| CTRI Number |
CTRI/2024/02/063112 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathy in Renal Stone |
|
Scientific Title of Study
|
Efficacy of Homoeopathic medical repertory by Dr. Robin Murphy in cases of Urolithiasis a single blind clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hiral kashyapbhai Trivedi |
| Designation |
PhD scholar |
| Affiliation |
Rajkot Homoeopathic medical College |
| Address |
Department of Case Taking and Repertory, Rajkot Homoeopathic medical College, behind jainath complex, makkam chowk, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
7405820224 |
| Fax |
|
| Email |
hiral.trivedi1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jignesh Patel |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Homoeopathic medical College |
| Address |
Department of case taking and repertory,Jawaharlal Nehru Homoeopathic medical College, Parul University, Limda, Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9909949221 |
| Fax |
|
| Email |
Jhpatel2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hiral kashyapbhai Trivedi |
| Designation |
PG scholar |
| Affiliation |
Rajkot Homoeopathic medical College |
| Address |
Department of Case Taking and Repertory, Rajkot Homoeopathic medical College, behind jainath complex, makkam chowk, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
7405820224 |
| Fax |
|
| Email |
hiral.trivedi1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic medical College |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic medical College |
| Address |
Rajkot Homoeopathic medical College, behind jainath complex, makkam chowk, Rajkot |
| 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 Hiral Kashyapbhai Trivedi |
Sainath homoeopathic hospital |
Room no: 102, Department of Surgery, Rajkot Homoeopathic medical College, behind jainath complex, makkam chowk, Rajkot
Rajkot
GUJARAT |
7405820224
hiral.trivedi1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research -Rajkot homoeopathic medical College (RHMC), Parul University, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N20-N23||Urolithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines selected with the help of Robin Murphy Repertory |
Individualised, selection of medicine and dosage, instructions will be strictly following the Homoeopathic principles. Each dose will be directed to be taken orally on clean tongue with empty stomach |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pre diagnosed cases of Urolithiasis or new cases having symptoms of Urolithiasis
The cases of Urolithiasis according to their symptomatology with correlation to investigate will be included
Cases with functional change or with irreversible pathology |
|
| ExclusionCriteria |
| Details |
The cases with acute emergency, congenital anomaly, systemic illness and severe irreversible pathological changes.
The cases with staghorn calculi and huge stone greater than 20mm
Patient with Urolithiasis on therapeutic measures of other disciplinary system |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Urolithiasis symptoms score before and after treatment |
beginning and end of treatment-monthly follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Homoeopathic medical repertory by Dr Robin Murphy in Homoeopathic management of Urolithiasis with the help of USS scale |
Beginning and end of treatment, 12 months |
|
|
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 |
|
Date of First Enrollment (India)
|
04/03/2024 |
| 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 - NO
|
Brief Summary
Modification(s)
|
In modern medicine, urolithiasis is managed with conservative and surgical measures, which gives temporary relief and sometimes leads to side effects. Recent decades have witnessed great advances in surgical treatment of urinary stones. But following extracorporeal shockwave lithotripsy (ESWL) about 63-85 % of acute renal injury may be noticed in patients as demonstrated by CT scan and MRI. Recurrence of the diseases, incomplete cure, with side effects and expensive treatment of the conventional medical science needs an alternative therapy such as homoeopathy for treatment of urolithiasis, which is cost-effective, gentle, safe and risk-free and has been demonstrated to be effective both in removing the stone as well as significantly decreasing recurrence. So surgery may be avoided in most of cases through homoeopathic interventions and lifestyle changes. It is a common belief in the conventional system in medical science that stones greater than 7 mm usually need to be removed surgically. Surgical intervention is not always mandatory, because there is evidence-based documentations are available where homoeopathy act marvelously in dissolution and expulsion of bigger stones. |