| CTRI Number |
CTRI/2026/02/104192 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Homoeopathic approach in managing bedwetting in children by using Kent Repertory |
|
Scientific Title of Study
|
Assessing the clinical importance of general rubrics from Kent Repertory in remedy selection and management of nocturnal enuresis in children |
| 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 Shreya Saxena |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department Of Homoeopathic Repertory And Case Taking State National Homoeopathic Medical College And Hospital,Viraj Khand-1,Gomti Nagar,Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8604888325 |
| Fax |
|
| Email |
drshreya123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupesh Kumar Pandey |
| Designation |
Lecturer |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department Of Homoeopathic Pharmacy State National Homoeopathic Medical College And Hospital,Viraj Khand-1, Gomti Nagar, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9455577528 |
| Fax |
|
| Email |
drrupeshkumarpandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreya Saxena |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department Of Homoeopathic Repertory And Case Taking State National Homoeopathic Medical College And Hospital, Viraj Khand-1,Gomti Nagar,Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8604888325 |
| Fax |
|
| Email |
drshreya123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out Patient Department, Department Of Homoeopathic Repertory And Case Taking State National Homoeopathic Medical College And Hospital, Viraj Khand-1, Gomti Nagar, Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Shreya Saxena |
| Address |
Department Of Homoeopathic Repertory And Case Taking State National Homoeopathic Medical College And Hospital,Viraj Khand-1, Gomti Nagar,Lucknow |
| 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 Shreya Saxena |
State National Homoeopathic Medical College And Hospital Lucknow |
OPD-3 Department Of Homoeopathic Repertory And Case Taking State National Homoeopathic Medical College And Hospital, Viraj Khand-1, Gomti Nagar, Lucknow
Lucknow
UTTAR PRADESH |
8604888325
drshreya123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of State National Homoeopathic Medical College And Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N399||Disorder of urinary system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Assessing the clinical importance of general rubrics from Kent Repertory in remedy selection and management of Nocturnal Enuresis in children |
The study intervention involves individualized homoeopathic treatment based on assessment of general rubrics from Kent Repertory in children diagnosed with nocturnal enuresis. Detailed case taking will be conducted with emphasis on mental generals, physical generals, thermal modalities, sleep, desires and aversions and other constitutional symptoms. Remedy selection will be done through repertorization using Kent Repertory and final confirmation from Materia Medica. The selected medicine will be prescribed in appropriate potency, and repetition or change of remedy or potency will be decided according to homoeopathic principles and clinical response. Follow up will be conducted at 15 day intervals throughout the study period. Outcome assessment will be performed using the Saha et al. Nocturnal Enuresis Scale a structured scoring scale assessing frequency and severity of bedwetting and associated factors. Scores will be recorded at baseline before initiation of treatment and at the end of the treatment period for evaluation of clinical improvement. Participants will not receive any other pharmacological treatment for nocturnal enuresis during the study. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient attendants who are willing for inclusion in the study and giving
consent to participate and those who are able to come for the further
follow ups.
2. Diagnostic criteria is based on clinical presentation.
3. Improvement criteria is based on NOCTURNAL ENURESIS SCORING SCALE. |
|
| ExclusionCriteria |
| Details |
1. Patient attendant unwilling for inclusion in the study and those who are
not able to come for follow ups.
2. Patients taking treatment from any other systems.
3. Patients of age below 5 years above 15 years.
4. Patients diagnosed from CKD, DM, and DI or any other disease which causes
bedwetting.
5. Children under the treatments of diuretics medicine.
6. Children suffering from congenital anomaly of urinary tract. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in nocturnal enuresis in children as assessed by change in total score on the Saha et al. Nocturnal Enuresis Scale from baseline to the end of the treatment period. |
Baseline to 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the role and clinical importance of General Rubrics from Kent Repertory in accurate remedy selection and individualized management of nocturnal enuresis in children |
Baseline to 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)
|
24/02/2026 |
| 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="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
|
Nocturnal enuresis is involuntary urination during sleep in children aged five years or older without any organic cause. Kent Repertory classifies symptoms into rubrics. General Rubrics represent the patient overall physical and mental characteristics important for individualized remedy selection. This study evaluates the clinical importance of General Rubrics in selecting homoeopathic remedies for managing nocturnal enuresis in children with improvement assessed using a standardised Saha et al nocturnal enuresis scale |