| CTRI Number |
CTRI/2025/06/089861 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Individualised Homoeopathic Medicines vs identified Homoeopathic Medicines in cases of kidney stones |
|
Scientific Title of Study
|
Effectiveness of Individualised Homoeopathic Medicines vs Pre-identified Homoeopathic Medicines in cases of Urolithiasis: A Randomized Double Arm Comparative Clinical 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 |
Dr Himani Choudhary |
| Designation |
Resident Medical Officer |
| Affiliation |
University College of Homoeopathy, Kekri,Ajmer |
| Address |
University College of Homoeopathy, Kekri,Ajmer-305404
2/45,Rajasthan Housing Board, Near Kendriya Vidhyalay , Jhunjhunu,Raj.
Jhunjhunun
RAJASTHAN
305404
India |
| Phone |
9982392386 |
| Fax |
0 |
| Email |
himanichoudhary8862@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar Meena |
| Designation |
HOD & Associate Professor , Department of Homoeopathic Pharmacy |
| Affiliation |
University College of Homoeopathy Kekri Ajmer |
| Address |
University College of Homoeopathy Kekri
Ajmeri Gate Rd Raghu colony Kekri Ajmer
Near Shiv Mandir ,Sapanda road,Kekri, Ajmer-305404
Ajmer
RAJASTHAN
305404
India |
| Phone |
9468536417 |
| Fax |
0 |
| Email |
raju.raju4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himani Choudhary |
| Designation |
Resident Medical Officer |
| Affiliation |
University College of Homoeopathy Kekri Ajmer |
| Address |
University College of Homoeopathy Kekri
Ajmeri Gate Rd Raghu colony Kekri Ajmer
2/45,Rajasthan Housing Board, Near Kendriya Vidhyalay , Jhunjhunu,Raj.
Jhunjhunun
RAJASTHAN
305404
India |
| Phone |
9982392386 |
| Fax |
0 |
| Email |
himanichoudhary8862@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Homoeopathy, Kekri,Ajmer-305404 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Himani Choudhary |
Homoeopathic Hospital of University College of Homoeopathy, Kekri & its Peripheries |
Ajmeri gate ,raghu colony , kekri 305404
Ajmer
RAJASTHAN |
9982392386
0
himanichoudhary8862@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Homoeopathy University, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N209||Urinary calculus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicines |
Individualized Homoeopathic Medicine
• Medicine selection: As per case taking of individual patient.
• Dosage & Repetition: Medicine will be given in globules & repetition will as per need of case
• Potency of medicine: 30 C, 200 C,1M
• Change of medicine: as per prognosis of the case after administration of remedy in accordance with principles of homoeopathy for second prescription.
• Procurement of medicine: The medicines will be procured from the pharmaceutical company having the Good Manufacturing Practices certificate.
|
| Comparator Agent |
Pre-identified Homoeopathic Medicines (Berberis vulgaris, Solidago, Hydrangea arborescens, Sarsaparilla, Pareira brava, Benzoicum acidum, Ocimum canum, Uva ursi, Tabacum ) |
• Medicine selection: Single medicine will be selected on basis of Location, Side and Pain modality.
• Potency of medicine: Mother Tincture
• Dosage & Repetition: 5 drops twice in water or As per need of case
• Change of medicine: if required.
• Procurement of medicine: The medicines will be procured from the pharmaceutical company having the Good Manufacturing Practices certificate.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Renal calculi less than 8 mm will be included for study.
All type of stones will be included
Patients who are giving consent for study.
|
|
| ExclusionCriteria |
| Details |
•Females who want to concieve, are pregnant or lactating.
•Known cases of Diabetes, Hypertension & life thereatening conditions like Cancer, Autoimmune Disorders like Rheumatoid Arthritis etc.
•Patient pursuing other treatment of urolithiasis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
o assess the effectiveness of Individualized homoeopathic medicine and Pre-identified Homoeopathic Medicines in the management of Pain in cases of urolithiasis on the basis of Pre- post scores of Pain Visual analog scale.
• To compare the size of renal calculi among 2 groups (Individualized homoeopathic medicine and Pre-identified homoeopathic medicines) assessed with USG –KUB in the management of Urolithiasis.
• To assess the predominant miasm in cases of Urolithiasis
|
a period of 18 months out of which 12 months data collection and cases will be followed up for 6 months or till removal of stone |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
11/07/2025 |
| 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="6"
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
|
Urolithiasis is a formation of stone in the kidneys ureter bladder or urethra. Urolithiasis can have serious health consequences such as severe colicky pain obstructive uropathy, infection hypertension and renal failure. Urolithiasis is associated with high medical expenditure.In India the stones belt comprises of parts of Gujarat Rajasthan Maharashtra Punjab Haryana Delhi and states of north-east. Some clinical trials and observational studies indicate that specific homoeopathic treatments can contribute to the reduction in the size of kidney stones and facilitate their expulsion from the urinary tract. Studies show that both individualised remedies as well as Organ remedies, are useful in treating urolithiasis. Homoeopathy’s individualized treatment approach, which considers the patient’s overall physical and mental state may lead to better patient outcomes. |