Osteoarthritis (OA)is the most common type of arthritis.Symptomatic treatment includes opioid and non opioid drugs, non-steroidal anti-inflammatory drugs, topical analgesics, analgesics, and intra-articular injection of steroid.Due to gastrointestinal ulcers or/and cardiac toxicity of these drugs,serious need for an effective treatment exists. The use of complementary and alternative therapies may help. In this regard, many topical and oral herbal medications are mentioned in Iranian traditional medicine treatises. This project is to investigate the analgesic effect of two processed rubbing oils from Syrian rue and Zaatar which are widely and cheaply available Iranian native plants.81 patients -40 to 75 years old- with diagnosis of knee OA based on ACR criteria and Complained of knee pain with intensity of at least 30 according to the VAS scale of 0-100 were selected. They divided in 3 groups (Zaatar , Syrian rue and placebo groups).Physician and the patient were not informed of the drug type. Patients took the drug three times a day, rubbed on the knee. All patients were seen at weeks 2 and 4 again and after examining the knee, the WOMAC and VAS questionnaires filled out.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205029622N1
Registration date:2012-08-30, 1391/06/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-30, 1391/06/09
Registrant information
Name
Zohreh Abolhassanzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1242 4255
Email address
abolhasanz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-01-16, 1390/10/26
Expected recruitment end date
2012-08-10, 1391/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation and clinical trial of two traditional formulations from Peganum harmala and Zataria multiflora for knee osteoarthritis
Public title
Effect of two traditional formulations from Syrian Rue and Zaatar for osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Diagnosis of knee OA based on ACR criteria; Complained of knee pain with intensity of at least 30 according to the VAS scale of 0-100; Not using steroidal, non steroidal and opioid analgesics since entering the study; Not using noninflammatory and immunosuppressive medications; Disease severity Mild to moderate.
Exclusion: Severe reduction of joint space in radiographic findings; Pregnancy; Simultaneous joint diseases including rheumatoid arthritis; Chronic inflammatory diseases; Osteoporosis and osteopenia.
Age
From 40 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
81
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
Zand Avenu, Shiraz University of Medical Science bulding
City
Shiraz
Postal code
Approval date
2012-01-15, 1390/10/25
Ethics committee reference number
CT-90-5921
Health conditions studied
1
Description of health condition studied
Ostearthritis
ICD-10 code
M19.0
ICD-10 code description
Primary arthrosis NOS
Primary outcomes
1
Description
Knee pain from osteoarthritis
Timepoint
before study, 4 weeks after
Method of measurement
Womac questionary and VAS
Secondary outcomes
empty
Intervention groups
1
Description
Group A: Zaatar oil, 3 times per day, 4 drops each time on knee.
Category
Treatment - Drugs
2
Description
Group B: Syrian Rue oil,3 times per day, 4 drops each time on knee for 4 weeks.
Category
Treatment - Drugs
3
Description
Group C:Placebo, 3 times per day, 4 drops each time on knee for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences, Motahhari Clinic
Full name of responsible person
Zohreh Abolhassanzadeh
Street address
Motahhari Clinic, Namazi Square, Zand Avenue
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of Traditional Pharmacy, School of Pharmacy,Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abdolali Mohagheghzadeh
Street address
Shiraz School of Pharmacy, Karafarin Avenue
City
Akbarabad, Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Traditional Pharmacy, School of Pharmacy,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
Department of Traditional Pharmacy, School of Pharmacy, Shiraz Univercity of Medical Sciences
Full name of responsible person
Zohreh Abolhassanzadeh
Position
Ph.D Student
Other areas of specialty/work
Street address
Shiraz School of Pharmacy, Karafarin Avenue
City
Akbarabad, Shiraz
Postal code
Phone
+98 71 1242 4255
Fax
Email
abolhasanz@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Traditional Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences
Full name of responsible person
Abdolali Mohagheghzadeh
Position
Pharmacognosy Professor, Ph.D
Other areas of specialty/work
Street address
Shiraz School of Pharmacy, Karafarin Avenue
City
Akbarabad, Shiraz
Postal code
Phone
+98 71 1242 4255
Fax
Email
mohaghegh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz School of Pharmacy
Full name of responsible person
Zohreh Abolhassanzadeh
Position
PhD student
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
abolhasanz@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)