1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
06 Nov 2022
Formulation and clinical trial of two traditional formulations from Peganum harmala and Zataria multiflora for knee osteoarthritis
Protocol summary
Summary
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
2 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
3 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
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
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) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
empty
