Study the effect of topical application of 1% Stachys lavandulifolia extract gel and Declofenac gel in knee osteoarthritis on the pain and functional disability in patients with primary monoarticular knee osteoarthritis
The effect of topical gel application of 1% Stachys lavandulifolia and Diclofenac gel in Knee Osteoarthritis on the rate of pain and functional disability in patients with knee osteoarthritis
Design
This double blinded clinical trial was conducted by 150 patients with primary knee osteoarthritis who were randomly divided into 3 groups of 50 persons including control group receiving placebo, group receiving 1% Stachys lavandulifolia gel and group receiving 1% diclofenac gel.
Settings and conduct
This double blinded clinical trial study was conducted on the patients referred to hospitals in Shahrekord University of Medical Sciences. Participants information held secretly and other participants had not access to these information.
Participants/Inclusion and exclusion criteria
A definite diagnosis of primary osteoarthritis in a knee based on the doctor's diagnostic criteria is inclusion criteria. Primary osteoarthritis in both patient's knees is exclusion criteria.
Intervention groups
Intervention group: 1-Topical Gel Aqueous Hydrochloric Acid Extract with 200mg of Celecoxib Capsule 2- A topical gel with a percentage of diclofenac with 200 mg of celecoxib capsules. Control group: Topical Gel Placebo with 200 mg Celcioxide Capsules
Main outcome variables
The present study demonstrates that it can be used Stachys lavandulifolia gel can be used to reduce the pain in patients with primary knee osteoarthritis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190125042486N1
Registration date:2019-02-22, 1397/12/03
Registration timing:retrospective
Last update:2019-02-22, 1397/12/03
Update count:0
Registration date
2019-02-22, 1397/12/03
Registrant information
Name
Abolghasem sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 0061
Email address
gh_sh_fr51@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-01-10, 1397/10/20
Actual recruitment start date
2018-03-30, 1397/01/10
Actual recruitment end date
2019-01-10, 1397/10/20
Trial completion date
2019-01-10, 1397/10/20
Scientific title
Study the effect of topical application of 1% Stachys lavandulifolia extract gel and Declofenac gel in knee osteoarthritis on the pain and functional disability in patients with primary monoarticular knee osteoarthritis
Public title
Study the Effect of Topical Application of 1% Stachys lavandulifolia Extract Gel vs Diclofenac Gel in Knee Osteoarthritis on the pain and functional disability in patients with primary monoarticular knee osteoarthritis
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
A definite diagnosis of primary osteoarthritis in a knee based on the doctor's diagnostic criteria
the existence of pain at least for two weeks before beginning treatment
the age range between 45 years to 75 years old
Exclusion criteria:
Primary osteoarthritis in both patient's knees
Acute disease in liver or kidney
Ulcer pepticemia
Diabetes
Thyroid or parathyroid disease
Rheumatic arthritis
coagulation disease or consumption of anticoagulant drugs
History of ischemic stroke or hemorrhage
History of deep vein thrombosis
History of intra-articular injection during the last 6 weeks
Sensitivity to each form of anti-inflammatory drugs
Acute and pregnancy trauma
History of alcohol use and drug abuse
Skin diseases, infection or ulcers in the location of tropical use of medication
Oral use of other anti-inflammatory drugs and other effective compounds in the treatment of osteoarthritis 10 days before the beginning of the study
History of fracture or knee surgery
Age
From 45 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
150
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization (using random numbers table and software), samples devoted to each of the three groups: A, B and C, each group consisting of 50 sample.
Blinding (investigator's opinion)
Double blinded
Blinding description
All information of participants were recorded confidentially and secretly without name and with the code, and participants had not inform about the other participants other, clinical care provider also had not aware of the primary pain rate of participants
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
Deputy for Research and Technology, Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814646885
Approval date
2018-03-04, 1396/12/13
Ethics committee reference number
IR.SKUMS.REC.1397.66
Health conditions studied
1
Description of health condition studied
primary monoarticular knee osteoarthritis
ICD-10 code
M19.9
ICD-10 code description
Osteoarthritis, unspecified site
Primary outcomes
1
Description
pain and functional disability
Timepoint
Six weeks
Method of measurement
Data were collected by interview, Western Ontario and McMaster Universities Arthritis Index Standard Questionnaire (WOMAC), and Vase Analog scale(VAS).
Secondary outcomes
1
Description
Patient's function status
Timepoint
4 times and days 0, 14,28, 42
Method of measurement
intensity of pain by Visual Analog Scale (VAS) scale and the rate of pain on the patient,s function by Western Ontario and McMaster Universities Arthritis Index(WOMAC) questionnaire were measured
Intervention groups
1
Description
Intervention group: Topical Gel Aqueous Hydrochloric Acid Extract with 200 mg of Celecoxib Capsule
Category
Diagnosis
2
Description
Control group: Topical Gel Placebo with 200 mg Celcioxide Capsules
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational Clinic in Shahrekord University of Medical Sciences
Full name of responsible person
Morteza Dehghan
Street address
Parastar
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814646885
Phone
+98 38 3333 0061
Email
dehghan_m@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Kamal Solati
Street address
Deputy for Research and Technology, Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814646885
Phone
+98 38 3333 0061
Email
solat-k@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
No
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
Shahre-kord University of Medical Sciences
Full name of responsible person
Hsmidreza Asadian
Position
Rezident
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Deputy for Research and Technology, Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814646885
Phone
+98 38 3333 0061
Email
m_asadian67@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hamidreza Asadian
Position
Rezident
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Deputy for Research and Technology,Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814646885
Phone
+98 38 3333 0061
Email
m_asadian67@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Abolghasem Sharifi
Position
Master of science
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Deputy for Research and Technology
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814646885
Phone
+98 38 3333 0061
Email
gh_sh_fr51@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD