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IRCT20180811040759N4 IRCT 2023-03-30 Rafsanjan University of Medical Sciences Effect of lavender oil on some clinical symptoms of patients with knee osteoarthritis referred to the rheumatology clinic : a double blind randomised control trial Effect of lavender oil on some clinical symptoms of patients with knee osteoarthritis referred to the rheumatology clinic : a double blind randomised control trial 2023-04-04 anticipated 105 Complete https://irct.ir/trial/69288 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into three groups of 35 people, A, B, and C, using a simple randomization method (random number table). In group A, prepared paraffin oil without effect (placebo group), in group B, topical lavender oil (intervention group) and in group C, piroxicam gel (control group), Blinding description: In order to make the study double-blind, before the start of the study, the drugs are coded by someone other than the evaluator (secretary). Drug grouping and prescription is done by the rheumatology subspecialist in the form of drug A or B or C and drug delivery is done by another person (secretary). In addition, the analyzer is unaware of the grouping method and the drug used (double blind). In the placebo group, Paraffin oil, which is a ready-made pharmaceutical base without any effect, is used along with a color similar to lavender for placebo. The color of drug and placebo and the vials containing them are completely similar. 3 Osteoarthritis. Intervention 1: Control group: Group A (35 people) of prepared paraffin oil and without effect (placebo group), the form and type of medicine are the same. The duration of the treatment is 3 months, massage for 3 to 5 minutes daily. During the study, patients in all groups were only allowed to use non-anti-inflammatory oral pain relievers (such as Meloxifar 7.5 mg tablets) once a day as needed. Intervention 2: Intervention group: group B (35 people) topical lavender oil will be used. The duration of the treatment is 3 months, massage for 3 to 5 minutes daily. During the study, patients are only allowed to use oral painkillers (meloxifar 7.5 mg tablets) once a day in all groups if needed. Intervention 3: Intervention group: Group C (35 people) uses piroxicam gel (control group). The duration of the treatment is one month and the medicine is used topically once a day. The duration and amount of daily drug use are the same in the groups. During the study, patients were only allowed to use oral painkillers (meloxifar 7.5 mg tablets) once a day throughout. 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 It is not yet known if there will be a plan to make this available
public Mitra Abbasifard
Emam Ali Ave, rafsanjan university of medical sciences
Rafsanjan Iran (Islamic Republic of) 7717937555 +98 34 3428 0040 dr.mabbasifard@rums.ac.ir Rafsanjan University of Medical Sciences scientific Mitra Abbasifard
Emam Ali Ave, rafsanjan university of medical sciences
Rafsanjan Iran (Islamic Republic of) 7717937555 +98 34 3428 0040 dr.mabbasifard@rums.ac.ir Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Age 45-70 years The diagnosis of osteoarthritis of the knee is based on the diagnostic criteria of the American College of Rheumatology and the confirmation of the rheumatologist's diagnosis by a rheumatologist Existence of moderate pain in the knee during 24 hours based on the linear-visual scale of pain between 4-7 cm 45 years 70 years Both Allergy to lavender Reluctance to continue participating in the study Non-compliance with the study protocol Observing any side effects caused by lavender in the patient's opinion M17 Osteoarthritis of knee Placebo Treatment - Drugs Treatment - Drugs Control group: Group A (35 people) of prepared paraffin oil and without effect (placebo group), the form and type of medicine are the same. The duration of the treatment is 3 months, massage for 3 to 5 minutes daily. During the study, patients in all groups were only allowed to use non-anti-inflammatory oral pain relievers (such as Meloxifar 7.5 mg tablets) once a day as needed. Intervention group: group B (35 people) topical lavender oil will be used. The duration of the treatment is 3 months, massage for 3 to 5 minutes daily. During the study, patients are only allowed to use oral painkillers (meloxifar 7.5 mg tablets) once a day in all groups if needed. Intervention group: Group C (35 people) uses piroxicam gel (control group). The duration of the treatment is one month and the medicine is used topically once a day. The duration and amount of daily drug use are the same in the groups. During the study, patients were only allowed to use oral painkillers (meloxifar 7.5 mg tablets) once a day throughout Knee pain intensity. Timepoint: At the beginning and the end of the study (three months after the beginning of the study). Method of measurement: Visual Analogue Scale (VAS) And WOMAC index. Rafsanjan University of Medical Sciences Approved 2023-02-20 Ethics Committee of Rafsanjan University of Medical Sciences Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital Rafsanjan Kerman Iran (Islamic Republic of)