| CTRI Number |
CTRI/2025/03/082461 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of the Effectiveness of Symptom-Based Homeopathic Treatment vs. Pre-Selected Mother Tinctures in Kidney Stone Patients Using Pain Score |
|
Scientific Title of Study
|
A Comparative Study To Assess The Effectiveness of Homoeopathic Medicines Selected On The Basis Of The Totality Of Symptoms vis-a-vis Pre-identified Organopathic Mother Tincture In Cases Of Nephrolithiasis Using NPRS Scale |
| 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 Kumari Sulekha |
| Designation |
PG SCHOLAR |
| Affiliation |
Dr M P K Homoeopathic Medical college hospital and research centre |
| Address |
Department of organon of medicine Dr M P K Homoeopathic medical college hospital and research centre A constituent college of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
7374062333 |
| Fax |
|
| Email |
Dk166640@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shree Mohan Sharma |
| Designation |
Professor |
| Affiliation |
Dr M P K Homoeopathic Medical college hospital and research centre |
| Address |
Department of organon of medicine Dr M P K Homoeopathic medical college hospital and research centre A constituent college of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9829152756 |
| Fax |
|
| Email |
dr.shrimohansharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kumari Sulekha |
| Designation |
PG SCHOLAR |
| Affiliation |
Dr M P K Homoeopathic Medical college hospital and research centre |
| Address |
Department of organon of medicine Dr M P K Homoeopathic medical college hospital and research centre A constituent college of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
7374062333 |
| Fax |
|
| Email |
Dk166640@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Girendra Pal Homoeopathic Hospital and research centre Collegiate Hospital Of Dr M P K Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur Rajasthan 302029 |
|
|
Primary Sponsor
|
| Name |
Dr M P K Homoeopathic Medical College Hospital and Research Centre |
| Address |
10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 302029 |
| 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 Kumari Sulekha |
Dr Girendra Pal Homoeopathic Hospital and Research Centre |
Department of Organon of medicine room no 2 unit 1 Dr MPK Homoeopathic Medical
College, Hospital and
Research Centre,Homoeopathy
University, Plot no.
10,11,12 Saipura
Sanganer
Jaipur
RAJASTHAN |
7374062333
Dk166640@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine on the basis of symptom totality |
Homoeopathic medicines shall be given orally in Centesimal potency as per case and Hahnemannian guidelines given in the 5th edition of Organon of Medicine in the form of globule no 40 dose and repetition as per need of case and reassessment at the end of 3 month |
| Comparator Agent |
Preidentified Organopathic Mother tincture |
As per case and Hahnemannian guidelines given in the 5th edition of Organon of Medicine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both symptomatic and asymptomatic with radiological evidence USG of nephrolithiasis
Diagnosed cases who have taken medicines from any other system of treatment like Allopathy Ayurveda will also be consider after a wash out period of 15 days
All socioeconomic status |
|
| ExclusionCriteria |
| Details |
Patient not willing to give consent
Patient with major systemic disorder and autoimmune diseases
Cases with hydronephrosis UTI uremia acute retention of urine for more than 24 hours
Cases of staghorn calculi
Pregnant women and lactating mothers are not included |
|
|
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 |
| According to the score obtained pre and post treatment from the NPRS scale |
Pre scores will be assessed at the baseline of treatment and post scores will be assessed at the end of 12 weeks using NRS scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the reduction in size or in number of renal calcules in the cases of
nephrolithiasis using pre and post USG reports
To observe the pre and post changes in the frequency of the pain in cases of
nephrolithiasis
To assess the predominant miasma in the cases of nephrolithiasis |
12 Months |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
31/03/2025 |
| 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)
|
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 - NO
|
|
Brief Summary
|
AIM To compare the effectiveness of homoeopathic medicines in the cases of nephrolithiasis on the basis of totality of symptoms vis a vis preidentified organopathic mother tincture OBJECTIVE To compare the effectiveness of homoeopathic medicines for the pain management in
cases of nephrolithiasis on the basis of totality of symptoms vis-à-vis preidentified
organopathic mother tincture using pre and post NPRS scale To observe the reduction in size or in number of renal calculi in the cases of
nephrolithiasis using pre and post USG reports To observe the pre and post changes in the frequency of the pain in cases of
nephrolithiasis To assess the predominant miasma in the cases of nephrolithiasis. |