Evaluation of the efficacy of teltonel drug in comparison with meloxicam in reducing pain and improving the function of patient with knee osteoartheritis
Design
The clinical trial has two treatment groups, with parallel, randomized groups
Settings and conduct
A randomized clinical trial of two treatment groups, with parallel groups, randomized on patients with knee oteoarthritis referred to Imam Reza Clinic, Chamran and Shahid Rajaei Hospital of Shiraz
Participants/Inclusion and exclusion criteria
Patients with knee osteoarthritis who consent to the intervention and have no history of drug allergy
Intervention groups
Group A Treatment with Meloxicam
Group B treatment with Teltonal drug
Main outcome variables
The scores from the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAK), Oxford Knee Score (OKS) and Visual analogue scale( VAS) questionnaires will be measured together
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191031045291N1
Registration date:2020-01-26, 1398/11/06
Registration timing:retrospective
Last update:2020-01-26, 1398/11/06
Update count:0
Registration date
2020-01-26, 1398/11/06
Registrant information
Name
Najmeh Rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 0861
Email address
n.rajabi.1372@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-07, 1398/09/16
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Tetonal drug in comparison with Meloxicam on pain relief and functional improvent of patient with knee osteoartheritis
Public title
Evaluation of the efficacy of Tetonal drug in comparison with Meloxicam on pain relief and functional improvent of patient with knee osteoartheritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patient aged 40-70
Clinical diagnosis of osteoarthritis
Patient had been symptomatic for one month
No periarticular disease
Exclusion criteria:
Collagen vascular disease
Radiculopathy
Brucella
Knee truma
Bmi >42
Bleeding tendency
History of drug reaction
Age
From 40 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the study, Blocked and cluster random method is used. Patients are also clustered by age and severity of symptoms. The list is compiled by a computer with the same block length and the clinic secretary divides the patients according to the list.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Faghihi hospital ,Ave.,zand Blvd
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2019-04-15, 1398/01/26
Ethics committee reference number
IR.SUMS.MED.REC.1398.271
Health conditions studied
1
Description of health condition studied
Knee osteoartheritis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
knee pain
Timepoint
Before the intervention, the second, fourth and eighth weeks after the intervention
Method of measurement
visual analogue scale (VAS) score, estern Ontario and McMaster Universities Osteoarthritis Index(WOMAC ) and Oxford Knee Score (OKS) questionnaires
2
Description
Knee function
Timepoint
Before the intervention, the second, fourth and eighth weeks after the intervention
Method of measurement
visual analogue scale (VAS) score, estern Ontario and McMaster Universities Osteoarthritis Index(WOMAC ) and Oxford Knee Score (OKS) questionnaires
3
Description
knee stiffness
Timepoint
Before the intervention, the second, fourth and eighth weeks after the intervention
Method of measurement
visual analogue scale (VAS) score, estern Ontario and McMaster Universities Osteoarthritis Index(WOMAC ) and Oxford Knee Score (OKS) questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Meloxicam from Iran Daroo company ,15 mg daily for 10 days
Category
Treatment - Drugs
2
Description
Intervention group 2: daily use of two tablets of Telnonal from Razak Company for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza clinic
Full name of responsible person
Hamidreza farpour
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
7134871473
Phone
+98 71 3212 7000
Email
farporh@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Younes Qasemi
Street address
Shiraz university of medical sciences، Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5884
Email
farporh@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz university of medical sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Rajabi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid Faghihi hospital, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3230 5884
Email
n.rajabi.1372@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamidreza Farpor
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Shiraz univercity of medical science,Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5884
Email
farporh@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Rajabi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shiraz univercity of meducal science,Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5884
Email
n.rajabi.1372@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available