| CTRI Number |
CTRI/2024/03/064800 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of Knee Joint pain using Homoeopathic Treatment |
|
Scientific Title of Study
|
A Clinical Study on the Effectiveness of LM Potency in Osteoarthrtis of Knee Joint |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thankam Ravi |
| Designation |
Pg Scholar |
| Affiliation |
The Tamil Nadu Dr.M.G.R Medical University Chennai |
| Address |
Department of Organon of Medicine
Sarada Krishna Homoeopathic Medical College and Hospital Kulsekharam
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9496491369 |
| Fax |
|
| Email |
drthankamravi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoj Narayan V |
| Designation |
Professor |
| Affiliation |
The Tamil Nadu Dr.M.G.R Medical University Chennai |
| Address |
Department of Organon of Medicine
Sarada Krishna Homoeopathic Medical College And Hospital Kulasekharam
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9995114518 |
| Fax |
|
| Email |
manojnarayanv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manoj Narayan V |
| Designation |
Professor |
| Affiliation |
SARADA KRISHNA HOMOEO MEDICAL COLLEGE AND HOSPITAL KULASEKHARAM |
| Address |
Department of Organon of Medicine
Sarada Krishna Homoeopathic Medical College And Hospital Kulasekharam
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9995114518 |
| Fax |
|
| Email |
manojnarayanv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarada Krishna Homoeopathic Medical College and Hospital Kulasekharam Kanniyakumari 629161 |
|
|
Primary Sponsor
|
| Name |
Thankam Ravi |
| Address |
Sarada Krishna Homoeopathic Medical College and Hospital Kulasekharam |
| 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 Thankam Ravi |
Sarada Krishna Homoeopathic Medical College and Hospital |
Department of Organon of Medicine
Sarada Krishna Homoeopathic Medical College and Hospital Kulasekharam
Kanniyakumari
TAMIL NADU |
9496491369
drthankamravi@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: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines in LM potency |
Individualised homoeopathic medicine will be given based on symptom similarity. Medicine will be given in LM potency which includes potencies like 0/1, 0/2, 0/3, etc. Medicine will be administered through oral route. Medicine will be given every two weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptomatology of Osteoarthritis of knee joint |
|
| ExclusionCriteria |
| Details |
Age group below 50 years and above 60 years.
Cases in which surgical intervention becomes necessary
Patients suffering from other severe systemic diseases and not suffers from any diagnostic pathology.
Pregnant women.
Patients under allopathic medication for Osteoarthritis and other diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the case of osteoarthritis will be noted accordingly. Improvement of pain of osteoarthritis is validated using WOMAC score. Pre and post test assessment are subjected to statistical analysis |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the case of osteoarthritis will be noted accordingly. Improvement of pain of osteoarthritis is validated using WOMAC score. Pre and post test assessment are subjected to statistical analysis |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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)
|
Effectiveness of LM potency in managing osteoarthritis of knee joint can be evaluated through this study. In western population it is one of the most frequent causes of pain ,loss of function and disability in adults. Radiographic evidence of OA occurs in the majority of people by 65 years of age and in about 80% of those aged over 75 years and LM potency is very effective in treatment of osteoarthritis of knee joint thus the study is taken . |