Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Pain severity, osteoarthritis index, mobility, serum inflammatory index, serum indices of oxidative stress
General information
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Reason for update
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Update the start time of the participants' recruitment
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Acronym
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IRCT registration information
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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
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Registration date
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2019-01-22, 1397/11/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-10-23, 1398/08/01
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Expected recruitment end date
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2020-10-23, 1399/08/02
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The effect of of black seed oil on knee osteoarthritis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-03-01, 1395/12/11
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Ethics committee reference number
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IR.TBZMED.REC.1395.1291
Health conditions studied
1
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Description of health condition studied
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Knee osteoarthritis
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ICD-10 code
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M19.8
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ICD-10 code description
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Other specified arthrosis
Primary outcomes
1
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Description
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Pain severity
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Timepoint
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Evaluating the pain scale at the beginning of the study (before intervention) and six weeks after the intervention began.
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Method of measurement
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Visual Analogue Scale
2
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Description
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Osteoarthritis index
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Timepoint
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Evaluating activity at the beginning of the study (before intervention) and six weeks after the intervention began.
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Method of measurement
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The Western Ontario and McMaster Universities Osteoarthritis Index questionnaire
3
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Description
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Mobility
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Timepoint
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Evaluating mobility at the beginning of the study and six weeks after the intervention began.
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Method of measurement
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Time up and go test
4
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Description
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Serum inflammatory high-sensitivity C-reactive protein index
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Timepoint
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Measuring serum level of C-reactive protein inflammatory factor at the beginning of the study and six weeks after the intervention began.
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Method of measurement
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Biochemical assay
5
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Description
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Serum stress oxidative index
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Timepoint
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Measuring serum level of total antioxidant capacity and 3,4-Methylenedioxyamphetamine at the beginning of the study and six weeks after the intervention began.
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Method of measurement
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Biochemical assay
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
3
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available