| CTRI Number |
CTRI/2022/05/042483 [Registered on: 12/05/2022] Trial Registered Prospectively |
| Last Modified On: |
10/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical study on urinary stones |
|
Scientific Title of Study
|
A Clinical Study on the Homoeopathic Management Of Urolithiasis using LM Potency |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dibigaa Vk |
| Designation |
PG Scholar |
| Affiliation |
Vinayaka Mission Homoeopathic Medical College and Hospita |
| Address |
Department of Organon of Medicine
Opd room no 2e1
Vinayaka Mission Homoeopathic Medical College and Hospital
NH47 Sankari Main Road Seeragapadi Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9489739083 |
| Fax |
|
| Email |
drdibigaavk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr E Nisha Paul |
| Designation |
Professor and Head of Department |
| Affiliation |
Vinayaka Mission Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine
Opd room no 2e1
Vinayaka Mission Homoeopathic Medical College and Hospital
NH47 Sankari Main Road Seeragapadi Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9995680275 |
| Fax |
|
| Email |
Nisha.gopal2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr E Nisha Paul |
| Designation |
Professor and Head of Department |
| Affiliation |
Vinayaka Mission Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine
Opd room no 2e1
Vinayaka Mission Homoeopathic Medical College and Hospital
NH47 Sankari Main Road Seeragapadi Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9995680275 |
| Fax |
|
| Email |
Nisha.gopal2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Mission Homoeopathic Medical College and Hospital
NH47 Sankari Main Road Seeragapadi Salem Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Vinayaka Mission Homoeopathic Medical College and Hospital |
| Address |
NH47 Sankari Main Road Seeragapadi Salem Tamilnadu 636308 India |
| 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 E Nisha Paul |
Vinayaka Mission Homoeopathic Medical College and Hospital |
Department of Organon of Medicine
Opd room no 2e1
Vinayaka Mission Homoeopathic Medical College and Hospital
NH47 Sankari Main Road Seeragapadi Salem Tamilnadu 636308 India
Salem
TAMIL NADU |
9995680275
Nisha.gopal2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee Vinayaka Mission Kirupananda Variyar Medical College And Hospital Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N22||Calculus of urinary tract in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Medicine selected based on symptom similarity and individualization using LM Potency medicine administered orally follow up is taken in every 15 days once maximum period of treatment is 6 months |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient selected from age 15 to 65 years
Patient selected from both sexes
Patient with clinical presentation of urolithiasis |
|
| ExclusionCriteria |
| Details |
Age group below 15 and above 65 excluded
Patient with gross developmental defects or structural abnormality of kidney
Patient under any other systemic diseases like cardiovascular endocrine diseases or systemic infection or on other treatment therapies
patient with kidney function impairement
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
USG abdomen and Pelvis
Urolithiasis System Score
Symptomatic improvement |
Maximum 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| USG Abdomen and Pelvis |
Maximum 6 months |
|
|
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 4 |
|
Date of First Enrollment (India)
|
15/05/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
| The Term Urolithiasis is determined as process of forming stones in the Kidney , Ureter, Bladder and Urethra ( Urinary Tract) . Urolithiasis is one of the major diseases of the urinary tract and is a major source of morbidity. The Stone formation is one of the painful urologic disorder that occur in approximately 15% of the global population and its reoccurance rates in males is 70-81% and 47-60% in females. The Rate of occurrence is three times higher in men than women because of enhancing capacity of testosterone and inhibiting capacity of oestrogen in stone formation . The Problem of stone formation is considered as a medical challenge due to its multifactorial etiology and high rate or reoccurance. Holistic approach of Homoeopathy is its uniqueness , considering whole man is diseased not only the affected parts. Detailed case taking and individualisation helps to find similimum. The selection of remedy is based upon the individualization and symptoms similarity . Mode of Cure is rapid , gentle and permanent restoration of the health . The aim of homeopathy is not only to treat Urolithiasis and also treats its underlying cause and individual susceptibility. Its prevents recurrence of stone formation . The Present study is to know the effectiveness of LM potency in management of Urolithiasis | |