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IRCT20210912052445N1 IRCT 2021-11-13 Rafsanjan University of Medical Sciences The effect of aqueous extract of pistachio pericarp on knee osteoarthritis Effect of topical aqueous extract of pistachio (Pistacia Vera L.) pericarp on knee osteoarthritis: A randomized double-blind controlled clinical trial 2022-04-21 anticipated 75 Complete https://irct.ir/trial/58649 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Since the three groups need to have the same sample size, the (Restricted randomization) method will be used to divide people into three groups. In this way, first a number is assigned to each patient (1 to 75), then the number of each patient is written on a piece of paper and the papers will be folded so that the number can not be seen on them, all the papers in one container pour and after mixing, divide them into three equal groups and pour in three separate containers (Each container will contain 25 pieces), and finally, using a coin toss, consider one container as group A, another B and the other as group C, Blinding description: In order to double--blind controlled clinical trial the study, before starting the study, the drugs will be placed in the same packages by someone other than the researcher and will be coded as A, B and C. The drug is prescribed by a rheumatologist in the form of drug A or B or C and the drug is delivered by another person. Evaluation of clinical symptoms is performed by an internal resident who does not know the type of drug used by each individual. 3 Osteoarthritis. Intervention 1: Intervention group: A: Piroxicam gel, Topical application twice a day, 8 weeks, Drug massage (3-5 minutes). Intervention 2: Intervention group: B: aqueous extract of pistachio pericarp (topical ointment), Topical application twice a day, 8 weeks, Drug massage (3-5 minutes). Intervention 3: Control group: C: Farabi base ointment for placebo, Topical application twice a day, 8 weeks, Drug massage (3-5 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 There is no more information
public Soudeh Khanamani Falahati-pour
Pistachio Safety Research Center, Food & Drug Deputy Building, Rafsanjan University of Medical Sciences, Next to the St.22, Taleghani Avenue, Rafsanjan, Iran
Rafsanjan Iran (Islamic Republic of) 7717735979 +98 34 3428 2703 s.falahatipour@rums.ac.ir Rafsanjan University of Medical Sciences scientific Soudeh Khanamani Falahati-pour
Pistachio Safety Research Center, Food & Drug Deputy Building, Rafsanjan University of Medical Sciences, Next to the St.22, Taleghani Avenue, Rafsanjan, Iran
Rafsanjan Iran (Islamic Republic of) 7717735979 +98 34 3428 2705 s.falahatipour@rums.ac.ir Rafsanjan University of Medical Sciences Iran (Islamic Republic of) age 45-70 years old diagnosis of knee osteoarthritis will be based on American College of Rheumatology (ACR) criteria, which will be approved by a specialist in rheumatology the presence of moderate knee pain within 24 hours will be based on Visual Pain Scale (VAS) to 4–7 cm 45 years 70 years Both Patients with inflammatory diseases (such as lupus, rheumatoid arthritis, a history of brucellosis, etc.) cancer or other serious diseases symptoms or history of liver or kidney failure Taking oral corticosteroids in the past 4 weeks corticosteroid injection during the last 6 months Fever continuous use of herbs smoking and drugs allergy to pistachios consuming of dietary and medicinal supplements consumption of pistachios during the two weeks before the start of the test Regular daily use of painkillers and very advanced disease use of other topical drugs at the site of drug use oral use of other analgesics and other effective compounds in the treatment of osteoarthritis up to 10 days before the study skin or infectious disease or wound at the site of drug use pregnancy M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: A: Piroxicam gel, Topical application twice a day, 8 weeks, Drug massage (3-5 minutes) Intervention group: B: aqueous extract of pistachio pericarp (topical ointment), Topical application twice a day, 8 weeks, Drug massage (3-5 minutes) Control group: C: Farabi base ointment for placebo, Topical application twice a day, 8 weeks, Drug massage (3-5 minutes) Intensity of knee pain on Visual Analogue Scale (VAS). Timepoint: Before intervention-8 weeks after intervention. Method of measurement: Visual Analogue Scale (VAS). Knee performance in Western Ontario and Mc Master (WOMAC). Timepoint: Before intervention-8 weeks after intervention. Method of measurement: Questionnaire Western Ontario and Mc Master (WOMAC). Rafsanjan University of Medical Sciences Approved 2021-06-26 Ethics committee of Rafsanjan University of Medical Sciences Pistachio Safety Research Center, Food & Drug Deputy Building, Rafsanjan University of Medical Sciences, Next to the St.22, Taleghani Avenue, Rafsanjan, Iran Rafsanjan Kerman Iran (Islamic Republic of)