of Paraffinum as well as individualized
homeopathic medicine in cases of functional constipation in children. as well as s expected to show a comparison of the two groups, pointing out the
difference in effectiveness in the two groups and medicines used. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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="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
|
A randomized clinical trial that aims to compare the effectiveness of Paraffinum versus individualized homeopathic medicines in treating constipation among children aged 4–18 years. The study will use the Constipation Scoring System (CSS) as an outcome tool over three months and seeks to generate evidence-based guidance for homeopathic management of pediatric constipation |