| CTRI Number |
CTRI/2024/12/078717 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
To assess the homeopathic medicinal effects in nocturnal enuresis with the help of repertory of homeopathic materia medica by Dr J.T.Kent |
|
Scientific Title of Study
|
To study the role of repertory of homeopathic materia medica by Dr J.T.kent in cases of nocturnal enuresis |
| 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 BANSARI NAMERA |
| Designation |
PG scholar |
| Affiliation |
Rajkot homeopathic medical college |
| Address |
Rajkot homeopathic medical college, behind jainath petrol pump,gondal road
Rajkot
GUJARAT
360002
India |
| Phone |
9227504540 |
| Fax |
|
| Email |
bansaripatel45677@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr HIRAL K TRIVEDI |
| Designation |
Assistant professor |
| Affiliation |
Rajkot homeopathic medical college, Department of Case taking and Repertory |
| Address |
Rajkot Homoeopathic Medical College, Department of case taking and Repertory, behind jainath
complex,makkam chowk, gondal road, rajkot.
Rajkot
GUJARAT
360002
India |
| Phone |
7405820224 |
| Fax |
|
| Email |
hiral.trivedi1994@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BANSARI NAMERA |
| Designation |
PG scholar |
| Affiliation |
Rajkot homeopathic medical college |
| Address |
Rajkot homeopathic medical college, behind jainath petrol pump, gondal road,rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9227504540 |
| Fax |
|
| Email |
bansaripatel45677@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot homeopathic medical college, parul university
Behind jainath petrol pump, gondal road, rajkot 360002 |
|
|
Primary Sponsor
|
| Name |
Rajkot homeopathic medical college |
| Address |
Rajkot homeopathic medical college, behind jainath complex, makkam chowk, gondal road, rajkot 360002 |
| 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 Bansari Namera |
Rajkot Homoeopathic Medical College attached with Sainath Medical College, Parul University. |
Behind jainath complex,
makkam chowk, gondal
road,rajkot.
Rajkot
GUJARAT
Rajkot
GUJARAT |
9227504540
bansaripatel45677@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research - Rajkot Homoeopathic Medical College (RHMC), Parul University, Gujarat. |
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. |
Individualized Homoeopathic
Medicine selected by Repertory of homeopathic Materia medica by Dr J.T. Kent.
Mode of administration : oral
(sublingual). Selection of
potency, dose and Repetition:
individualized medicine will be
prescribed in 30, 200, 1M,
potencies. Selection of potency,
dosage and repetition will be
done according to the
susceptibility of the patient and
principles of organon of
medicine. patient will be followed up for duration of 12 months. |
| Comparator Agent |
Nill |
Nill |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Cases having reversible pathology.
Cases having emotional cause.
Cases having urinary infection with enuresis. |
|
| ExclusionCriteria |
| Details |
Cases which having secondary infections.
Cases having congenital anomalies and anatomical defects.
Cases having disease of CNS, diabetes, spinal bifida. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
There will be some improvement in 25 cases after
prescribing Homoeopathic Medicines. |
There will be some improvement after 2 weeks of
prescribing Homoeopathic Medicines. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Significant Improvement – total stoppage of passing urine at night in bed
Moderate Improvement- decrease frequency of passing urine at bed than before
No Improvement- no change in frequency of passing urine at bed |
There will be some improvement after 2 weeks of
prescribing Homoeopathic Medicines. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
10/01/2025 |
| 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)
|
Other (Terminated) |
| 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
|
NEED FOR STUDY Nocturnal enuresis in children is the 2nd most common disorder after allergic disease. [1] The worldwide prevalence of enuresis among children aged 6-12 years is 1.4%- 28%. The prevalence in India is 7.61%-16.3%. The prevalence is highest in children aged 5-8 years & lowest in children aged 11-12 years. Nocturnal enuresis has been reported in 18.4% of children with sleep problem. [2] In conventional system of medicine, they usually give hormone like medication (desmopressin) & the anti-depressant imipramine. These medications may or may not provide relief to the patient. Disadvantage of medication is that it usually only works temporarily while you take it. There is also side effects of these medication found in children such as headache, nausea, vomiting & dizziness. [3] Here, the homoeopathic medicine can be effective in relieving enuresis as well as preventing the recurrence of it. This can happen without any side effects like in alternative medicines. Homoeopathic medicine can recover an illness in rapid, gentle and permanent manner according to aphorism 2 in organon of medicine by Dr B.K. Sarkar. For study, I have selected the Repertory of Homoeopathic Materia Medica by Dr J.T. Kent (6th American edition) revised by Dr R.P. Patel. This edition provide many corrections, so it may useful for study. In repertory, the plan followed throughout is from general to particulars. The potential of this repertory having more mental and general rubrics with many medicines. One of the important cause for nocturnal enuresis is psychological factor. So, this repertory is very useful for the treatment of it due to many mental rubrics included in mind chapter. |