The purpose of this study was evaluation of essential oil and ethanol extracted of satureja khozestanica on pain and joint inflammation in patients with osteoarthritis, compared with piroxicom. men and women who are over 30 years old are the population. Patients who use steroid injections or edible medications or local sedative ,pregnant and breastfeeding women will be excluded .the patient divided into 8 groups .each group contains 35. the control groups received piroxicom and placebo.the 6 intervention groups received the essential oil and the extract of Satureja khozestanica in 1,3,6 percent doses.
the pain in patient were recorded before, one and two weeks after intervention.
General information
Acronym
Saturicom
IRCT registration information
IRCT registration number:IRCT138902043760N2
Registration date:2014-10-20, 1393/07/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-20, 1393/07/28
Registrant information
Name
Marzieh Rashidipour
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 667 4776
Email address
m.rashidipour@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Razi Herbal Medicine Research Center, Lorestan University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of piroxicam and Satureja Khuzestanica essential oils and extracts in reducing pain in patients with osteoarthritis
Public title
Comparison of piroxicam and Satureja Khuzestanica essential oils and extracts in reducing pain in patients with osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Women and men over 30 years of age with osteoarthritis.
Exclusion criteria:Patients who use steroid injections؛ edible medications or local sedative؛ Pregnant Women؛ Women who are breastfeeding؛ Patients who are sensitive to the Satureja Khozestanica.
Age
From 30 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
245
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences, Khorramabad
City
Khorramabad
Postal code
6814989468
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
159
Health conditions studied
1
Description of health condition studied
Analgesic
ICD-10 code
Y45.9
ICD-10 code description
Analgesic, antipyretic and anti-inflammatory drug, unspecified
2
Description of health condition studied
Arthrosis
ICD-10 code
M19.9
ICD-10 code description
Arthrosis, unspecified
3
Description of health condition studied
osteoarthrosis
ICD-10 code
M15.4,M16,
ICD-10 code description
Erosive (osteo)arthrosis
Primary outcomes
1
Description
Pain
Timepoint
0,7,14
Method of measurement
VAS
Secondary outcomes
1
Description
skin irritation
Timepoint
Days 1,7,14
Method of measurement
VAS questionnaire.
Intervention groups
1
Description
Control group: receive piroxicom b.i.d Up to two weeks
Category
Treatment - Drugs
2
Description
Intervention group: receive the essential oil of Satureja khuzestanica 1%
b.i.d Up to two weeks
Category
Treatment - Drugs
3
Description
Intervention group: receive the essential oil of Satureja khuzestanica 3%
b.i.d Up to two weeks
Category
Treatment - Drugs
4
Description
Intervention group: receive the essential oil of Satureja khuzestanica 6%
b.i.d Up to two weeks
Category
Treatment - Drugs
5
Description
Intervention group: receive the extract of Satureja khuzestanica 1%
b.i.d Up to two weeks
Category
Treatment - Drugs
6
Description
Intervention group: receive the extract of Satureja khuzestanica 3%
b.i.d Up to two weeks
Category
Treatment - Drugs
7
Description
Intervention group: receive the extract of Satureja khuzestanica 6%
b.i.d Up to two weeks
Category
Treatment - Drugs
8
Description
Control group: receive Eucerin b.i.d Up to two weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Ashayer Hospital
Full name of responsible person
Marzieh Rashidipour
Street address
Enqelab st.
City
Khorramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Bahram Rasoulian
Street address
Razi Ave.
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan 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
Lorestan University of Medical Sciences
Full name of responsible person
Marzieh Rashidipour
Position
Ph.D student
Other areas of specialty/work
Street address
Razi Herbal Medicines Research Center
City
Khorramabad
Postal code
6814989468
Phone
+98 66 3320 4005
Fax
+98 66 3320 4005
Email
m_rashidi80@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Marzieh Rashidipour
Position
Ph.D student
Other areas of specialty/work
Street address
Razi Herbal Medicines Research Center
City
Khorramabad
Postal code
6814989468
Phone
+98 66 3320 4005
Fax
+98 66 3320 4005
Email
m_rashidi80@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Marzieh Rashidipour
Position
Ph.D student
Other areas of specialty/work
Street address
Razi Herbal Medicines Research Center
City
Khorramabad
Postal code
6814989468
Phone
+98 66 3320 4005
Fax
+98 66 3320 4005
Email
m_rashidi80@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)