| CTRI Number |
CTRI/2023/02/049493 [Registered on: 07/02/2023] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical study on knee joint pain |
|
Scientific Title of Study
|
A Clinical Study on Effectiveness of LM Potency in the Treatment of Osteoarthritis of Knee Joint by using Western Ontario and McMaster Universities Osteoarthritis Index |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gokulraj G |
| Designation |
PG scholar |
| Affiliation |
Vinayaka Mission Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine Opd room 2e1 Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main Road Seeragapadi Salem
Salem TAMIL NADU 636308 India |
| Phone |
7010095572 |
| Fax |
|
| Email |
drgokulbhms007@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 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 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 roomno 2e1 vinayaka mission homoeopathic medical college and hospital NH47 sankari main road seeragapadi salem 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: M17||Osteoarthritis of knee, |
|
|
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 30 days once maximum peroid of treatment is 6 months |
| Comparator Agent |
Not applicable |
Not appliable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The patients of both sexes are above 35 years of age >diagnosed cases of osteoarthritis of the knee based on the american college of rheumatology Criteria |
|
| ExclusionCriteria |
| Details |
Age group below 35 years and above 70 years excluded
Those suffering from any other knee pathologies
RA factor positive
Those suffering from immune-compromised disease and malignant disease
Cases with extreme deformities of knee joint |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
x ray of knee joint
WOMAC pain score index
symptomatic improvement |
maximum 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| x ray of knee joint |
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
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2023 |
| 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
|
Osteoarthritis (OA) is a chronic degenerative disorder characterized by the loss of articular cartilage, hypertrophy of bone at the margins, subchondral sclerosis, and range of biochemical and morphological alterations of the synovial membrane and joint capsule. In recent days, osteoarthritis has become one of the commonest disorders. OA is strongly associated with ageing and heavy physical occupational activity, a required livelihood for many people living in rural communities in developing countries. The prevalence rises progressively with age and it has been estimated that 45% of all people develop knee OA. In India, OA knee is the commonest joint disease affecting 22-45%. Its prevalence increases with age and generally affects women more frequently than men. Patients mostly complain of pain in both knee joints. Pathologically, osteoarthritis is a sero-negative inflammatory disorder of irreversible and destructive pathology. The holistic approach of Homoeopathy is its uniqueness, considering the 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 a rapid, gentle and permanent restoration of health. Through the LM scale, remedies can be repeated and aggravation is less marked. LM scale is effective in both palliation and cures for chronic diseases can be more rapidly. |