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IRCT20200507047338N1 IRCT 2021-04-22 Rafsanjan University of Medical Sciences Evaluation of the effect of basil oil on knee osteoarthritis The effect of topical basil vera oil on clinical signs of knee joint osteoarthritis 2020-09-22 anticipated 42 Complete https://irct.ir/trial/48002 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple crash Random allocation with hexagonal blocks Patients are divided into three groups of control (piroxicam), intervention (basil) and placebo (paraffin) by using random allocation with hexagonal blocks. In this way, the control group is assigned the letter A, the intervention group is assigned the letter B, and the placebo group is assigned the letter C, and in six blocks with the letters A, B, and C, the states ABCABC, AABBCC, CBAACB, ABCCBA, CCABAB, AACCBB And .. it is written on separate sheets and thrown into the container and one of the sheets is randomly taken out of the container and the composition of the writing is written on it and returned to the container. Because the sample size in this study is 126 people, this operation will be repeated 21 times and each time the composition written on the sheet will be noted following the previously written composition. This procedure is performed by the student and the day before the random assignment, so patients and the rheumatologist do not know how people are in each group, Blinding description: Before starting the study, the drugs will be packaged by someone other than the researcher The drug is delivered by someone other than a rheumatologist The data analyst will also be unaware of the type of drug used by each person. 3 knee Osteoarthritis. Intervention 1: Control group: Piroxicam gel prepared from Rafsanjan pharmacy is used topically twice a day for three months for 3 to 5 minutes on the sore spot. Intervention 2: Intervention group1: To make the cream, using basil oil, By cold extraction method , which is a simple method and preserves the oil. 24 hours in one kilogram of sesame oil with indirect heat at 65 degrees Celsius, then apply the oil by filtering for three months and twice a day for 3 to 5 minutes topically. Intervention 3: Intervention group2:Cream is prepared from Farabi base and sesame oil, which is considered as a placebo for this trial, and it is used topically twice a day for three months for a period of 3 to 5 minutes. 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 Incomplete data
public Mohammad Hatamian
NO. emamali Dorm., ali ebne abitaleb hospital,. Emam ali street
Rafsanjan Iran (Islamic Republic of) 7717933777 +98 35 3272 4703 Mohammadhatamian974@gmail.com Rafsanjan University of Medical Sciences scientific Mohammad Hatamian
NO. emamali Dorm., ali ebne abitaleb hospital,. Emam ali street
Rafsanjan Iran (Islamic Republic of) 7717933777 +98 35 3272 4703 Mohammadhatamian974@gmail.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of knee osteoarthritis based on the criteria American College of Rheumatology, which is approved by a rheumatologist Average knee pain within 24 hours based on linear-Visually scale of pain between 4 and 7 cm Age limit between 45 and 70 years 45 years 70 years Both Patients with inflammatory diseases, cancer, or serious illnesses Symptoms or history of liver or kidney failure Oral corticosteroids for the past 4 weeks or corticosteroid injections for the past 6 months fever Consumption of medicinal plants continuously drug using Sensitivity to basil Lack of willingness to continue participating in the study Failure to comply with the study protocol observation the side effects of basil oil Taking supplements and medications, take regular daily painkillers, and be very advanced Using of other topical medications at the use drug site Oral use of other analgesics and other compounds effective in the treatment of osteoarthritis up to 10 days before the study Skin ill or infectious disease or wound at the site of drug use Pregnancy M17.10 Unilateral primary osteoarthritis, unspecified knee Treatment - Drugs Rehabilitation N/A Control group: Piroxicam gel prepared from Rafsanjan pharmacy is used topically twice a day for three months for 3 to 5 minutes on the sore spot. Intervention group1: To make the cream, using basil oil, By cold extraction method , which is a simple method and preserves the oil. 24 hours in one kilogram of sesame oil with indirect heat at 65 degrees Celsius, then apply the oil by filtering for three months and twice a day for 3 to 5 minutes topically. Intervention group2:Cream is prepared from Farabi base and sesame oil, which is considered as a placebo for this trial, and it is used topically twice a day for three months for a period of 3 to 5 minutes. Average knee pain. Timepoint: Before the study, one and three months later. Method of measurement: Visual Analogue Scale. Rafsanjan University of Medical Sciences Approved 2020-08-16 Ethics committee of rafsanjan University of Medical Sciences Central Organization,Imam Ali Boulevard,Rafsanjan rafsanjan Kerman Iran (Islamic Republic of)