| CTRI Number |
CTRI/2024/04/065294 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic medicines in the treatment of urolithiasis |
|
Scientific Title of Study
|
Usefulness Of ‘Kidney Calculi’ As An Eliminating Rubric From Boger Boenninghausen’s Characteristics Repertory In The Management Of Urolithiasis- A Prospective Observational 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 |
Rupal Singh |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room number B14-15 basement
Department of case taking and repertory
Bakson Homoeopathic Medical College
36-B Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7982854958 |
| Fax |
|
| Email |
rupalsingh1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rupal Singh |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room number B14-15 basement
Department of case taking and repertory
Bakson Homoeopathic Medical College
36-B Knowledge Park 1
Greater Noida
UTTAR PRADESH
201310
India |
| Phone |
7982854958 |
| Fax |
|
| Email |
rupalsingh1999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Goyal |
| Designation |
HOD Professor and Guide |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room number B14-15 basement
Department of case taking and repertory
Bakson Homoeopathic Medical College
36-B Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9910797598 |
| Fax |
|
| Email |
draditigoyal19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital
36B Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
Uttar Pradesh
201310
India |
|
|
Primary Sponsor
|
| Name |
Principal Bakson Homoeopathic Medical College and Hospital |
| Address |
Room number G22 ground floor
Principal office
Bakson Homoeopathic Medical College
36B Knowledge Park 1
Greater Noida
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rupal Singh |
Bakson Homoeopathic Medical College and Hospital |
Out Patient Department
Room No 1 Ground floor
Bakson Homoeopathic Medical College and Hospital
Gautam Buddha Nagar
UTTAR PRADESH |
7982854958
rupalsingh1999@gmail.com |
| Rupal Singh |
Dr D P Rastogi Central Research Institute of Homoeopathy |
Out Patient Department (OPD)
Room number 110 ground floor
A1/1 Sector-24 Noida
Gautam Buddha Nagar
UTTAR PRADESH |
7982854958
rupalsingh1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson Homoeopathic Medical College and Hospital |
Approved |
| Kendriya Homoeopathic Anusandhan Parishad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N20||Calculus of kidney and ureter, (2) ICD-10 Condition: N21||Calculus of lower urinary tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine |
15 months study
6 months enrollment
6 months follow up
3 months analysis
oral route of administration
pill form
30 pill size
first dose after taking the case
subsequent doses after each follow up
potency according to the case |
| Comparator Agent |
NIL |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1 Participants of age group 19-59 years of both genders
2 Size of calculi 5mm-7mm
3 Cases (symptomatic/ asymptomatic) with radiological evidence X-ray/USG(KUB)of calculi in kidney/ureter/bladder
4 Participants giving consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1 Participants with moderate/severe hydronephrosis
2 Participants unwilling to participate in the study or not to undergo any investigation, if advised
3 Pregnant and lactating females
4 Participants who are bedridden or have structural kidney defect
5 Cases having staghorn calculus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected to have positive changes on USS scale |
15 months study
6 months enrollment
6 months follow up
3 months data analysis
USS scale to be used at baseline, 12 weeks and 24 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is expected to have positive changes in USG |
15 months study
6 months enrollment
6 months follow up
3 months data analysis
USG will be done at baseline and at the end of 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
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)
|
15/04/2024 |
| 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="3"
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 study is to assess the role of homoeopathic medicine in the treatment of urolithiasis Sample size is 31 Single arm study 15 months study Scale used for assessment USS scale Investigation used for assessment USG It is expected to see the positive changes in the USS scale and USG
|