Protocol summary
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Study aim
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Topical effect of cannabis oil on some clinical signs of knee osteoarthritis in patients referred to Rafsanjan Rheumatology Clinic in 2022: a double-blind clinical trial
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Design
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A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 126 patients, stratified randomization was used for randomization.
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Settings and conduct
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clinical trial, will be performed on osteoarthritis patients referred to the Rheumatology Clinic in Rafsanjan in 2022, Patients will be evaluated at the beginning of the study and one to two months after the intervention using the Visual Analogue Scale (VAS) and the WOMAC index. In order to double-blind the study, Clinical symptoms are assessed by a Rheumatologist who is not aware of the type of medication used by each individual.
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Participants/Inclusion and exclusion criteria
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Iَnclusion: Age 45-70 years diagnosis of knee osteoarthritis according to American College of Rheumatology, approved by rheumatology specialist the average knee pain within 24 hours is based on the linear-visual pain scale (VAS) between 4 to 7.
Exclusion: Patients with inflammatory diseases, serious diseases, history of liver or kidney failure, oral corticosteroids, smoking and drug use, unwillingness to continue the study, non-compliance with the study protocol, Medical supplements use of analgesics, Skin or infectious disease at the site of pregnancy medication
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Intervention groups
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Participants will be divided into three groups: group 1 (42 people) using Cannabis oil, group 2 (42 people) placebo and group 3 (42 people) receiving diclofenac gel.
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Main outcome variables
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Pain and status of osteoarthritis in terms of morning stiffness, range of motion and function of patients
General information
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Reason for update
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Hemp seed oil is used in this research and method has changed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180811040759N2
Registration date:
2022-04-05, 1401/01/16
Registration timing:
prospective
Last update:
2023-07-01, 1402/04/10
Update count:
1
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Registration date
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2022-04-05, 1401/01/16
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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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2022-04-21, 1401/02/01
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Expected recruitment end date
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2022-06-20, 1401/03/30
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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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Effect of hemp seed oil on clinical symptoms in patients with Knee osteoarthritis referred to the Rheumatology Clinic of Rafsanjan in 2022: A randomized, double-blind, control trial
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Public title
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Effect of hemp seed oil on clinical symptoms in patients with Knee osteoarthritis referred to the Rheumatology Clinic of Rafsanjan in 2022: A randomized, double-blind, control trial
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 45-70 years
The diagnosis of osteoarthritis of the knee according to the criteria of the American College of Rheumatology, which is confirmed by a specialist in hematology
The presence of moderate knee pain within 24 hours based on linear-visual pain scale (VAS) between 4 7 cm
Completing the informed consent form
Exclusion criteria:
Patients with inflammatory diseases (such as lupus, rheumatoid arthritis, history of brucellosis, etc.)
Cancer or chronic diseases
Symptoms or history of liver or kidney failure
Oral corticosteroid consumption during the past 4 weeks
Corticosteroid injection in the last 6 months fever
Consumption of medical herbs continuously
Smoking and drug abuse
Allergy to hemp seed oil
Observe any side effects that the patient thinks are caused by the oil
use of food and drug supplements
Oral use of other analgesics regularly and advanced disease
Use of other topical medications at the site of drug administration
Skin or infectious disease or ulcers at the site of pregnancy medication
Reluctance to continue participating in the study
Failure to comply with the study protocol
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Age
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From 45 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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3
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Groups that have been masked
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization method. Unit: individual, simple random instrument: dice throwing one and two numbers for group 1 the numbers three and four for group 2 and the numbers five and six for group 3. Completion of groups with this sequence. Concealment is done using randomly coded boxes (allocation concealment).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The Physician and the patients will not be aware of the contents of the oil (double-blind). The duration of the massage is 3 to 5 minutes daily and the duration of taking the medicine is 2 months. The drugs are coded by someone other than the investigator and will be delivered to the Physician. Clinical examinations and confirmation of the disease are performed by a rheumatologist and subsequent evaluations are performed under the supervision of a rheumatologist and by an internal resident who will be unaware of the groups.
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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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2022-01-23, 1400/11/03
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Ethics committee reference number
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IR.RUMS.REC.1400.234
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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M17
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ICD-10 code description
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Osteoarthritis of knee
Primary outcomes
1
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Description
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Knee pain intensity
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Timepoint
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At the beginning and the end of the study (two months after the beginning of the study)
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Method of measurement
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Visual Analogue Scale (VAS) And WOMAC index
Intervention groups
1
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Description
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Intervention group: Group 1 (30 people) will use Cannabis oil. The treatment duration is 2 months, massage 3 to 5 minutes daily. During the study, patients are only allowed to use oral analgesics (7.5 mg of meloxicam) once daily in all groups if needed, and none of the common drugs will be used during this period.
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Category
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Treatment - Drugs
2
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Description
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Control group: Group 2 (Placebo) (30 people). the form and type of the drug is the same. The treatment duration is 2 months, massage 3 to 5 minutes daily. During the study, patients are only allowed to use oral analgesics (7.5 mg of meloxicam) once daily in all groups if needed, and none of the common drugs will be used during this period.
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Category
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Placebo
3
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Description
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Intervention group: Group 3 will receive Diclofenac gel. The treatment duration is 2 months, massage 3 to 5 minutes daily. During the study, patients are only allowed to use oral analgesics (7.5 mg of meloxicam) once daily in all groups if needed, and none of the common drugs will be used during this period.
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Category
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Treatment - Drugs
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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Rafsanjan 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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Not applicable
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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