| CTRI Number |
CTRI/2025/09/093988 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How the repertory section of the book Homeopathy and Child Care can help in treating bedwetting (Nocturnal Enuresis) in children |
|
Scientific Title of Study
|
A Single Arm Interventional Study: Evaluation Of Utility Of Repertory Section Of Book Homeopathy And Child Care By Dr. Shashi Kant Tiwari In Treating Cases Of Nocturnal Enuresis |
| 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 Meera Shah |
| Designation |
Professor, Head of Department, Homeopathic Repertory And Case Taking |
| Affiliation |
Dr V H Dave Homoeopathic Medical College |
| Address |
Room no 4, Department of Medicine, Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat
Anand
GUJARAT
388001
India |
| Phone |
9898692003 |
| Fax |
|
| Email |
dr.meerashah@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meera Shah |
| Designation |
Professor, Head of Department, Homeopathic Repertory And Case Taking |
| Affiliation |
Dr V H Dave Homoeopathic Medical College |
| Address |
Room no 4, Department of Medicine, Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat
Anand
GUJARAT
388001
India |
| Phone |
9898692003 |
| Fax |
|
| Email |
dr.meerashah@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rinku Makwana |
| Designation |
PG SCHOLAR |
| Affiliation |
Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital |
| Address |
Room no 4, Department of Medicine, Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat
Anand
GUJARAT
388239
India |
| Phone |
8238983010 |
| Fax |
|
| Email |
rinkumakwana3010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Rinku Makwana |
| Address |
E 8 BY 3 Wanakbori Thermal Power Station colony, Thermal, Kuni. Ta. Galteshwar, dist. Kheda, Pin Code 388239 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rinku Makwana |
SMT. S. I. PATEL (I) HOMOEOPATHIC HOSPITAL |
Department Of Medicine, Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat
Anand
GUJARAT |
8238983010
rinkumakwana3010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee VHDHMC |
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 |
Individual Homeopathic Medicine |
The medicine will be prescribed after doing repertorization with total addition process with the help of Homeopathy and Child Care and final choice will be made with the help of Homeopathic Materia Medica.The potencies 6C, 30C, 200C and 1M will be selected depending upon the susceptibility of the patient. Medicine will be given with oral route of treatment and remedy will be repeated as per the requirement of case. The duration of study is of 9 months |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients of all religion and socio-economic statuses.
Children having Nocturnal Enuresis, irrespective of primary or secondary type were included. |
|
| ExclusionCriteria |
| Details |
Cases with any congenital anomalies or irreversible pathologies will be excluded from the study, i.e. Atonic bladder, Patent Ductus Urachus. NESS score ranges from 0-7 are excluded from study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NOCTURNAL ENURESIS SYMPTOM SCORE(NESS) Scoring System |
At the baseline and at each follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 3 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="0"
Months="9"
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
|
Nocturnal enuresis is a frequent pediatric problem with notable psychosocial impact, yet often underreported and inadequately treated. Conventional options like desmopressin, alarms, and behavioral therapy face issues of relapse, side effects, and poor compliance, highlighting the need for safer, child-friendly alternatives.Homeopathy, with its individualized and gentle approach, holds promise in such functional disorders. This study evaluates the practical utility of the repertory section in Homeopathy and Child Care by Dr. Shashikant Tiwari, a source tailored for pediatric conditions but rarely tested in real practice. Using the Nocturnal Enuresis Symptom Score (NESS) as an assessment tool, symptom scores before and after treatment will be compared in Microsoft Excel, with percentage improvement calculated from baseline.Statistical significance of outcomes will be analyzed through a paired t-test. By exploring whether a focused repertory can offer effective, time-efficient prescriptions in clinical settings, this study aims to provide evidence for homeopathy as a safe, practical, and educationally valuable approach in managing nocturnal enuresis in children. |