| CTRI Number |
CTRI/2025/09/094673 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the benefits of homeopathic medicines in bedwetting |
|
Scientific Title of Study
|
A CLINICAL TRIAL TO COMPARE THE EFFECTIVENESS OF EQUISETUM HYEMALE VS INDIVIDUALISED HOMEOPATHIC MEDICINES IN CASES OF ENURESIS IN PAEDIATRIC AGE GROUP-A PARALLEL ARM, RANDOMISED CONTROL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TUSHAR AGARWAL |
| Designation |
PG Scholar |
| Affiliation |
Dr. M.P. Khunteta Homeopathic Medical college, Hospital And Research Center |
| Address |
Department of Pediatric,
Room# 9
Plot no. 10,11,12, Saipura, Sanganer, Jaipur- 302029
Jaipur
RAJASTHAN
302029
India |
| Phone |
2364662 |
| Fax |
|
| Email |
tg3176@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Prasoon Choudhary |
| Designation |
Prof and HOD |
| Affiliation |
Dr. M.P. Khunteta Homeopathic Medical college, Hospital And Research Center |
| Address |
Department of Pediatric,
Room# 9
Plot no. 10,11,12, Saipura, Sanganer, Jaipur- 302029
Jaipur
RAJASTHAN
302029
India |
| Phone |
2364662 |
| Fax |
|
| Email |
drprasoonchoudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
TUSHAR AGARWAL |
| Designation |
PG Scholar |
| Affiliation |
Dr. M.P. Khunteta Homeopathic Medical college, Hospital And Research Center |
| Address |
Department of Pediatric,
Room# 9
Plot no. 10,11,12, Saipura, Sanganer, Jaipur- 302029
RAJASTHAN
302029
India |
| Phone |
2364662 |
| Fax |
|
| Email |
tg3176@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Madan Pratap Khunteta Homeopathic Medical College, Hospital and Research Center, Plot no 10,11,12, Saipura, Sanganer, Jaipur |
|
|
Primary Sponsor
|
| Name |
Dr. Madan Pratap Khunteta Homeopathic Medical College, Hospital and Research Center |
| Address |
Plot no. 10,11,12, Saipura, Sanganer, Jaipur- 302029 |
| Type of Sponsor |
Private 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 Prasoon Choudhary |
Dr. Girendra Pal Homeopathic Hospital |
Department of Pediatric,
Room# 9
Plot no. 10,11,12, Saipura, Sanganer, Jaipur- 302029
Jaipur
RAJASTHAN |
2364662
drprasoonchoudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
EQUISETUM HYEMALE |
EQUISETUM HYEMALE IN ALL AVAILABE POTENCIES AS WELL AS MOTHER TINCTURE |
| Comparator Agent |
INDIVIDUALISED HOMEOPATHIC MEDICINE |
INDIVIDUALISED HOMEOPATHIC MEDICINES SELECTED ON THE BASIS OF TOTALITY OF THE CASE. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Valid written Consent from parent/guardian and Assent from patient.
Primary and Secondary enuresis(Due to worm infestation, chronic constipation, UTI, Emotional problems or Sleep apnea) both shall be enrolled
|
|
| ExclusionCriteria |
| Details |
If written consent is not given
Any pathological condition or structural abnormality
Any systemic illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare the effectiveness of equisetum hyemale and individualised homeopathic medicine using pre and post scores of modified NESS scale.
|
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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="0"
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 a randomised, single blind, parallel arm control trial to compare the effectiveness of equisetum hyemale and individualised homeopathic medicine in paediatric age group in 42 patients for a period of 12 months. The primary outcome will be to compare equisetum hyemale and individualised homeopathic medicine using NESS(Nocturnal Enuresis Symptom Score). |