The effect of oral administration and topical application of black seed oil (Nigella Sativa) on pain, function and serum indices of inflammation and oxidative stress in patients with knee osteoarthritis
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General information
2018-10-23, 1397/08/01
2019-10-23, 1398/08/01
20182019-10-23 00:00:00
2019-10-23, 1398/08/01
2020-10-23, 1399/08/02
20192020-10-23 00:00:00
empty
Update the start time of the participants' recruitment
Update the start time of the participants' recruitment
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به روز رسانی زمان شروع نمونه گیری بررسی شوندگان
به روز رسانی زمان شروع نمونه گیری بررسی شوندگان
Protocol summary
Study aim
Determination of oral administration and topical application of black seed oil on pain, function and serum indices of inflammation and oxidative stress in patient with knee osteoarthritis.
Design
This study is a randomized double blind phase 2 clinical trial in 45 patient with knee osteoarthritis.Participants will randomly be assigned in to 3 groups to take oral and topical nigela saliva oil and placebo.
Settings and conduct
Target population are all patient with moderate knee osteoarthritis that referred to the specialized clinics of Tabriz university of medical science.Sampling will be done by convenience non randomized method.To concealed the allocation , the same pack which numbered sequentially will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria include moderate knee osteoarthritis.
Exclusion criteria include rhomatologic disease;history of surgery on knee joint;history of lower limbs fracture which is affected knee joint surface;severe knee osteoarthritis;patient with neuropathy,skin rash and ulcer at knee area.
Intervention groups
Participants will be randomly divided into three groups to receive 1)oral black seed oil 2)topical black seed oil and 3)placebo.In group 1, 2.5 ml of oral black seed BID and topical placebo oil.In group 2, topical black seed oil and oral placebo oil, and in group 3, 2.5 ml of oral placebo oil and topical placebo oil will receive.
Main outcome variables
Pain severity, osteoarthritis index, mobility, serum inflammatory index, serum indices of oxidative stress
General information
Reason for update
Update the start time of the participants' recruitment
Acronym
IRCT registration information
IRCT registration number:IRCT20081004001292N5
Registration date:2019-01-22, 1397/11/02
Registration timing:prospective
Last update:2021-11-02, 1400/08/11
Update count:1
Registration date
2019-01-22, 1397/11/02
Registrant information
Name
Vahideh Toopchizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 984113335625
Email address
toopchi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-10-23, 1399/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral administration and topical application of black seed oil (Nigella Sativa) on pain, function and serum indices of inflammation and oxidative stress in patients with knee osteoarthritis
Public title
The effect of of black seed oil on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate knee osteoarthritis
Exclusion criteria:
Rheumatologic disorder such as rheumatoid arthritis
History of knee joint surgery
History of lower limb bone fracture which encounter knee joint surface
Severe knee osteoarthritis
Neuropathic or sensory disorders
Cutaneous disorder at knee area
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated randomly using random blocking method using blocks 8 and 12 and RASS software and 1: 1: 1 allocation ratio to three groups: (1) oral nigella sativa oil, (2) topical nigella sativa oil, 3) placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
To randomize a random number table and block randomization method will be use. In this method, eligible patients are divided into blocks of 15 patients.The members of the first group are given supplemental edible therapy with black seed oil and topical placebo oil. The second group uses the black seed oil as topical and edible placebo oil, and the third group or the control group receive placebo edible oil as well as topical placebo oil.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Ethics Committee of Tabriz University of Medical Sciences
Street address
Vice Chancellor for research, Tabriz University of Medical Sciences, Golgasht Str.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2017-03-01, 1395/12/11
Ethics committee reference number
IR.TBZMED.REC.1395.1291
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M19.8
ICD-10 code description
Other specified arthrosis
Primary outcomes
1
Description
Pain severity
Timepoint
Evaluating the pain scale at the beginning of the study (before intervention) and six weeks after the intervention began.
Method of measurement
Visual Analogue Scale
2
Description
Osteoarthritis index
Timepoint
Evaluating activity at the beginning of the study (before intervention) and six weeks after the intervention began.
Method of measurement
The Western Ontario and McMaster Universities Osteoarthritis Index questionnaire
3
Description
Mobility
Timepoint
Evaluating mobility at the beginning of the study and six weeks after the intervention began.
Method of measurement
Time up and go test
4
Description
Serum inflammatory high-sensitivity C-reactive protein index
Timepoint
Measuring serum level of C-reactive protein inflammatory factor at the beginning of the study and six weeks after the intervention began.
Method of measurement
Biochemical assay
5
Description
Serum stress oxidative index
Timepoint
Measuring serum level of total antioxidant capacity and 3,4-Methylenedioxyamphetamine at the beginning of the study and six weeks after the intervention began.
Method of measurement
Biochemical assay
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Edible Nigella Sativa oil manufactured by Barij essence's pharmaceutical company, 2.5 ml twice a day in addition topical placebo oil containing paraffin manufactured by Farabi's pharmaceutical company, which is in shape, smell and other appearance characteristics quite similar to the Nigella Sativa oil, topically twice a day for 45 days.
Category
Treatment - Drugs
2
Description
Second intervention group: Topical Nigella Sativa oil manufactured by Barij essence's pharmaceutical company, twice a day in addition edible placebo oil containing paraffin manufactured by Farabi's pharmaceutical company, which is in shape, taste, smell and other appearance characteristics quite similar to the Nigella Sativa oil, 2.5 ml twice a day for 45 days.
Category
Treatment - Drugs
3
Description
Control group: Edible placebo oil containing paraffin manufactured by Farabi's pharmaceutical company,which is in shape, taste, smell and other appearance characteristics quite similar to the Nigella Sativa oil, 2.5 ml twice a day in addition topical placebo oil containing paraffin manufactured by Farabi's pharmaceutical company, which is in shape, smell and other appearance characteristics quite similar to the Nigella Sativa oil, topically twice a day for 45 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Vahideh Toopchizade
Street address
Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
Toopchi.v@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Vice Chanceller for Research (VCR), Third Floor, Central Building no. 2, Tabriz University of Medical Sciences, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 1249
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
dolatkhahn@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
dolatkhahn@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
dolatkhahn@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available