Comparison of the effect of pistacia atlantica oleoresin (saqez) and diclofenac gel on clinical symptoms in patients with knee osteoarthritis : A double-blind , controlled trial.
This is a double-blinded randomized clinical study to compare the effects of herbal pistacia atlantica oleoresin ( saqez ) cream with diclofenac gel on patients with clinical symptoms of knee osteoarthritis. 84 patients with ACR criteria ( grade 2 and 3 ) with radiographic evidence between the ages of ( 35-85 ) and final diagnosis by the rheumatologist will be entered.
They will be allocated in to two arms in random. The drugs will be encoded, same shape without the name, 2 grams, 3 times a day for 12 weeks prescribed to both groups. Those patients who are unwilling to continue to participate in the study or sensitivity to the offered study drugs will be excluded. Patients at the base line, week 2, week six and week twelve will be reviewed on physical function, stiffness, pain and total symptoms with womac questionaries.
General information
Acronym
OA osteoarthritis
IRCT registration information
IRCT registration number:IRCT201506073106N26
Registration date:2015-07-06, 1394/04/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-06, 1394/04/15
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigators financial sources and Islamic azad university
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-07-06, 1394/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of pistacia atlantica oleoresin (saqez) and diclofenac gel on clinical symptoms in patients with knee osteoarthritis : A double-blind , controlled trial.
Public title
Effect of saqez cream on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's written consent; radiographic changes; primary knee osteoarthritis grade 2 and 3; age between 35 – 85; patients who did not receive topical treatment or received previous topical treatment for at least two weeks before they start on this trial. All patients must be stable on their current oral therapy.
Exclusion criteria:
Patients who needs more than 2 grams of acetaminophen in order to control pain; Those who need to use other oral or intravenous analgesics; Unwilling to continue or to participate in the study any further; Sensitivity to study drugs; Patients with other bone joint disorders: ( Rhumatoid Arthrities, Gout, Pseudo Gout, Infected Arthrities, Metabolic Arthrities, Traumatic Arthrities ) ; Infections and malignancy disease; Joint replacement; Fibro myalgia; Knee corticosteroid injection in the past 3 months, Pregnancy, oral and local use of corticosteroids; Pationts with active Renal, Liver and Peptic Ulcer Disease; Alcohol addicted; Drug Abuse
Age
From 35 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
85
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of pharmaceutical science branch of Islamic Azad University
Street address
No.99, Yakhchal street, Dr. Shariati Avenue Tehran
City
Tahran
Postal code
Approval date
2012-06-20, 1391/03/31
Ethics committee reference number
3332
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M19.0
ICD-10 code description
Primary arthrosis of other joints
Primary outcomes
1
Description
Physical function
Timepoint
2 Weeks,6 weeks and 12 weeks after baseline
Method of measurement
Womac questionaries
2
Description
Stiffness
Timepoint
2 Weeks,6 weeks and 12 weeks after baseline
Method of measurement
Womac questionaries
3
Description
Pain
Timepoint
2 Weeks,6 weeks and 12 weeks after baseline
Method of measurement
Womac questionaries
Secondary outcomes
empty
Intervention groups
1
Description
Saqez cream prepared by researcher, Knee local use, Dosage 2 grams per use, 3 times a day for 3 months
Category
Treatment - Drugs
2
Description
Pluse control group: diclofenac gel 1 % ( Iran najo ) ,3 times daily, 2 grams, for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-Ali hospital
Full name of responsible person
Dr. Mehdi Rajabi
Street address
Bu-Ali hospital, Damavand avenue, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Pharmaceutical Sciences Branch
Full name of responsible person
Dr. Sepideh Arbabi Bidgoli
Street address
No.99, Yakhchal street, Dr. Shariati Avenue Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Pharmaceutical Sciences Branch
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
Islamic Azad University, Pharmaceutical Sciences Branch
Full name of responsible person
Dr. Mehdi Rajabi
Position
Assistant professor / Head of Clinical Pharmacy Department
Other areas of specialty/work
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
Phone
+98 21 2264 0056
Fax
Email
mehdirj@aol.co.uk
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Pharmaceutical Sciences Branch
Full name of responsible person
Dr. Mehdi Rajabi
Position
Assistant professor / Head of Clinical Pharmacy Department
Other areas of specialty/work
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
Phone
+98 21 2264 0056
Fax
Email
mehdirj@aol.co.uk
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Pharmaceutical Sciences Branch