The aim of this study is to evaluate the influence of leaf powder savory pain and pro-inflammatory cytokines in patients with osteoarthritis of the knee. This study is a double-blind, placebo-controlled study in phase I clinical trials. The study population of patients with knee osteoarthritis are 40 to 70 years. The main inclusion criteria included individuals between the ages of 40 to 70 years; Knee osteoarthritis is diagnosed according to American College of Rheumatology.The main exclusion criteria included: patients less than 80% capsules are consumed; Patients who have inflammatory diseases, metabolic (diabetes), cancer, liver and kidney failure. Intervention in this study is daily consumption of 3 capsules dried savory leaves or 3 placebo capsules. Intervening period is between 23/09/2013 to 03/03/2014. In this study Pain, IL 1 beta and TNF-alpha will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112515542N1
Registration date:2013-12-17, 1392/09/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-17, 1392/09/26
Registrant information
Name
Maryam Asadi
Name of organization / entity
Ahvaz jundi shapoor university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8253
Email address
maryamasadi136@gmail.com
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-03-03, 1392/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Satureja Hortensis L .Leaf Powder on Pain and Pro
inflammatory Cytokines (TNF-α , IL-1β) in Patients with Knee Osteoarthritis
Public title
The Effect of Satureja Hortensis L. on Knee Osteoarthritis Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
The main inclusion criteria included individuals between the ages of 40 to 70 years; Knee osteoarthritis is diagnosed according to American College of Rheumatology.
The main exclusion criteria included: patients less than 80% capsules are consumed; Patients who have inflammatory diseases, metabolic (diabetes), cancer, liver and kidney failure.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Yazd University of Medical Sciences
Street address
Imam Reza Researh and Educational Complex , Daneshju Blvd.
City
Yazd
Postal code
8916189165
Approval date
2013-06-10, 1392/03/20
Ethics committee reference number
17/1/48454/پ
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
pain
Timepoint
Measured at baseline and 2 months after studies
Method of measurement
Visual Analogue linear scale
2
Description
TNF alpha
Timepoint
Measured at baseline and 2 months after studies
Method of measurement
ELISA
3
Description
IL1 beta
Timepoint
Measured at baseline and 2 months after studies
Method of measurement
ELISA
Secondary outcomes
1
Description
Heartburn
Timepoint
Every two weeks
Method of measurement
Question of patients
2
Description
Feeling the heat
Timepoint
Every two weeks
Method of measurement
Question of patients
Intervention groups
1
Description
Daily consumption of three capsules of 200 mg dried savory leaves half an hour after meals for 2 months.
Category
Treatment - Drugs
2
Description
Daily consumption of three capsules of 200 mg powder of starch half an hour after meals for 2 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam o Alanbia Subspecialty Clinic
Full name of responsible person
Ali Dehghan Assistant Professor of Rheumatology
Street address
Central Building of Yazd University of Medical Science, Shahid Bahonar Square
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hasan Mozaffari Khosravi
Street address
Central Building of Yazd University of Medical Science, Shahid Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Science
Full name of responsible person
Maryam Asadi
Position
Masters student in Nutrition and Health Sciences
Other areas of specialty/work
Street address
Imam Reza Research and Educational Complex , Daneshju Blvd
City
Yazd
Postal code
8916189165
Phone
+98 35 1724 9333
Fax
+98 35 1623 8555
Email
maryamasadi136@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hasan Mozaffari Khosravi
Position
Full Professor in Nutrition
Other areas of specialty/work
Street address
Central Building of Yazd University of Medical Sciences, Shahid Bahonar Square
City
Yazd
Postal code
8916978477
Phone
+98 35172401715
Fax
+98 72 54750
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Asadi
Position
Masters student in Nutrition and Health Sciences
Other areas of specialty/work
Street address
Imam Reza Research and Educational Complex, Daneshju Blvd
City
Yazd
Postal code
8916978477
Phone
+98 35 1724 9333
Fax
+98 35 1623 8555
Email
maryamasadi136@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)