In this clinical trial, 120 patients with osteoarthritis of the knee according to VAS, will be selected and randomly divided into 3 groups of 35 persons. The first group will receive one mg topical diclofenac 1% 3 times daily, second group will receive 10% of Clove extract ointment 3 times daily , the third group will receive placebo topical 1 mg 3 times daily.
For all three groups questionnaire (WOMAC) in four sets, which includes baseline, one week, three weeks and four weeks after treatment will be completed. In the questionnaire, general pain, knee pain, morning stiffness, stiffness and physical activity throughout the day will be assessed
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501056480N8
Registration date:2015-01-27, 1393/11/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-27, 1393/11/07
Registrant information
Name
Mohammad Taghi Moradi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
mtmoradi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Science
Expected recruitment start date
2015-01-15, 1393/10/25
Expected recruitment end date
2015-04-11, 1394/01/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical application of Eugenia caryophylata extract compared with diclofenac and placebo on primary knee osteoarthritis
Public title
Effect of Eugenia caryophylata extract on primary knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : having 30 years old , maximum 60 years, knee osteoarthritis proven by clinical symptoms, examination and diagnosis criteria of this disease, which despite the usual care is not relieved for 3 months. Exclusion criteria: presence of severe concomitant diseases such as metabolic and gastrointestinal diseases, fluctuating doses of drugs during the study, severe infection, allergy to clove extract, pregnancy, lactation.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
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
Shahrekord University of Medical Sciense
Street address
Vice Chancellor for research of Shahrekord University of Medical Sciences, Kashani Boulevard
City
Shahrekord
Postal code
Approval date
2013-02-01, 1391/11/13
Ethics committee reference number
91-12-20
Health conditions studied
1
Description of health condition studied
primary knee osteoarthritis
ICD-10 code
M15.0
ICD-10 code description
Primary generalized (osteo)arthrosis
Primary outcomes
1
Description
general pain
Timepoint
baseline, one week, three weeks and four weeks after treatment
Method of measurement
questionnaire (WOMAC)
2
Description
stiffness
Timepoint
baseline, one week, three weeks and four weeks after treatment
Method of measurement
questionnaire (WOMAC)
3
Description
physical activity
Timepoint
baseline, one week, three weeks and four weeks after treatment
Method of measurement
questionnaire (WOMAC)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group received the amount of 1 mg of Clove extract ointment 10%3 times daily.
Category
Treatment - Drugs
2
Description
Intervention Group received 1 mg of topical diclofenac 1% 3 times daily .
Category
Treatment - Drugs
3
Description
Control group received1 mg of placepo ointment 3 times daily.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational Clinic of Shahrekord University of Medical Science
Full name of responsible person
Dr. Mortaza Dehghan
Street address
Educational Clinic of Shahrekord University of Medical Science, Shariati Blvd.
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery for Research and Technology,Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mahmoud Mobasheri
Street address
Vice Chancellor for research of Shahrekord University of Medical Sciences, Kashani Boulevard
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for Research and Technology,Shahrekord University of Medical Sciences
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 Sciences
Full name of responsible person
Dr Morteza Dehghan
Position
Assistant Profrssor
Other areas of specialty/work
Street address
Shahrekord University of Medical Science, Kashani Boulevard
City
Shahrekord
Postal code
Phone
+98 38 3334 2414
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Science
Full name of responsible person
Doctor Morteza Dehghan
Position
Orthopedic Specialist
Other areas of specialty/work
Street address
Orthopedic Department , Kashani Hospital,Parastar St
City
Shahrekord
Postal code
Phone
+98 38 3334 2414
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)