| CTRI Number |
CTRI/2024/09/073194 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effectiveness of Predefined Homoeopathic medicines in mother tincture vis a vis 30c potency in the management of renal calculi. |
|
Scientific Title of Study
|
Efficacy of pre-defined Homoeopathic medicines in mother tincture vis - a - vis 30c potency in the management of renal calculi - parallel arm comparative clinical 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 |
Dr Khyati Lakhani |
| Designation |
Ph.D. Scholar |
| Affiliation |
Homoeopathy University |
| Address |
Department of Organon of Medicine and Homoeopathic philosophy,
Homoeopathy University
Ph.D. and Research Cell
Saipura , Sanganer
Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9924125340 |
| Fax |
|
| Email |
drkhyatilakhani511@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Dr. A.N.Mathur |
| Designation |
Professor |
| Affiliation |
Homoeopathy University |
| Address |
Department of Organon of Medicine and Homoeopathic philosophy , Dr M P K Homeopathic Medical College,Hospital and Research Centre ,Plot no.10,11,12 ,Village Saipura,Sanganer,Jaipur,Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9660301195 |
| Fax |
|
| Email |
dranmathur@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khyati Lakhani |
| Designation |
Ph.D. Scholar |
| Affiliation |
Homoeopathy University |
| Address |
Department of Organon of Medicine and Homoeopathic philosophy,
Homoeopathy University
Ph.D. and Research Cell
Saipura , Sanganer
Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9924125340 |
| Fax |
|
| Email |
drkhyatilakhani511@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Jay Jalaram Homoeopathic Medical College and Hospital,
At and Po: Morva (Rena), Bhurakhal Road, Ta: Shahera, Dist.: Panchmahal, Gujarat 389001
|
|
|
Primary Sponsor
|
| Name |
Dr. Khyati Lakhani |
| Address |
Homoeopathy University
Ph.D and Research Cell
Saipura, Sanganer
Jaipur Rajasthan:302029
|
| Type of Sponsor |
Other [Self] |
|
|
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 Khyati Lakhani |
Jay Jalaram Homoeopathic Medical College and Hospital |
Jay Jalaram Homoeopathic Medical College and Hospital Department of Organon of Medicine and Homoeopathic Philosophy, At and Po: Morva (Rena), Bhurakhal Road, Ta: Shahera, Dist.: Panchmahal, Gujarat 389001
Panch Mahals
GUJARAT |
9924125340
drkhyatilakhani511@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, Homoeopathy University, Jaipur, Rajasthan |
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 |
| Comparator Agent |
Berberis Vulgaris, Hydrangea Arborescens, Lycopodium Clavatum, Sarsaparilla, Uva Ursi |
30c potency 3 pills three times a day oral for 6 months or till removal of the stone whichever is earlier |
| Intervention |
Berberis Vulgaris, Hydrangea Arborescens, Lycopodium Clavatum, Sarsaparilla, Uva Ursi |
mother tincture 15 drops oral three times a day for 6 months or till removal of stone whichever is earlier |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 18 to 60 years.
2. Both genders.
3. Patients giving voluntary consent for the study.
4. Stone in region of kidney, ureter, bladder or in urethra.
5. Diagnosed cases of Renal calculi on basis of USG KUB reports.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating females.
2. Staghorn renal calculi.
3. The patients having severe hydronephrosis.
4. The cases requiring emergency treatment. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Renal pain Episode |
Assessing Frequency every 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Renal stone size |
• USG KUB from 0 to 6 months after onset of the treatment or as an when required, |
| Removal of Renal stone |
•6 months after onset of treatment or till removal of stone, whichever is earlier |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
14/09/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 a parallel arm comparative clinical study to evaluate and compare the efficacy of Predefined Homoeopathic medicines (Berberis Vulgaris, Hydrangea Arborescens, Lycopodium Clavatum, Sarsaparilla, Uva Ursi) in mother tincture vis a vis 30C potency in the management of renal calculi. The primary outcome measures will be Renal pain episode assessed at every 2 weeks and renal stone size assessed at 0-6 months or as an when required by USG KUB. The secondary outcomes will be removal of renal stone which is assessed at 6 months after onset of treatment or till removal of stone, whichever is earlier by USG KUB. |