| CTRI Number |
CTRI/2025/03/082744 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Homoeopathy in Enuresis |
|
Scientific Title of Study
|
The effectiveness of Individualized Homoeopathic Medicines in Changing the Quality of Life in Enuresis Patients of Paediatric Age Group Using Centesimal Potencies |
| 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 HAGE AMPI |
| Designation |
PGT Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD Room No.32,Department of Paediatrics,Natonal Institute of Homoeopathy,Block GE,
Sector-3,Saltlake,
Kolkata
WEST BENGAL
700106
India |
| Phone |
09774125084 |
| Fax |
|
| Email |
drhampiofficial@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr kalasapakam Vijay Ananth |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD Room No.32,Department of Paediatrics,Natonal Institute of Homoeopathy,Block GE,
Sector-3,Saltlake,
Kolkata
WEST BENGAL
700106
India |
| Phone |
9748206295 |
| Fax |
|
| Email |
vjananth74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr kalasapakam Vijay Ananth |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD Room No.32,Department of Paediatrics,Natonal Institute of Homoeopathy,Block GE,
Sector-3,Saltlake,
Kolkata
WEST BENGAL
700106
India |
| Phone |
9748206295 |
| Fax |
|
| Email |
vjananth74@gmail.com |
|
|
Source of Monetary or Material Support
|
| Natonal Institute of Homoeopathy,Block GE,
Sector-3,Saltlake,Kolkata,
West BENGAL,700106,India |
|
|
Primary Sponsor
|
| Name |
Natonal Institute of Homoeopathy |
| Address |
Natonal Institute of Homoeopathy,Block GE, Sector-3,Saltlake,Kolkata, West BENGAL,700106,India |
| Type of Sponsor |
Government 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 Hage Ampi |
National Institude of Homoeopathy |
OPD ROOM NO.32,Department of Paediatrics
National Institude of Homoeopathy,Block GE,Sector-3,saltlake,kolkata,
Kolkata
WEST BENGAL |
09774125084
drhampiofficial@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institude of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F980||Enuresis not due to a substance orknown physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individulized Homoeopathic Medicines |
Indicated individualized homoeopathic medicines will be prescribed on the basis of totality of symptoms and if necessary then with the help of repertory. Dose and frequency of the selected medicines will be as per the susceptibility of the case. Follow up will be done monthly as per necessary. Assessment will be done on baseline and after 2nd month and 4th month respectively. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients belonging to age group between 5 - 17 years.
2) All gender.
3) Patients satisfying the DSM - V.
4) Patients who are willing to give written consent to participate in the study and giving verbal assent and written consent (child participants aged 5 -17years). |
|
| ExclusionCriteria |
| Details |
1) Patients suffering from major complications and comorbidities.
2) Suffering from complicated enuresis by secondary infection etc.
3) Children on active treatment from other system of medicine.
4) Psychological unstable patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life by (Pin Q)questionnaire scale |
Baseline and 4th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Naranjo Criteria for Homoeopathy (Monarch) |
4th month |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
22/04/2025 |
| 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="6"
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
|
|