| CTRI Number |
CTRI/2024/05/066943 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic medicine for Nocturnal Enuresis (Bed wetting) in children |
|
Scientific Title of Study
|
Role of Individualized homoeopathic medicine in management of nocturnal enuresis in children based on Dr Kents evaluation of symptomatology An open single arm interventional study |
| 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 Abhishek Sharma |
| Designation |
Post Graduate Trainee |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department of Organon of medicine and homoeopathic philosophy
State National Homoeopathic Medical College And Hospital
Viraj Khand 1 Gomtinagar Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
7895413990 |
| Fax |
|
| Email |
theabhisheksharma@outlook.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Vijay Pushkar |
| Designation |
Principal |
| Affiliation |
State Dr Brijkishore Homoeopathic Medical College And Hospital |
| Address |
State Dr Brijkishore Homoeopathic Medical College And Hospital
Deokali Ayodhya Uttar Pradesh
Faizabad UTTAR PRADESH 224001 India |
| Phone |
9415466529 |
| Fax |
|
| Email |
Vijay04pushkar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Abhishek Sharma |
| Designation |
Post Graduate Trainee |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department of Organon of medicine and homoeopathic philosophy
State National Homoeopathic Medical College And Hospital
Viraj Khand 1 Gomtinagar Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
7895413990 |
| Fax |
|
| Email |
theabhisheksharma@outlook.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College And Hospital
Viraj Khand 1 Gomtinagar Lucknow Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Abhishek Sharma |
| Address |
State National Homoeopathic Medical College And Hospital
Viraj Khand 1 Gomtinagar Lucknow Uttar Pradesh 226010 |
| 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 Abhishek Sharma |
State National Homoeopathic Medical College And Hospital |
Department of Organon of medicine and homoeopathic philosophy
State National Homoeopathic Medical College And Hospital
Viraj Khand 1 Gomtinagar Lucknow Uttar Pradesh Lucknow UTTAR PRADESH |
7895413990
theabhisheksharma@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of State National Homoeopathic Medical College And Hospital |
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 |
Homoeopathic Individualized Medicine |
Individualized homoeopathic medicine will be prescribed after a detailed case history and repertorization with the help of reportory and potency of medicine will be determined as per individual case requirement.
|
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
(1) Patients of age between 5 to 13.
(2) Both sexes are included.
(3) Diagnostic-criteria is based on clinical presentation.
(4) Improvement-criteria is based on NOCTURNAL ENURESIS SCORING SCALE
(5) Patient’s attendant given consent to participate.
|
|
| ExclusionCriteria |
| Details |
(1) Patient of age above to 13 years.
(2) Patient diagnosed from CKD, DM & DI or any other disease which cause bed wetting.
(3) Children under the treatment of diuretics medicine.
(4) Children suffering from any congenital anomaly of urinary tract.
(5) Patient unwilling for inclusion in the study and those who are not able to come for follow-up.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nocturnal Enuresis Scoring Scale |
At baseline and after every 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nocturnal Enuresis Scoring Scale |
At baseline and after every 15 days |
|
|
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)
|
18/05/2024 |
| 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 a common and upsetting disorder that can significantly affect a child’s behaviour as well as their emotional and social lives. Parents experience more stress from it. Normal daily schedules and social activities, such as sleeping and going to school, can be disturbed. Additionally, it can lead to far more severe emotions and behaviors like, hopelessness, a lack of optimism, guilt and shame, humiliation, victimization, and a loss of self-worth. Studies on homoeopathy have demonstrated effective treatment for nocturnal enuresis. Although there are numerous homoeopathic medications recommended in the literature for the treatment of nocturnal enuresis, there is a scarcity of research supporting these claims. Therefore, the present study is undertaken to explore how Individualized homoeopathic medicine selected on the basis of Kent’s evaluation of symptomatology are useful in the treatment of nocturnal enuretic patient aged 5 to13 years. Objectives of this study will be (1) To assess the significant reduction in episodes of bed-wetting before and after the administration of Individualized homoeopathic medicine by using Nocturnal Enuresis Scoring Scale. (2) To undestand the importance of Kent’s evaluation of symptoms in homoeopathic prescription. (3) To improve mental health of children by proper counselling. Individualized homoeopathic medicine will be prescribed after a detailed case history and determine the scores from nocturnal enuresis scoring scale and repertorization with the help of reportory and potency of medicine will be determined as per individual case requirement. Each patient will be followed up every 15 days and final assessment will be done by using nocturnal enuresis scoring scale of pre and post treatment scores. |