| CTRI Number |
CTRI/2025/09/095390 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to find out whether real homoeoapthic treatment works better than a placebo in reducing pain and improving movement in people with knee osteoarthritis |
|
Scientific Title of Study
|
A Randomised Placebo Controlled Clinical Trial To Assess The Efficacy Of Individualised Homoeopathic Medicine Versus Placebo In The Management Of Knee Osteoarthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shreya |
| Designation |
PG Scholar |
| Affiliation |
Homoeopathy University |
| Address |
Department of Materia Medica Dr. MPK Homoeopathic Medical college, Hospital and Research Centre A Constituent college of Homoeopathy University Saipura, Sanganer, Jaipur
New Station Road, Bhotika ki kothi k samne, Fatehpur Shekhawati, Sikar, Rajasthan
Sikar
RAJASTHAN
302029
India |
| Phone |
9351113534 |
| Fax |
|
| Email |
shreyakaushik226@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Sharma |
| Designation |
Associate Professor |
| Affiliation |
Homoeopathy University |
| Address |
Department of Materia Medica Dr. MPK Homoeopathic Medical college, Hospital and Research Centre.
A Constituent college of Homoeopathy University Sanganer, Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9785835468 |
| Fax |
|
| Email |
jyotisharmasky11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreya |
| Designation |
PG Scholar |
| Affiliation |
Homoeopathy University |
| Address |
Department of Materia Medica Dr. MPK Homoeopathic Medical college, Hospital and Research Centre,A Constituent college of Homoeopathy Univeristy Sanganer, Jaipur
New Station Road, Bhotika ki kothi k samne, Fatehpur Shekhawati, Sikar, Rajasthan
Sikar
RAJASTHAN
302029
India |
| Phone |
09351113534 |
| Fax |
|
| Email |
shreyakaushik226@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Materia Medica Dr Girendra Pal Homoeopathic Hopital and Research Centre Collegiate Hospital of Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur Rajasthan 302029 |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
10 11 12 Ward no 36 Saipura Sanganer Jaipur Rajasthan 302029 |
| 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 Shreya |
Dr. Girendra Pal Homoeopathic Hospital and Research Centre |
Department of Materia Medica OPD Room no 4 Dr. MPK Homoeopathic Medical college, Hospital and Research Centre A Constituent College of Homoeopathy University 10 11 12 Ward no 36 Saipura Sanganer Jaipur 302029
Sikar
RAJASTHAN |
09351113534
shreyakaushik226@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , Homoeopathy University Jiapur |
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 |
Individualised Homoeopathic Medicine |
Individualised Homoeopathic Medicine shall be given orally in any potency 6c, 30c, 200c, 1M, 10M, CM as per the case and Hahnemannian guidelines in the form of globules of 30 number, dose and repetition as per need of the case reassessment at the end of 3 month |
| Comparator Agent |
Placebo |
Placebo shall be given orally in the form of globules of 30 number dose and repetition as per need of case |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical and/or known cases of osteoarthritis.
Patient with variation in X-RAY finding .
Patients presenting with crepitus, osteophytes, restricted range of motion (ROM) and
joint tenderness on clinical examination will be recruited for the study.
Patient who are willing to give consent |
|
| ExclusionCriteria |
| Details |
Cases with any severe systemic disorders. Other joint disorders e.g. Rheumatoid arthritis, Gout , and Autoimmune disorders,etc. Any malignancy or history of malignant tumors. Severe joint deformity or surgical required. Patient who require immediateor emergency medical/surgical care. Pregnant females and lactating females will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| According to scores obtained(pre and post treatment) from the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score) and Visual Analogue Scale (VAS score). |
Pre scores will be taken at baseline of treatment and post scores will be assessed at the end of 12 weeks using WOMAC and VAS Scores. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Individualised Homoeopathic Medcine selected will be effective in managing the cases of knee osteoarthritis . It is expected that Individualised Homoeopathic Medicine will improve the frequency and intensity of knee osteoarthritis and improve quality of life of patient. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/10/2025 |
| 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="0"
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
|
AIM - To assess the efficacy of individualised Homeopathic Medicine in
management of Knee Osteoarthritis. OBJECTIVE - To assess the efficacy of individualised Homeopathic medicine by
comparing pre and post WOMAC Score in symptom management of Knee
Osteoarthritis. - To assess the efficacy of Individualised Homoeopathic medicine by comparing pre
and post VAS Score in pain management of Knee Osteoarthritis. |