| CTRI Number |
CTRI/2025/08/092815 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Managing Knee Osteoarthritis in Women with Individualized Homeopathic treatment with medicines selected by using Boger Boenninghausens Repertory |
|
Scientific Title of Study
|
Efficacy of Individualized Homoeopathic Treatment using Boger-Boenninghausen’s Repertory in Females with Knee Osteoarthritis: A Randomized Controlled Trial. |
| 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 Anushya A |
| Designation |
Post Graduate |
| Affiliation |
Sarada Krishna Homoeopathic Medical College and Hospital |
| Address |
Room No 301 2nd Floor college building
Department of Homoeopathic Repertory and Case Taking
Sarada Krishna Homoeopathic Medical College and Hospital Kulasekharam Kanyakumari
Kanniyakumari TAMIL NADU 629161 India |
| Phone |
8939029202 |
| Fax |
|
| Email |
anush1793@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Suman Sankar AS MDHom PhD |
| Designation |
Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College and Hospital |
| Address |
Room No 301 2nd Floor
Department Of Homoeopathic Repertory and Case Taking
Sarada Krishna Homoeopathic Medical College and Hospital Kulasekharam Kanyakumari
Kanniyakumari TAMIL NADU 629161 India |
| Phone |
9443500675 |
| Fax |
|
| Email |
dissert02@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Suman Sankar AS MDHom PhD |
| Designation |
Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College and Hospital |
| Address |
Room No 301 2nd Floor college building
Department Of Homoeopathic Repertory and Case Taking
Sarada Krishna Homoeopathic Medical College and Hospital Kulasekharam Kanyakumari
Kanniyakumari TAMIL NADU 629161 India |
| Phone |
9443500675 |
| Fax |
|
| Email |
dissert02@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Anushya A Sarada Krishna Homoeopathic Medical College and Hospital |
| Address |
Room No 107
Ground floor
Sarada Krishna Homoeopathic Medical College and Hospital Kulasekharam, Kaniyakumari district 629 161
|
| 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 Anushya A |
Sarada Krishna Homoeopathic Medical College and Hospital |
Room No 107 Ground Floor
Sarada Krishna Homoeopathic Medical College and Hospital Kulasekharam Kanyakumari
Kanniyakumari TAMIL NADU |
08939029202
anush1793@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE |
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 |
| Comparator Agent |
Calcarea Flourica 6x |
Control group Receives Calcarea Flourica 6x 2 pills in the morning and 2 pills at night daily |
| Intervention |
Individualized Homeopathic Medicines |
Study Group receives homeopathic treatment selected through repertorisation based on individual symptoms
The medicine will be administered daily once every morning after food orally 30th potency 2 globules or as required based on the susceptibility of the patient
The patients will be followed every 14 days or as required and follow up treatment will be based on the symptom changes either SL or higher potency or change of medicine based on the repertorization results |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Patients with complaints of osteoarthritis of knee |
|
| ExclusionCriteria |
| Details |
Patients with arthritic chronic diseases other than osteoarthritis and surgical complications
Male patients
Patients with severe disability of osteoarthritis of knee
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness of individualized homoeopathic remedies in managing knee osteoarthritis in females as assessed by changes in clinical symptoms
Reduction in pain intensity and improvement in joint functionality measured using validated scale such as WOMAC pain scale and VAS
Improvement in quality of life evaluated through patient reported outcome measures
|
Reduction in pain intensity will be assessed for 2 MONTHS for once in 15 days
end of 2 months changes in pain will be assessed
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Identification of frequently used rubrics in the treatment of knee osteoarthritis as per Boger Boenninghausens Characteristics and Repertory BBCR
Analysis of the most commonly selected remedies based on repertorization results for knee osteoarthritis cases
|
2 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
30/08/2025 |
| 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 Applicable |
| 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
|
Osteoarthritis is the most prevalent type of musculoskeletal disorder globally and is the leading cause of chronic pain and disability in adults A survey revealed that significantly higher prevalence of arthritis in the rural 17 percentage in adult compared with the urban in tamil nadu The prevalence of osteoarthritis in kanyakumari district is 115000 adult population and women are more affected Aims to assess the clinical efficacy of individualized homoeopathic treatment prescribed according to boger boenninghausens characteristics and repertory BBCR in comparison to calcarea fluorica 6x in the management of knee OA in females Objectives compare changes in pain stiffness and physical function using the womac scale between both groups over 8 weeks evaluate patient satisfaction and quality of life during the treatment period and to identify commonly used rubrics and remedies selected through BBCR in knee OA cases Methodology two group comparative randomized control study design sampling random sampling Study group medicine selected using BBCR and control group calc flour 6x Random selection of 40 females presenting with OA from the opd ipd oa speciality clinic and phc of skhmc are taken Remedies will be prescribed based on repertorisation using BBCR Follow up assessment will be done twice a month Outcome assessment the changes before and after will be subjected to statistical analysis and presented on the basis of womac pain scale Primary outcomes effectiveness of individualized homoeopathic remedies in managing knee OA in females as assessed by changes in clinical symptoms reduction in pain intensity and improvement in joint functionality measured using validated scale such as womac pain scale improvement in quality of life evaluated through patient reported outcome measures Secondary outcomes identification of frequently used rubrics in the treatment of knee OA as per BBCR analysis of the most commonly selected remedies based on repertorization results for knee OA cases |