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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2013/03/003442 |
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Date of registration:
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01-03-2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A clinical trial to study the effect of etodolac alone in comparison with combination of etodolac and eperisone in patients of osteoarthritis of knee joint.
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Scientific title:
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A pragmatic study of etodolac in comparison with combination of etodolac and eperisone hydrochloride- An open trial in patients of osteoarthritis of knee joint. |
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Date of first enrolment:
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04-01-2011 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5460 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
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Phase:
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Phase 4
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Countries of recruitment
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India
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Contacts
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Name:
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Harinder Singh
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Address:
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Department of Pharmacology
Government Medical College and Rajindra Hospital, Patiala.
147001
Patiala, PUNJAB
India |
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Telephone:
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Email:
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harinder390@gmail.com |
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Affiliation:
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Government Medical College and Rajindra Hospital, Patiala |
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Name:
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Navjot kaur
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Address:
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Department of Pharmacology
Government Medical College and Rajindra Hospital, Patiala.
147001
Patiala, PUNJAB
India |
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Telephone:
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Email:
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harinder390@gmail.com |
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Affiliation:
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Government Medical College and Rajindra Hospital, Patiala |
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Key inclusion & exclusion criteria
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Inclusion criteria: Confirmed cases of Osteoarthritis knee on X-ray
Exclusion criteria: Patients having other forms of inflammatory arthritis, patients with active peptic ulcer, significant renal, hepatic, hematological or cardiovascular disease and patients with hypersensitivity to NSAIDs, patients with h/o of skin disorders aggravated by drugs, patients of myasthenia gravis, pregnant women and nursing mothers
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Osteoarthritis knee
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Intervention(s)
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Intervention1: etodolac: etodolac
600mg OD orally for 8 weeks
Control Intervention1: combination of etodolac and eperisone hcl: etodolac 600mg OD and eperisone hcl 50mg tds orally for 8 weeks
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Primary Outcome(s)
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Pain intensity on Visual analog scaleTimepoint: At baseline, at 4 weeks and at 8 weeks
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Secondary Outcome(s)
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Joint tenderness,swelling,erythema,pain on movement,functional capacity and overall arthritic condition on Likert five point scaleTimepoint: baseline, 4 weeks and 8 weeks
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Source(s) of Monetary Support
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Government Medical College,Patiala
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Ethics review
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Status: Approved
Approval date: 11/12/2009
Contact:
Ethics committee, Government Medical College, Patiala
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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