| CTRI Number |
CTRI/2022/05/042889 [Registered on: 27/05/2022] Trial Registered Prospectively |
| Last Modified On: |
27/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Homoeopathy in the Management of Knee Osteoarthritis |
|
Scientific Title of Study
|
Usefulness of Individualized Homoeopathic Medicines and
Pre-defined Lesser Used Remedies in the Management of
Knee Osteoarthritis: A Prospective, Comparative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meghna Bisaria |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica
Room no 218
Second Floor
Bakson Homoeopathic Medical College and Hospital
36 B Knowledge Park I
Greater Noida
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
7500516414 |
| Fax |
|
| Email |
meghnabisaria94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Nair |
| Designation |
Professor HOD and Guide |
| Affiliation |
Bakson Homoeopathic Medical College And Hospital |
| Address |
Department of Homoeopathic Materia Medica
Room no G 21
Ground Floor
Bakson Homoeopathic Medical College and Hospital
36 B Knowledge Park I
Greater Noida
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9990178024 |
| Fax |
|
| Email |
ashraj1974@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Nair |
| Designation |
Professor HOD and Guide |
| Affiliation |
Bakson Homoeopathic Medical College And Hospital |
| Address |
Department of Homoeopathic Materia Medica
Room no G 21
Ground Floor
Bakson Homoeopathic Medical College and Hospital
36 B Knowledge Park I
Greater Noida
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9990178024 |
| Fax |
|
| Email |
ashraj1974@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no G 22 Ground Floor
Bakson Homoeopathic Medical College and Hospital
36 B Knowledge Park I
Greater Noida
Uttar Pradesh |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Meghna Bisaria |
Bakson Homoeopathic Medical College and Hospital |
Out Patient Department (OPD)
Room No 1
Ground Floor
B 36
Knowledge Park I
Greater Noida
201306
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
7500516414
meghnabisaria94@gmail.com |
| Meghna Bisaria |
Dr D P Rastogi Central Research Institute of Homoeopathy |
Out Patient Department
Room No 109 and 110
Ground Floor
A-1/1 Sector 24 Noida
Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH |
7500516414
meghnabisaria94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson Homoeopathic Medical College and Hospital |
Approved |
| Kendriya Homoeopathic Anusandhan Parishad |
No Objection Certificate |
|
|
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 |
Group A: Homoeopathic Medicines
|
oral route of administration Globule form 30 pill size centesimal scale will be used follow up every 4 weeks
repetition of dose according to follow up
duration of treatment and follow ups will be 6 months |
| Intervention |
Group B: Pre defined Lesser Used Remedies
Angustura vera, Arbutus andrachne,
Salicylicum acidum ,
Formica rufa ,
Osteo-arthritic nosode |
oral route of administration Globule form 30 pill size centesimal scale will be used follow up every 4 weeks repetition of dose according to follow up
duration of treatment and follow ups will be 6 months |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient with age group of 35-69 years
2 Patients of primary stage knee osteoarthritis will be included
3 Diagnosed cases of knee osteoarthritis
4 Cases which are under the domain of American College of rheumatology (ACR) criteria, supported by X-ray as tool for investigation in case of undiagnosed cases
5 Patients with Knee OA grade 0 to grade III
6 Patient with known but controlled Systemic diseases are eligible for study
7 Patient taking prior oral or topical analgesics will be enrolled after wash out period of 5 days |
|
| ExclusionCriteria |
| Details |
1 History of knee injury
2 Cases of Knee OA of grade 4
3 Pregnant and Lactating women
4 Severe degeneration of knee joints with marked joint varus or valgus deformity of
knee evidence by imaging and requiring surgical intervention
5 Non – ambulatory patients
6 Patients with transplanted knees
7 Recent significant knee surgery within last 6 months
8 Alcohol and /or drug addiction or dependence
9 Patient on Intra- articular injection
10 Self reported joint disorder other than OA |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in KOOS Score. |
5 months for enrollment
6 months for treatment and follow ups
1 month for data analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
nil |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
01/06/2022 |
| 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
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title of the topic Usefulness of Individualized Homoeopathic Medicines and Pre defined Lesser Used Remedies in the Management of Knee Osteoarthritis A Prospective Comparative Study Aim To evaluate comparative usefulness of Individualized Homoeopathic Medicines and Pre defined Lesser Used Remedies in the management of Knee Osteoarthritis
Objective To compare the usefulness of both groups using Knee Injury and Osteoarthritis Outcome Score KOOS that incorporates pain and symptom severity physical function and quality of life elements
Sample size will be 78 to be equally distributed into 2 groups The 2 groups are Group A Individualized Homoeopathic Medicines would be prescribed (n=39) Group B Pre defined Lesser Used Remedies would be prescribed (n=39) Randomization will be done using an online computer generated randomization tool Research Randomizer Evaluation will be done based on KOOS Score. |