Protocol summary
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Study aim
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The effect of Nigella sativa oil on the improvement of pain, joint stiffness and physical activity symptoms in patients with knee osteoarthritis
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Design
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This clinical trial study will be conducted in a double-blind, phase 2 -3 clinical trial on 80 knee osteoarthritis patients. Patients are randomly divided into two parallel groups. The patients fill the questionnaire sheet and receive the Nigella sative oil or placebo emulsion and Identification code (A or B) are recorded in the patient's medical records.
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Settings and conduct
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The knee osteoarthritis patients referring to Baghiatallah Hospital according to inclusion criteria randomly divided to Nigella sativa or placebo groups. Except main investigator, non of the medical stuff, patients, data collector and who evaluate the outcome, are unaware of the medication type.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Male or female 50 to 70 years old patients with knee osteoarthritis intensity of 1 or 2.
Exclusion criteria: Patients with secondary osteoarthritis, serious systemic disease and history of any other chronic inflammatory disease; history of arthroscopic, surgery, knee replacement; pregnant and breast-feeding women
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Intervention groups
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Nigella sativa oil: patients taking a tablespoon of Nigella sativa oil emulsion three times a day after food.
Placebo: patients taking a tablespoon of placebo emulsion three times a day after food.
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Main outcome variables
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1- Pain intensity using Visual Analog Scale questionnaire and
2- Arthritis Index, joint stiffness and physical activity using Western Ontario and McMaster Universities Arthritis Index questionnaire
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20080901001157N13
Registration date:
2018-03-27, 1397/01/07
Registration timing:
prospective
Last update:
2018-06-03, 1397/03/13
Update count:
1
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Registration date
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2018-03-27, 1397/01/07
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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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2018-04-20, 1397/01/31
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Expected recruitment end date
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2019-12-22, 1398/10/01
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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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Effects of oral Nigella sativa seed oil on osteoarthritis indexes in patients suffering from knee osteoarthritis
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Public title
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Effect of Nigella sativa 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:
Male or female patients with knee osteoarthritis 1 or 2 intensity according to physical examination and knee joint radiography
Age 50 to 70 years
Exacerbation of the disease at a rate of at least 2 units of sub-total pain score after discontinuation of analgesic drugs which was used at least 3 days a week during the last month
A minimum of 9 points out of 20 for pain, joint stiffness and physical activity of the patient according to the criteria of Western Ontario and McMaster Universities pain subscale index after discontinuing analgesic drug medications
Exclusion criteria:
Patients with secondary osteoarthritis due to a known disease
Patients with history of arthroscopy, surgery, knee replacement and injection to the knee joint during the last 6 months
Any serious systemic disease and other chronic inflammatory disease
Patients receiving steroid anti-inflammatory drugs, muscle relaxant, antidepressants, glucosamine, chondroitin, tramadol, topical analgesic agents Like the capsaicin
Alcohol consuming and drug abuse patients
Patients who refuse to stop analgesic drugs
No flares after discontinuation of analgesic drugs that using at least 3 days a week during the last months
Breast-feeding, pregnant women and who intend to have children
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Age
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From 50 years old to 70 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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For randomization, a random number table and block randomization method is used. In this method, eligible patients are divided into blocks of 4 patients. There is no significant difference between the patients in each block in terms of total pain score index . To half of the patients in a block, from the random numbers table, the numbers whose first digits are even and to other half patients, the numbers that first digit are odd are allocated. Then, half of the patients in the block which the first digit are even the Nigella sativa oil are assigned and the other half of the patients which the first digit are odd are assigned to the 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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Letters A or B are labeled on drug or placebo emulsion bottles. Other specifications on the labels are completely identical. Physician, nurse, patient, data collector and those who evaluate the outcome, are unaware of the nature and meaning of the letters A or B on the labels. Only the main investigator knows the nature of the labels. Patients are aware that they are either in the drug or in the placebo groups, but they are not aware of the type of group they are in.
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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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2018-01-16, 1396/10/26
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Ethics committee reference number
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IR.ACECR.Avicenanna.REC.1396.26
Health conditions studied
1
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Description of health condition studied
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Osteoarthritis
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ICD-10 code
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M19.9
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ICD-10 code description
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Osteoarthritis, unspecified site
Primary outcomes
1
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Description
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Severity of arthritis
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Timepoint
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Before and end of intervention after 1 month
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Method of measurement
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The Western Ontario and McMaster Universities Arthritis Index Questionnaire
2
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Description
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Extent of joint pain
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Timepoint
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Before and end of intervention after 1 month
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Method of measurement
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The Western Ontario and McMaster Universities Arthritis Index Questionnaire
3
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Description
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Extent of joint stiffness
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Timepoint
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Before and end of intervention after 1 month
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Method of measurement
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The Western Ontario and McMaster Universities Arthritis Index Questionnaire
4
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Description
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Extent of physical function
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Timepoint
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Before and end of intervention after 1 month
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Method of measurement
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The Western Ontario and McMaster Universities Arthritis Index Questionnaire
Secondary outcomes
1
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Description
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Dose of acetaminophen used
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Timepoint
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Before intervention and after 1 month at end of the intervention
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Method of measurement
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Daily recording of the acetaminophen dose used by the patient
2
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Description
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Pain intensity
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Timepoint
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Before and end of the study and after one month
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Method of measurement
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Visual Analog Scale questionnaire
Intervention groups
1
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Description
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Intervention group: Nigella sativa oil emulsion; Patients taking a tablespoon of nigella sativa oil emulsion three times a day after food (5 ml nigella sativa oil daily) for one month.
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Category
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Treatment - Drugs
2
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Description
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Placebo group: Placebo emulsion; Patients taking a tablespoon of placebo emulsion three times a day after food ( total 5 ml mineral oil taking per day) for one month.
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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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Yes
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Title of funding source
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Iranian academic center for education culture and research
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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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No - There is not 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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No - There is not a plan to make this available