| CTRI Number |
CTRI/2024/05/068012 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic Treatment of Nocturnal Enuresis |
|
Scientific Title of Study
|
A Study on Therapeutic Value of Constitutional Medicine through Synthesis Repertory in the treatment of Nocturnal Enuresis of 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 Mukesh Kumar Ranjan |
| Designation |
Pg Scholar |
| Affiliation |
R.B.T.S. Govt. Homoeopathic Medical College And Hospital |
| Address |
Dept. of Homoeopathic Repertory and case Taking
Academic Block
R.B.T.S. Govt. Homoeopathic Medical College And Hospital Muzaffarpur.
Muzaffarpur
BIHAR
842002
India |
| Phone |
8210829686 |
| Fax |
|
| Email |
mkranjan06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajeev Kumar Rai |
| Designation |
Professor |
| Affiliation |
R.B.T.S. Govt. Homoeopathic Medical College And Hospital |
| Address |
Dept. of Homoeopathic Repertory and Case Taking
Academic Block
R.B.T.S. Govt. Homoeopathic Medical College And Hospital Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
8210055098 |
| Fax |
|
| Email |
drrajeevrai16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev Kumar Rai |
| Designation |
Professor |
| Affiliation |
R.B.T.S. Govt. Homoeopathic Medical College And Hospital |
| Address |
Dept. of Homoeopathic Repertory And Case Taking
Academic Block
R.B.T.S. Govt. Homoeopathic Medical College And Hospital Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
8210055098 |
| Fax |
|
| Email |
drrajeevrai16@gmail.com |
|
|
Source of Monetary or Material Support
|
| R.B.T.S. Govt. Homoeopathic Medical College And Hospital Muzaffarpur Bihar India 842002 |
|
|
Primary Sponsor
|
| Name |
Dr Mukesh Kumar Ranjan |
| Address |
R.B.T.S. Govt. Homoeopathic Medical College And Hospital Muzaffarpur Bihar India 842002 |
| 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 |
| Dr Mukesh Kumar Ranjan |
R.B.T.S. Govt. Homoeopathic Medical College And Hospital |
Hospital Building OPD 2 (Dept. of Paedia)
Muzaffarpur
BIHAR |
8210829686
mkranjan06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RBTSGHMC&H-IEC |
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 |
Constitutional Homoeopathic Medicine |
Constitutional Homoeopathic Medicine through Synthesis Repertory given orally to the patient who is suffering from Nocturnal Enuresis in 6C 30C 200C 1M 10M & LM Potency. Dose of medicine is selected according to susceptibility of patient. The patient ws called for follow-up every 15 days. |
| Comparator Agent |
Placebo |
Other group of patient take placebo. And changes will be observe every 15 days. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1)Individuals of both sexes, all religions, all socio-economic conditions aged between 5-15 years having enuresis at least ten times in a month.
2)Diagnostic criteria are mainly based on clinical presentation.
3)Patients whose parents give consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients below 5 years and above 15 years are not included in the study.
2.Patients having organic pathology, anatomical or surgical changes behind enuresis.
3.Patients suffering from systemic illness and/or life-threatening illness.
4.Patients whose parents did not give consent to participate in the study.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out whether the constitutional medicine through Synthesis Repertory have any different effect in the treatment of enuresis in children |
3 to 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To demonstrate how much patients able to improve their quality of life.
To ascertain the reliable indication of the effective medicine.
|
3 to 4 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
05/06/2024 |
| 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 Yet Recruiting |
| 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 disorder in which night time loss of bladder control, or bed-wetting usually in children.This study prospective to show how Synthesis Repertory helps in the treatment of bed wetting in children through proper individualized drug after case taking then repertorial outcome. This study helps homeopathic physician to select constitutional medicine through Synthesis Repertory. a wide range of medicine can be selected through this study. · |