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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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