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IRCT20180811040759N2 IRCT 2022-04-05 Rafsanjan University of Medical Sciences 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 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 2022-04-21 anticipated 90 Complete https://irct.ir/trial/62488 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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), Blinding description: 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. 3 osteoarthritis. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr. Mitra Abbasifard
Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital
Rafsanjan Iran (Islamic Republic of) 7717937555 +98 34 3428 0185 dr.mabbasifard@rums.ac.ir Rafsanjan University of Medical Sciences scientific Mitra Abbasifard
Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital
Rafsanjan Iran (Islamic Republic of) 7717937555 +98 34 3428 0185 dr.mabbasifard@rums.ac.ir Rafsanjan University of Medical Sciences Iran (Islamic Republic of) 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 45 years 70 years Both 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 M17 Osteoarthritis of knee Treatment - Drugs Placebo Treatment - Drugs 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. 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. 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. Knee pain intensity. Timepoint: At the beginning and the end of the study (two months after the beginning of the study). Method of measurement: Visual Analogue Scale (VAS) And WOMAC index. Rafsanjan University of Medical Sciences Approved 2022-01-23 Ethics committee of Rafsanjan University of Medical Sciences Ali-Ibn Abi-Talib Square Rafsanjan Kerman Iran (Islamic Republic of)