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CTRI Number  CTRI/2025/03/081499 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 24/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of homoeopathic medicines in the treatment of bilateral knee osteoarthritis of post menopausal women 
Scientific Title of Study   Effectiveness of individualized homoeopathic medicines with centesimal potency in the treatment of bilateral knee osteoarthritis for post menopausal women of age group 45 to 65 years a single arm open label clinical study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanyukta Mallick 
Designation  Postgraduate trainee 
Affiliation  National Institute of Homoeopathy 
Address  National Institute of Homoeopathy Block GE Salt lake Sector 3 Kolkata 700106 West Bengal Department of Homoeopathic Materia Medica OPD Room no 18

Kolkata
WEST BENGAL
700106
India 
Phone  8250553819  
Fax    
Email  sanyuktam13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanyukta Mallick 
Designation  Postgraduate trainee 
Affiliation  National Institute of Homoeopathy 
Address  National Institute of Homoeopathy Block GE Salt lake Sector 3 Kolkata 700106 West Bengal Department of Homoeopathic Materia Medica OPD Room no 18

Kolkata
WEST BENGAL
700106
India 
Phone  8250553819  
Fax    
Email  sanyuktam13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chintamani Nayak 
Designation  Associate Professor 
Affiliation  National Institute of Homoeopathy 
Address  National Institute of Homoeopathy Block GE Salt lake Sector 3 Kolkata 700106 West Bengal Department of Homoeopathic Materia Medica OPD Room no 18

Kolkata
WEST BENGAL
700106
India 
Phone  9433161854  
Fax    
Email  drcnayak@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy Block GE Sector 3 Salt Lake Kolkata 700106 West Bengal India 
 
Primary Sponsor  
Name  Dr Sanyukta Mallick 
Address  National Institute of Homoeopathy Block GE Salt lake Sector 3 Kolkata 700106 West Bengal Department of Homoeopathic Materia Medica OPD no 18 
Type of Sponsor  Other [Self] 
 
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 Sanyukta Mallick  National Institute of Homoeopathy  National Institute of Homoeopathy Block GE Salt lake Sector 3 Kolkata 700106 West Bengal Department of Homoeopathic Materia Medica OPD no Room 18
Kolkata
WEST BENGAL 		 8250553819

sanyuktam13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of National Institute of Homoeopathy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicines with Centesimal Potency  Thorough and detailed case taking will be done and individualized homoeopathic medicines will be given in centesimal potency after the written informed consent by the patient following the eligibility criteria of the participants. WOMAC score and EQ5D5L questionnaire will be assessed at the Baseline and 6 months. Monthly follow up will be done. Outcome data will be assessed through the changes in WOMAC score and EQ5D5L questionnaire 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Female patients aged 45- 65 years who has already achieved menopause
Patients experiencing activity- related knee pain or complaints
Patients showing clinical signs and symptoms consistent with knee osteoarthritis or clinically diagnosed knee OA of post- menopausal females
Patients with osteoarthritis confirmed through radiological diagnosis
Patients who are willing to give consent
Patients who can understand either english/ hindi/ bengali language fluently 
 
ExclusionCriteria 
Details  Cases where any kind of surgical intervention of knee has been done before
Patients who are already advised to restrict their mobility
Female patients with malignant illness or other major conditions(unstable cardiovascular disorders, lung disease, dementia) that limit their ability to adhere to the recommended osteoarthritis treatment
Patients with unstable mental health or any kind of psychiatric disorder
Patients with any gross pathology or organ failure
Patients who excessively use or are dependent on drugs or alcohol
Self reported immunocompromised patients
Patients who are not willing to give consent  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
English version of Western ontario mcmaster universities arthritis index (womac)for pain  Baseline and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
EQ-5D-5L questionnaire for quality of life assessment  Baseline and 6 months 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   07/03/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Research Question is Does individualized homoeopathic medicines with centesimal potency play any significant role in the treatment of Bilateral knee osteoarthritis for post- menopausal women of age group 45- 65 years ? Null hypothesis is there is no significant changes by individualized homoeopathic medicines with centesimal potency in the treatment of Bilateral knee osteoarthritis for post- menopausal women of age group 45-65 years.  Alternative hypothesis is there is significant changes with individualized homoeopathic medicines with centesimal potency in the treatment of Bilateral knee osteoarthritis for post- menopausal women of age group 45- 65 years. Aim is to evaluate the effectiveness of individualized homoeopathic medicines with centesimal potency in the treatment of bilateral knee osteoarthritis for post- menopausal women of age group 45- 65 years focusing on symptoms reduction and quality of life improvements. Primary objective is to determine the changes in the intensity of symptoms in patients with bilateral knee osteoarthritis for post- menopausal women of age group 45- 65 years by using the Western Ontario McMaster Universities Arthritis Index (WOMAC) for pain and stiffness assessment. The secondary objective is to estimate the changes in the quality of life in patients with bilateral knee OA in post- menopausal women of age group 45- 65 years using the EQ-5D-5L questionnaire, a standardized tool for measuring health- related quality of life across five dimensions. It is open- label single arm clinical study, conducted in the OPD of National Institute of Homoeopathy, Kolkata where each case will be taken in detail, appropriate consent taken and then the patient will be enrolled. Appropriate statistical tools will be used and data analysed at the end of the study. 
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