| CTRI Number |
CTRI/2024/07/069711 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Role of Homoeopathic medicine in management of Primary Osteoarthritis of Knee Joint |
|
Scientific Title of Study
|
Effectiveness of Individualised Homoeopathic medicine vs Angustura Vera in
management of Primary Osteoarthritis of Knee Joint A Double Arm Prospective
Clinical 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. Priya Gautam |
| Designation |
Junior Resident,(Department of Homoeopathic Philosophy) |
| Affiliation |
Nehru Homoeopathic Medical College And Hospital |
| Address |
Department of Homoeopathic Philosophy, Room No-110, Nehru Homoeopathic medical college and hospital, Defence colony, B- Block
South
DELHI
110024
India |
| Phone |
9818151433 |
| Fax |
|
| Email |
priyagautam2708@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BIPIN JETHANI |
| Designation |
HOD ( HOMOEOPATHIC PHILOSOPHY)) |
| Affiliation |
Nehru Homoeopathic Medical College And Hospital |
| Address |
Department of Homoeopathic Philosophy, Nehru Homoeopathic medical college and hospital, B- Block, Defence colony,New Delhi,110024.
South
DELHI
110024
India |
| Phone |
9810146343 |
| Fax |
|
| Email |
drbipin.jethani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Priya Gautam |
| Designation |
Junior Resident at Nehru Homoeopathic medical college and hospital |
| Affiliation |
Nehru Homoeopathic Medical College and hospital |
| Address |
Department of Homoeopathic Philosophy, Nehru Homoeopathic medical college and hospital, Defence colony, B- Block
South
DELHI
110024
India |
| Phone |
9818151433 |
| Fax |
|
| Email |
priyagautam2708@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nehru Homoeopathic medical college and hospital, Defence Colony, B-Block, Delhi-110024 |
|
|
Primary Sponsor
|
| Name |
Nehru Homoeopathic medical college and hospital is the primary sponsor |
| Address |
Nehru Homoeopathic Medical College and Hospital, Defence Colony ,B- BLOCK, DELHI-24 |
| Type of Sponsor |
Government 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 Priya Gautam Junior Resident at Nehru Homoeopathic Medical College and Hospital |
NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
Department of Homoeopathic Philosophy, Room No- 110, Nehru Homoeopathic medical college and hospital, Defence colony , B- Block , Delhi
South
DELHI |
9818151433
priyagautam2708@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICAL COMMITEE OF NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Homoeopathic medicine Angustura vera will be given in centesimal potency(30,200) |
40 patients will be enrolled in another arm after
allocation randomisation. Angustura vera in centesimal potency will be given after considering the severity, susceptibility, age of the patient whereas dosage will be given following the principles of homoeopathy. And follow up will be taken at every one month. |
| Intervention |
Patients will be given
individualised Homoeopathic medicine in centesimal potency after
considering totality of symptoms. |
40 patients will be enrolled for intervention. Patients will be given individualised Homoeopathic medicine in centesimal potency after
considering totality of symptoms using Bogar’s concept (HI) and follow up
of each patient will be taken at every one month. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with clinical symptoms of osteoarthritis of knee joint usingstandard American College Rheumatology guidelines.
2.Patients of either sex. |
|
| ExclusionCriteria |
| Details |
1.Patients with any other systemic disorder.
2. Patients not willing to give written consent for the study.
3.Undergoing Homeopathic treatment for any other disorder.
4.Simultaneous participation in any other clinical trial.
5. Self-reported immune-compromised state (e.g., HIV)
6.Vulnerable population – unconscious, non-ambulatory, too sick for consultation, differently abled, terminally or critically ill subjects. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To access the reduction of clinical symptoms of primary osteoarthritis
of knee joint using KOOS scale |
Baseline and at every month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the improvement in pain using VAS scale.
- To assess the effect of medicine on symptoms of patients using MYMOP2.
|
Baseline and at every month. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| 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 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 (OA) is a heterogeneous group of degenerative joint disease of multifactorial origin, characterised by defective integrity and progressive loss of articular cartilage, subchondral bone remodelling, joint space narrowing and bone spur formation, as well as synovial inflammation.
The aim of this study is to evaluate the Effectiveness of Individualized Homoeopathic (IH) medicines versus Angustura vera in the management of Primary Osteoarthritis of knee.
Primary Objective: - To access the reduction of clinical symptoms of primary osteoarthritis of knee joint using KOOS scale.
Secondary Objective: - To assess the improvement in pain using VAS scale. - To assess the effect of medicine on symptoms of patients using MYMOP2
Research question: Is there any significant difference between individualized homoeopathy (IH) and Angustura Vera in the management of knee osteoarthritis?
Hypothesis:
1. Null hypothesis (H0): There will be no difference between individualized homoeopathy (IH) and Angustura vera in the management of knee osteoarthritis 2. Alternative hypothesis (HA): There will be significant difference between individualized homoeopathy (IH) and Angustura vera in the management of knee Osteoarthritis.
Source of data: Out patient and in- patient department of Nehru Homoeopathic Medical college and hospital
Study duration: 12 months
Study design: A Double Arm, Prospective Clinical Trial
Sample size- Total 80 patients will be included in trial. 40 in HI arm and 40 in Comparator arm.
Inclusion and exclusion criteria
Inclusion criteria- Patient with clinical symptoms of osteoarthritis of knee joint using standard American College Rheumatology guidelines. Patients of either sex.
Exclusion criteria- Patients with any other systemic disorder. Patients not willing to give written consent for the study. Undergoing Homeopathic treatment for any other disorder. Simultaneous participation in any other clinical trial. Self-reported immune-compromised state (e.g., HIV) Vulnerable population – unconscious, non-ambulatory, too sick for consultation, differently abled, terminally or critically ill subjects. |