Comparison of effectiveness of topical chamomile flower extract in sesame oil with Diclofenac gel and placebo on clinical symptoms in patients with mild to moderate knee osteoarthritis
This is a Double-Blinded randomized clinical study to compare the effects of chamomile flower extract in sesame oil with Diclofenac gel and placebo (liquid paraffin) on patients with clinical symptoms of knee osteoarthritis. 99 patients after taking signed informed consent, according to American College of Rheumatology classification criteria for osteoarthritis and Kellegren-Lawrence system of classification by the physiatrist, in the age range 65-38 years are accepted. They will allocate to three arms using block randomization. 30 acetaminophen 500 milligrams tablets 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 3 weeks will prescribe to intervention groups. Patients at the beginning and weekly from the beginning of the study will be evaluated by the WOMAC questionnaire until the third week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015013120885N1
Registration date:2015-03-10, 1393/12/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-10, 1393/12/19
Registrant information
Name
Ruhollah Shoara
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 0244
Email address
shoara@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-02-09, 1393/11/20
Expected recruitment end date
2015-03-19, 1393/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of topical chamomile flower extract in sesame oil with Diclofenac gel and placebo on clinical symptoms in patients with mild to moderate knee osteoarthritis
Public title
The evaluation of effectiveness of topical chamomile flower extract in sesame oil on clinical symptoms in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the age between 38-65 years; patient's written informed consent for inclusion; recognition of osteoarthritis by the physiatrist according to American college of rheumatology classification criteria; recognition of grade I to III by the physiatrist osteoarthritis according to Kellegren-Lawrence system of classification.
Exclusion Criteria: those who need more than 2 grams of acetaminophen per day; those who need to use other oral or intravenous analgesic; unwillingness to continue to participate in the study; sensitivity to study drugs; patients with other bone joint disorders like rheumatoid arthritis, gout, pseudo gout, infected arthritis, metabolic arthritis, traumatic arthritis, joint replacement, fibromyalgia, non-motor dysfunction related to hip or knee (radiculopathy and neuropathy); concomitant use of glucosamine and chondroitin sulfate; knee corticosteroid injection in the past 3 months; other articular corticosteroid injection in the past 1 month; taking muscle relaxant drugs; pregnancy; oral and local use of corticosteroid in 14 past days; muscle corticosteroid injection in the past 1 month; alcohol addicted; drug abuse; skin diseases in knee; patients with active renal, liver and peptic ulcer diseases; disability to cooperate in filling the forms (cognitive or language disorder).
Age
From 38 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
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
Shiraz University of Medical Sciences
Street address
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences, Zand Street.
City
Shiraz
Postal code
Approval date
2015-02-08, 1393/11/19
Ethics committee reference number
CT-9376-7366
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis
Primary outcomes
1
Description
Pain
Timepoint
At the beginning of intervention and after 1 week, 2 weeks and 3 weeks after the beginning of intervention
Method of measurement
WOMAC questionnaire
2
Description
Joint stiffness
Timepoint
At the beginning of intervention and after 1 week, 2 weeks and 3 weeks after the beginning of intervention
Method of measurement
WOMAC questionnaire
3
Description
Function
Timepoint
At the beginning of intervention and after 1 week, 2 weeks and 3 weeks after the beginning of intervention
Method of measurement
WOMAC questionnaire
4
Description
The need for acetaminophen 500 milligrams tablets
Timepoint
1 week, 2 weeks and 3 weeks after the beginning of intervention
Method of measurement
Asking from patients
Secondary outcomes
empty
Intervention groups
1
Description
Chamomile flower extract in sesame oil, three times a day, topically on the more painful knee
Category
Treatment - Drugs
2
Description
Diclofenac 1% topical gel, three times a day on the more painful knee
Category
Treatment - Drugs
3
Description
Liquid Paraffin, topically, three times a day on the more painful knee
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahhari Clinic
Full name of responsible person
Dr. Ruhollah Shoara
Street address
Iranian Traditional Medicine College, Medicine Faculty, Imam Hossein Square, Zand Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Basir Hashemi
Street address
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences, Zand Street.
City
Shiraz
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ruhollah Shoara
Position
The Assistant of Traditional Medicine
Other areas of specialty/work
Street address
Iranian Traditional Medicine College, Medicine Faculty, Imam Hossein Square, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3230 5886
Fax
Email
shoara@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ashraf
Position
Professor of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences - Department of Physical Medicine and Rehabilitation
City
Shiraz
Postal code
Phone
+98 71 3231 9040
Fax
Email
Ashrafa@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ruhollah Shoara
Position
The Assistant of Traditional Medicine
Other areas of specialty/work
Street address
Iranian Traditional Medicine College, Medicine Faculty, Imam Hossein Square, Zand Street
City
Shiraz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)