| CTRI Number |
CTRI/2024/02/063331 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Verifying the Rubric Knee Pain in Synthesis Repertory for understanding Osteoarthritis |
|
Scientific Title of Study
|
CLINICAL VALIDATION OF THE RUBRIC KNEE PAIN IN SYNTHESIS
REPERTORY IN THE CASES OF OSTEOARTHRITIS |
| 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 Nigel RS |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic medical college |
| Address |
Sarada Krishna Homoeopathic medical college Kulasekharam Kanyakumari district Department of Repertory 2nd floor Room number 301
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9746660531 |
| Fax |
|
| Email |
drnigelrs3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Sankar AS |
| Designation |
Professor, Department of Repertory |
| Affiliation |
Sarada Krishna Homoeopathic medical college |
| Address |
Sarada Krishna Homoeopathic medical college Kulasekharam Kanyakumari district Department of Repertory 2nd floor Room number 301
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443500675 |
| Fax |
|
| Email |
dissert02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nigel RS |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic medical college |
| Address |
Sarada Krishna Homoeopathic medical college Kulasekharam Kanyakumari district Department of Repertory 2nd floor Room number 301
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9746660531 |
| Fax |
|
| Email |
drnigelrs3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarada Krishna Homoeopathic medical college Kulasekharam Kanyakumari district Department of Repertory 2nd floor Room number 301
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nigel RS |
Sarada Krishna Homoeopathic medical college |
Kulasekharam Kanyakumari district Department of Repertory 2nd floor Room number 301
Kanniyakumari
TAMIL NADU |
9746660531
drnigelrs3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines |
The selection of medicines is done through proper case-taking and repertorization. Their administration follows homoeopathic principles, starting from the 30th potency. The frequency is at bedtime (HS), using the oral route of administration, with an intervention duration of two weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with osteoarthritis of knee.
Age between 40 and 70 years.
Both sexes
|
|
| ExclusionCriteria |
| Details |
Patients with auto-immune disease and other systemic illnesses.
Patient on other medication.
History of knee surgery within the last six months
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
The frequency of indication of the rubric “Knee pain†and its sub-rubrics from
Synthesis repertory in case of osteoarthritis will be clinically assessed.
|
Medicine given will be observed for 2 weeks consecutively for 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in pain characteristics will be assessed using WOMAC scale. |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
04/03/2024 |
| 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 is a non-inflammatory heterogeneous group of degenerative joint disease seen
mainly in older persons, characterized by degeneration of the articular cartilage, hypertrophy
of bone at the margins, and changes in the synovial membrane. Pain around the knee joint is a
frequent symptom of osteoarthritis of knee joint. Pain can be continuous or irregular which can
differ in its degree. Osteoarthritis is the second most common rheumatologic problem and it is
the most frequent joint disease with a prevalence of 22% to 39% in India. Osteoarthritis is more
common in women than men, but the prevalence increases dramatically with age. |