| CTRI Number |
CTRI/2025/12/098309 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment for Nighttime Bedwetting in children and adolescents |
|
Scientific Title of Study
|
Effectiveness of Indivisualized Homoeopathic Medicines using fifty millesimal potency in Nocturnal Enuresis in individuals of 5-18 years: A pre- post interventional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U111113319272 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
REJWANA KHANM |
| Designation |
Post graduate trainee |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Dept.of Homoeopathic Materia Medica,1st floor,Mahesh Bhattacharyya Homoeopathic Medical College and Hospital,Sailen Manna Sarani,Drainage Canal Road,Howrah.
Haora
WEST BENGAL
711104
India |
| Phone |
8617570672 |
| Fax |
|
| Email |
khanmrejwana786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDrMihir Kanti Biswas |
| Designation |
MD(Hom.),H.O.D of dept of Homoeopathic Materia Medica |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Dept.of Homoeopathic Materia Medica,1st floor,Mahesh Bhattacharyya Homoeopathic Medical College and Hospital,Sailen Manna Sarani,Drainage Canal Road,Howrah.
Haora
WEST BENGAL
711104
India |
| Phone |
9051236301 |
| Fax |
|
| Email |
drmkb33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfDrMihir Kanti Biswas |
| Designation |
MD(Hom.),H.O.D of dept of Homoeopathic Materia Medica |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Dept.of Homoeopathic Materia Medica,1st floor,Mahesh Bhattacharyya Homoeopathic Medical College and Hospital,Sailen Manna Sarani,Drainage Canal Road,Howrah.
Haora
WEST BENGAL
711104
India |
| Phone |
9051236301 |
| Fax |
|
| Email |
drmkb33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College and Hospital,Sailen Manna Sarani,Drainage Canal Road,Doomurjala, Howrah-711104 |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Sailen Manna Sarani, Drainage Canal Road, Doomurjala -711104 |
| 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 |
| DrRejwana Khanm |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Department of Homoeopathic materia medica(1st floor) OPD room no 1,2,3,7,8,11 of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. Sailen manna sarani (Drainage canal road), Doomurjala, Howrah 711104
Haora
WEST BENGAL |
8617570672
khanmrejwana786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee,Mahesh Bhattacharyya Homoeopathic Medical College and Hospitalo e |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N394||Other specified urinary incontinence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
All patients enrolled in the study will receive homoeopathic medicine at 4 weeks interval upto 6 months on the basis of individualization.Only fifty millesimal potency will be used.All medicines procured will be GMP certified.General management will be advised. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals of 5 to 18 years who frequently, involuntarily, empty pee onto their
clothing or into their beds. This behavior happens at least twice a week for three
months in a row.
2.For the past one month, the patient has not taken any homeopathic medications
for any other chronic illnesses.
3.Patients of both sexes and from a wide range of socioeconomic backgrounds
and religions.
4.Patients whose guardian have provided informed consent to participate in the
study. |
|
| ExclusionCriteria |
| Details |
1.Diagnosed cases of unstable psychiatric illness or other life-threatening issues
affecting quality of life.
2.Patients suffering from some other organic diseases and having Diabetes and
lower urinary tract infection.
3.Severely immune-compromised state e.g.- long continued steroid therapy as in
nephrotic syndrome.
4.Patients who are taking diuretics. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the effectiveness of individualized homoeopathic medicines using fifty millesimal potency in reducing the frequency of nocturnal enuresis in individual of 5-18 years
2. To evaluate the change in Nocturnal Enuresis Symptom Score (NESS) over the treatment period. |
The outcome will be assessed at baseline, 4 weeks interval, upto 6 months during the course of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To understand the impact on social interaction & sleep quality. |
The outcome will be assessed at the baseline, 4 weeks interval, upto 6 months during the course of treatment. |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
15/12/2025 |
| 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
|
This is an single arm interventional study that will examine the effectiveness of individualized homoeopathic medicine in the treatment of nocturnal enuresis in individuals of 5-18 years .The sample size will be 35 who will meet the inclusion criteria will receive individualized homoeopathic medicine in fifty-millesimal potency. The research process will take one year and six months and monthly follow ups of each patient or as per requirements upto six months. The main outcome involves the evaluation of reduction in episodes of bed wetting through NESS score.The research aims to study the effectiveness of individualized homoeopathic medicine in fifty millesimal potency in reducing the distress of patient suffering from nocturnal enuresis. |