This is a single-Blinded (at the level of researchers and bio-statisticians) randomized clinical study to compare the effects of basil oil with Diclofenac gel on patients with clinical symptoms of knee osteoarthritis. 90 patients after taking signed informed consent according to American college of rheumatology classification criteria are accepted.The main exclusion criteria included: sensitivity to basil oil or Diclofenac gel or celecoxib; unwillingness to continue to participate in the study; joint replacement; concomitant use of glucosamine and chondroitin sulfate; knee corticosteroid or hyaluronic acid injection in the past 3 months; other articular corticosteroid or hyaluronic acid injection in the past 1 month; pregnancy or Lactating women; using oral or topical corticosteroid 14 days ago befor study be started. the patient will allocate to two arms using block randomization. Celexib tab 100 milligrams also given to the patients to use for pain relief if needed. Drugs will be encoding and without the name, three times a day for 2 weeks will prescribe to intervention groups. Patients at the beginning and once every 2 week from the beginning of the study will be evaluated for General status of pain, physical function and stiffness of joint by the WOMAC questionnaire until the fourth week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081711341N7
Registration date:2017-09-12, 1396/06/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-12, 1396/06/21
Registrant information
Name
Mohammad Hashem Hashempur
Name of organization / entity
Fasa University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 8476
Email address
hashempurm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Fasa University Of Medical Sciences
Expected recruitment start date
2017-09-15, 1396/06/24
Expected recruitment end date
2017-10-31, 1396/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of topical basil oil with Diclofenac gel in patients with knee osteoarthritis
Public title
The evaluation of effectiveness of topical basil oil on clinical symptoms in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the age between 30-70 years old; patient's written informed consent for inclusion; diagnosis of osteoarthritis by the orthopedist according to American College of Rheumatology classification criteria; grade I to III osteoarthritis according to Kellegren-Lawrence system of classification; pain of at least one knee during 3 months ago; no congenital abnormality of lower extremity. Exclusion Criteria: hypersensitivity to basil oil or Diclofenac gel or celecoxib; unwillingness to continue to participate in the study; secondary osteoarthritis due to rheumatologic diseases like rheumatoid arthritis, gout, pseudo gout, infected arthritis, metabolic arthritis, traumatic arthritis; joint replacement; concomitant use of glucosamine and chondroitin sulfate; knee injection of corticosteroid or hyaluronic acid in the past 3 months; other articular corticosteroid or hyaluronic acid injection in the past 1 month; use of oral or topical analgesic drugs 3 days before enrollment; pregnancy or Lactating women; alcohol addiction; drug abuse; using oral or topical corticosteroid 14 days days before enrollment; skin lesions of knee; disability to cooperate in filling the forms (cognitive or language disorder); the patient who use drugs that interact with celexib (e.g. lithium, fluconazole, warfarin, diuretics, ACE inhibitors like captopril, ARBs like losartan); patient with IBD or PUD; obesity (BMI ≥ 35 kg/m^2); use of physical modalities 2 weeks before enrollment (such as physical treatment, Acupuncture and Transcutaneous Electrical Nerve Stimulator).
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Fasa University of Medical Sciences
Street address
Fasa University of Medical Sciences, Ebnesina square, Fasa
City
Fasa
Postal code
Approval date
2016-03-08, 1394/12/18
Ethics committee reference number
IR.FUMS.REC.1394.39
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis
Primary outcomes
1
Description
General status of pain, physical function and stiffness of patients
Timepoint
At the beginning of intervention and after 2 week, 4 weeks after the beginning of intervention
Method of measurement
WOMAC questionnaire
Secondary outcomes
1
Description
Knee flexion angle
Timepoint
At the beginning of intervention and 2 week, 4 weeks after the beginning of intervention
Method of measurement
by using of standard goniometer
2
Description
Speed of walking
Timepoint
At the beginning of intervention and 2 week, 4 weeks after the beginning of intervention
Method of measurement
with measuring time of 8 meters walking
3
Description
The need for celexib 100 milligrams tablets
Timepoint
At the beginning of intervention and 2 week, 4 weeks after the beginning of intervention
Method of measurement
Asking from patients
4
Description
Joint stiffness
Timepoint
At the beginning of intervention and 2 week, 4 weeks after the beginning of intervention
Method of measurement
WOMAC questionnaire
5
Description
phyisical activity
Timepoint
At the beginning of intervention and 2 week, 4 weeks after the beginning of intervention
Method of measurement
Asking from patients
6
Description
Knee pain
Timepoint
At the beginning of intervention and 2 week, 4 weeks after the beginning of intervention
Method of measurement
VAS ruler, WOMAC questionnaire
Intervention groups
1
Description
Diclofenac 1% topical gel, three times a day on the l knee
Category
Treatment - Drugs
2
Description
basil oil, three times a day, topically on knee
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamzeh Clinic
Full name of responsible person
Dr Askari
Street address
Fasa University of Medical Sciences, Ebne sina square, Fasa, Fars, Iran
City
Fasa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Fasa University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Farjam
Street address
Fasa University of Medical Sciences, Ebnesina square, Fasa
City
Fasa
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, Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Sayyed Ali Ravansalar
Position
Medical student
Other areas of specialty/work
Street address
Fasa University of Medical Sciences, Ebne sina square, fasa
City
Fasa
Postal code
7461686668
Phone
+98 71 5335 0994
Fax
Email
dr_ali_ravanasalar2012@yahoomail
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr.Hashempur
Position
Traditional Medicine specialist
Other areas of specialty/work
Street address
Fasa University of Medical Sciences, Ebnesina square, Fasa, Fars, Iran
City
Fasa
Postal code
7461686668
Phone
+98 71 5335 0994
Fax
Email
hashempur@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Sayyed Ali Ravansalar
Position
Medical student
Other areas of specialty/work
Street address
Fasa University of Medical Sciences, Golestan dormitory, Ebne sina square, Fasa, Fars, Iran
City
Fasa
Postal code
7461686668
Phone
00
Fax
Email
dr_ali_ravanasalar2012@yahoomail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)