| CTRI Number |
CTRI/2023/05/052848 [Registered on: 18/05/2023] Trial Registered Prospectively |
| Last Modified On: |
22/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
“A COMPARATIVE STUDY TO ASSESS THE EFFECT OF ANTIDEPRESSANT AND ANTICONVULSANT MEDICATION IN PATIENTS SUFFERING FROM PRIMARY KNEE OSTEOARTHRITIS |
|
Scientific Title of Study
|
“A COMPARATIVE STUDY TO ASSESS THE EFFECT OF PREGABALIN AND DULOXETINE MEDICATION IN PATIENTS SUFFERING FROM PRIMARY 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 |
Biswadip Ghosh |
| Designation |
Associate Professor |
| Affiliation |
Department of Clinical Immunology and Rheumatology , SSKM Hospital |
| Address |
Department of Rheumatology , SSKM hospital , A.J.C bose road , Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
|
| Fax |
|
| Email |
drbiswadip@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harsh Jain |
| Designation |
Post Doctoral Trainee |
| Affiliation |
Department of Clinical Immunology and Rheumatology , SSKM Hospital |
| Address |
Department of Rheumatology , SSKM hospital , A.J.C bose road , Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
|
| Fax |
|
| Email |
harshlj26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harsh Jain |
| Designation |
Post Doctoral Trainee |
| Affiliation |
Department of Clinical Immunology and Rheumatology , SSKM Hospital |
| Address |
Department of Rheumatology , SSKM hospital , A.J.C bose road , Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
|
| Fax |
|
| Email |
harshlj26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Clinical Immunology and Rheumatology , IPGMER and SSKM hospital, A.J.C Bose road ,Kolkata |
|
|
Primary Sponsor
|
| Name |
Department of Rheumatology |
| Address |
Department of Rheumatology , SSKM hospital , A.J.C bose road , Kolkata |
| 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 |
| Harsh Jain |
IPGMER and SSKM Hospital |
Department of Rheumatology , SSKM hospital , A.J.C bose road , Kolkata
Kolkata
WEST BENGAL |
9137060192
harshlj26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| WBUHS |
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 |
| Intervention |
Duloxetine |
30mg orally , 1 tablet once daily for 6 months |
| Comparator Agent |
Placebo |
orally , 1 tablet once daily for 6 months |
| Comparator Agent |
Pregabalin |
75mg orally , 1 tablet once daily for 6 months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with American College of Rheumatology clinical and radiographic criteria of primary knee OA with evidence of inflammation (pain and swelling with decreased function).
Disease activity: WOMAC score more than 10 with radiological score of KL 2 & 3.
|
|
| ExclusionCriteria |
| Details |
Secondary arthritis.
Any Comorbidities except controlled DM , HTN , Hypothyroid , dyslipidemias
History of taking antiepileptic medication
Nonambulatory
Patients who have psychiatric disorders, including major depressive disorder
known hypersensitivity to Duloxetine / pregabalin or any of the inactive ingredients, or frequent or severe allergic reactions to multiple medications.
Pregnant or breast feeding females
Women of child-bearing potential not using highly effective contraception.
Evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ.
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
Percentage of patients with Improvement of 20 % in WOMAC and ICOAP with treatment
|
at baseline , 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation of icoap in Indian patients in comparison to womac
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "106"
Final Enrollment numbers achieved (India)="106" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the present study was to investigate the efficacy of Pregabalin and Duloxetine in reducing pain in older adults with knee OA.Primary knee OA cases are to be selected according to inclusion criteria and matched controls will be selected from family members or relatives. The patients who failed to get benefit from conventional physical and pharmacological therapy will be offered experimental therapy in this study. informed consent will be taken from the patients. Then patients will be randomly allocated for pregabalin, Duloxetine and placebo – 3 groups. They will be followed for six months. |