| CTRI Number |
CTRI/2024/04/066303 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Homoeopathic Medicines in Pain Management of Knee Osteoarthritis |
|
Scientific Title of Study
|
Homoeopathic individualized fifty millesimal potencies vis-Ã -vis centesimal potencies for pain management of knee osteoarthritis: a comparative prospective randomized 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 Siddhi Jain |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Organon Of Medicine Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
7339866102 |
| Fax |
|
| Email |
siddhi.chawat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheena Pal |
| Designation |
Assistant Professor |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Organon Of Medicine Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9772124511 |
| Fax |
|
| Email |
pal.drsheena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddhi Jain |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Organon Of Medicine Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
7339866102 |
| Fax |
|
| Email |
siddhi.chawat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Organon Of Medicine Dr Girendra Pal Homoeopathic Hospital And Research Centre Collegiate Hospital Of Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura, Sanganer, Jaipur, Rajasthan, 302029 |
|
|
Primary Sponsor
|
| Name |
Dr M P K 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 Siddhi Jain |
Dr Girendra Pal Homoeopathic Hospital And Research Centre |
Department Of Organon Of Medicine OPD Room No 2 Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University 10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 302029
Jaipur
RAJASTHAN |
7339866102
siddhi.chawat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Homoeopathy University Jaipur |
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 |
Individualised Homoeopathic Medicine In Centesimal Potency |
Homoeopathic Medicine shall be given orally in Centesimal Potency as per the case and Hahnemannian guidelines given in 5th edition of Organon of Medicine in the form of globules of 40 number, Dose and Repetition as per need of the case and reassessment at the end of 3 month |
| Intervention |
Individualised Homoeopathic Medicine In Fifty Millesimal Potency |
Homoeopathic Medicine shall be given orally in Fifty Millesimal Potency as per the case and Hahnemannian guidelines given in 6th edition of Organon of Medicine in the form of liquid, Dose and Repetition as per need of the case and reassessment at the end of 3 month |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Cases with Radiological evidence of knee of osteoarthritis with or without serological evidence
Patients giving voluntary informed consent for the study
ICD 10 CM Diagnosis Code M17.9 |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Arthritis related to auto- immune diseases i.e. Psoriatic arthritis, Rheumatoid arthritis
Grade-IV of knee OA
|
|
|
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 the scores obtained (pre and post treatment and post post treatment) from the Knee Injury and Osteoarthritis Outcome Score (KOOS)
|
Pre score will be taken at baseline of treatment and post score will assessed at the end of 12 weeks using Knee Injury and Osteoarthritis Outcome Score (KOOS)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is anticipated that the homoeopathic medicines in fifty-millesimal potency and centesimal potency will benefit the cases of knee OA Patients are expected to have a considerable relief from homoeopathic intervention and improved quality of life
The study will help to understand the relative beneficial effect of homoeopathic medicines in fifty millesimal potency and centesimal potency |
12 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
14/05/2024 |
| 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 effectiveness of homoeopathic medicines in fifty millesimal potencies vis-Ã -vis centesimal potencies for pain management in cases of knee osteoarthritis
Objectives-To assess the effectiveness of homoeopathic medicine in fifty millesimal potencies in the cases of
KNEE OSTEOARTHRITIS using KNEE INJURY AND OSTEOARTHRITIS OUTCOME
SCORE (KOOS) SCALE To assess the effectiveness of homoeopathic medicine in centesimal potencies in the cases of
KNEE OSTEOARTHRITIS using KNEE INJURY AND OSTEOARTHRITIS OUTCOME
SCORE (KOOS) SCALE To compare the effectiveness of homoeopathic medicines in fifty millesimal vs centesimal
potencies in the cases of KNEE OSTEOARTHRITIS using Knee injury and Osteoarthritis
Outcome Score (KOOS) scale To assess the predominant miasm in cases of KNEE OSTEOARTHRITIS |