The aim of this study is to investigate the effects of Thymus daenensis gel 5% and diclofenac gel1% in pain of patients with knee osteoarthritis. This study is a double blind clinical trial,placebo-controlled, single-center is 120 patients with osteoarthritis referring to the Orthopedic Clinic in Shahrekord with Inclusion criteria: 45_75 years old; a definitive diagnosis of osteoarthritis disease with specialist Exclusion criteria: severe diseases such as metabolic disorders and digestive at the same time; severe infection, sensitivity to thyme extract daenensis, pregnancy, lactation, impaired liver function tests; history of fracture or knee surgery; rheumatoid arthritis are randomly select ,divide into three groups of 40 people. The first group receive placebo gel three times a day, the second group of thyme 5% topical gel three times daily and in the third group diclofenac topical gel 1% three times a day. All three groups use celecoxib 200 mg for oral. WOMAC and VAS questionnaires are checked at baseline and six weeks after treatment. Improving Physical symptoms and pain relief are considered as treatment response.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112231025N1
Registration date:2017-01-20, 1395/11/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-20, 1395/11/01
Registrant information
Name
Elena Khalesi
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3628 3372
Email address
st-khalesi.e@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Topical Application of Thymus daenensis Celak Extract Gel vs Diclofenac Gel in Knee Osteoarthritis
Public title
Thyme gel in reducing knee pain due to Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 45_75 years old; a definitive diagnosis of osteoarthritis disease with specialist Exclusion criteria: severe diseases such as metabolic disorders and digestive at the same time; severe infection, sensitivity to thyme extract daenensis, pregnancy, lactation, impaired liver function tests; history of fracture or knee surgery; rheumatoid arthritis
Age
From 45 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Approval date
2016-05-29, 1395/03/09
Ethics committee reference number
IR.SKUMS.REC.1395.54
Health conditions studied
1
Description of health condition studied
Osteoartritis
ICD-10 code
M19.9
ICD-10 code description
Arthrosis, unspecified
Primary outcomes
1
Description
Improving physical Function
Timepoint
Baseline and Six Weeks later
Method of measurement
WOMAC questionnaire
Secondary outcomes
1
Description
Pain relief
Timepoint
Baseline and Six Weeks later
Method of measurement
VAS questionnaire
Intervention groups
1
Description
The first group received placebo gel topically 3 times a day with 200 mg celecoxib capsules for oral use
Category
Treatment - Drugs
2
Description
The Second group received Thymus daenensis extract gel 5% gel topically 3 times a day with 200 mg celecoxib capsules for oral use
Category
Treatment - Drugs
3
Description
The Third group received diclofenac gel 1% gel topically 3 times a day with 200 mg celecoxib capsules for oral use
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital in Shahrekord
Full name of responsible person
Morteza Dhghan
Street address
Shahrekord, Shahrekord University Of Medical Sciences
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahrekord University of Medical Science
Full name of responsible person
Dr. Kamal Solati
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shahrekord University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Scienties
Full name of responsible person
Morteza Dehghan
Position
Associate Professor, Orthopedic specialist
Other areas of specialty/work
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
dehghan@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Morteza Dehghan
Position
Associate Professor, Orthopedic specialist
Other areas of specialty/work
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
dehghan@skums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Moreza Dehghan
Position
Associate Professor, Orthopedic specialist
Other areas of specialty/work
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
dehghan@skums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)