| CTRI Number |
CTRI/2024/06/069123 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to evaluate the role of urine pH in Urolithiasis |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Role Of Urine pH In Urolithiasis Treated With Homoeopathic Medicines |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
J JOSTEL JENSHINI |
| Designation |
Pg Scholar |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Practice Of Medicine,White Memorial Homoeo Medical College and Hospital,Attoor ,veeyanoor(PO), kk district ,Tamilnadu
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9345862551 |
| Fax |
|
| Email |
josteljenshini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
J JOSTEL JENSHINI |
| Designation |
Pg Scholar |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department Of Practice Of Medicine,White Memorial Homoeo Medical College and Hospital,Attoor, veeyanoor(PO) ,kk district ,Tamilnadu
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9345862551 |
| Fax |
|
| Email |
josteljenshini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
J JOSTEL JENSHINI |
| Designation |
Pg Scholar |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department Of Practice Of Medicine,White Memorial Homoeo Medical College and Hospital,Attoor, veeyanoor(PO) ,kk district, Tamilnadu
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9345862551 |
| Fax |
|
| Email |
josteljenshini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of practice of medicine, White Memorial Homoeo Medical College and Hospital, Attoor,Kanniyakumari, Tamilnadu, India,629177 |
|
|
Primary Sponsor
|
| Name |
White Memorial Homoeo Medical College and Hospital |
| Address |
White Memorial Homoeo Medical College and Hospital Attoor veeyanoor (PO) kk district Tamilnadu, India,629177 |
| 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 J JOSTEL JENSHINI |
White Memorial Homoeo Medical College and Hospital |
Department of Practice of Medicine OPD unit, IPD unit, Health camps and Peripheral centers, Kanniyakumari, Tamilnadu
Kanniyakumari
TAMIL NADU |
9345862551
josteljenshini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee White Memorial Homoeo Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine |
Each case will be reviewed at 2-3 weeks intervals or as per their need in case of emergency, and it will be followed up for a period of 6 months |
| Intervention |
Homoeopathic medicine |
Homoeopathic medicines selected based on symptom similarity will be administrated to the patients in the proper dose, potency, and repetition of medicines according to Homoeopathic principles. |
| Intervention |
Homoeopathic medicine |
potency- based on susceptability of the participant, Dose- minimum dose, Route of administration- oral |
| Intervention |
Homoeopathic medicine |
Signs and symptoms of Urolithiasis will be assessed by Urolithiasis symptom score.
Urine pH will be assessed by urine pH scale at each follow up |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with alteration in urine ph
Patients with diagnosed urinary calculi
Subjects of both sexes.
Age group from 20-60 years.
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Patients with known serious systemic illness.
Age less than 20 and more than 60.
Patients with Diabetes Ketoacidosis, Urinary tract infection and other kidney related disorders.
Patients under medications.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Basis of score obtained from USS Chart
According to intensity cases were grouped into mild (1-7) , moderate (8-14) and severe (15-22) |
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| After completion of study Urolithiasis symptom score and urine ph will be done |
1 year |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/06/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - All the data to be provided when needed through email josteljenshini@gmail.com
- For how long will this data be available start date provided 02-03-2026 and end date provided 03-03-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A Clinical study to evaluate the role of urine pH in Urolithiasis treated with homeopathic medicines: The positive outcome of this study will prevent further recurrence of stone formation. Patients can use this treatment safely and also can overcome the side effects of conventional treatments. The cost-effectiveness of Homoeopathic treatment will help them to reduce the burden on family and society |