CTRI Number |
CTRI/2022/03/041470 [Registered on: 30/03/2022] Trial Registered Prospectively |
Last Modified On: |
28/03/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Homeopathy |
Study Design |
Single Arm Study |
Public Title of Study
|
Role Of Homoeopathic Medicine In The Management Of Kidney Stones |
Scientific Title of Study
|
Efficacy Of Homoeopathic Medicine In The Management Of Nephrolithiasis Using Homoeopathic Medical Repertory By Robin Murphy |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Suganya K M |
Designation |
Post Graduate Scholar |
Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Address |
Department of Repertory OPD Room No 2C Vinayaka Missions
Homoeopathic Medical College and Hospital NH 47 Sankari Main Road
Seeragapadi PO
Salem
TAMIL NADU 636308
India
Salem TAMIL NADU 636308 India |
Phone |
8610846809 |
Fax |
|
Email |
drsuganyamahalingam@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr J Senthil Kumar |
Designation |
Professor and Head of Department |
Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Address |
Department of Repertory OPD Room No 2C Vinayaka Missions
Homoeopathic Medical College and Hospital NH 47 Sankari Main Road
Seeragapadi PO
Salem
TAMIL NADU 636308
India
Salem TAMIL NADU 636308 India |
Phone |
9842780556 |
Fax |
|
Email |
drjsenthil@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr J Senthil Kumar |
Designation |
Professor and Head of Department |
Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Address |
Department of Repertory OPD Room No 2C Vinayaka Missions
Homoeopathic Medical College and Hospital NH 47 Sankari Main Road
Seeragapadi PO
Salem
TAMIL NADU 636308
India
TAMIL NADU 636308 India |
Phone |
9842780556 |
Fax |
|
Email |
drjsenthil@gmail.com |
|
Source of Monetary or Material Support
|
Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road
Seeragapadi PO Salem TAMIL NADU 636308 India |
|
Primary Sponsor
|
Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Address |
NH 47 Sankari Main Road Seeragapadi PO Salem TAMIL NADU
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 J Senthil Kumar |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Room No 2 C - PG
Dept of Repertory OPD
Unit Ground Floor
Hospital Block
Vinayaka Missions
Homoeopathic Medical
College and Hospital
NH 47 Sankari Main
Road Seeragapadi PO
Salem TAMIL NADU
636308 India Salem TAMIL NADU |
9842780556
drjsenthil@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee Vinayaka Missions 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: N200||Calculus of kidney, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
HOMOEOPATHIC MEDICINES |
Homoeopathic medicines are selected based on individualization. The dose is selected based on the susceptibility of the patient. Medicine is administered via oral route. Follow up is taken in every 15 days. Maximum treatment period per patient under study is 6 months |
Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
Subjects of all age groups, both sexes different socioeconomic status. Diagnostic criteria will be based on clinical presentation and USG of Abdomen.
Calculi present in both the kidney is only included. |
|
ExclusionCriteria |
Details |
Cases with calculi measuring more than 7mm.
Acute renal pain.
Calculous Pyelonephritis.
Systemic illness.
Poorly functioning kidney
Renal failure
Metabolic disorder
Congenital anomaly
Calculi present in ureter and bladder
Subjects with systemic affections of irreversible pathological changes in the body |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
BASED ON THE ULTRASONOGRAPHY OF ABDOMEN,
CLINICAL SIGNS AND SYMPTOMS OF RENAL CALCULI ARE ASSESED |
AT BASELINE AND AFTER 6 MONTHS |
|
Secondary Outcome
|
Outcome |
TimePoints |
IT IS EXPECTED THAT THE PROPOSED
STUDY WILL BE USEFUL IN REDUCING THE
SYMPTOMS OF RENAL CALCULI |
AT BASELINE AND AFTER 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)
|
11/04/2022 |
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="2" 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
|
Nephrolithiasis is one of the most common disease of urinary tract. It is becoming one of the emerging challenges in the medical field because of modern lifestyle changes, sedentary habits, unhealthy dietary plan and overweight problems. The prevalence is increasing throughout the industrialized world. It is common affecting individuals of all countries and ethnic groups. It is more common in male as compared to female. More common in whites than in black. It shows a familial predisposition. Homoeopathy is a mode of treatment which is based on individualization and its holistic approach treats effectively without adverse effect. It is more beneficial to manage nephrolithiasis of with low cost by Homoeopathic medicine as compared to other system of medicine. Robin Murphy repertory is a unique repertory, which helps a practitioner to find out the similimum on the basis of clinical as well as classical symptoms. Murphy’s concept of totality is based on clinical as well as classical homoeopathic practice. Robin Murphy repertory is more effective and most authenticated repertory in treatment of nephrolithiasis since clinical and diagnostic symptoms are available. So in my dissertation of Nephrolithiasis I have chosen Robin Murphy repertory. |