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IRCT20210513051279N1 IRCT 2021-06-27 Babol University of Medical Sciences Evaluation the effect of ointment of pistacia Atlantica oil on primery knee osteoarthritis Evaluation the effect of ointment of pistacia Atlantica oil on primery knee osteoarthritis 2021-07-22 anticipated 92 Complete https://irct.ir/trial/56274 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done using random permutation blocks method. The size of the blocks is 4. Drugs in two categories (drug and diclofenac) are made by the study pharmacist and sent to the study statistics specialist. The statistician encodes them and places them in blocks of 4 (containing 2 numbers from each group). Unlock the codes will be done after the end of the study. In case of side effects, the drug code will be unlocked, Blinding description: ointment of pistacia Atlantica and diclofenac gel in cans with a single shape, with a similar label, will be prepared by a pharmacist in the laboratory of medicinal plants of the School of persian Medicine in Babol. It is then coded and blocked by a statistician and delivered to the researcher. The only person who knows the nature of the cans is the pharmacist who makes the medicine. 3 Primary osteoarthritis of the knee. Intervention 1: Intervention group: To prepare the medicine, pistacia Atlantica oil, which is traditionally oiled, is standardized and applied as ointment and packaged after standardization and quality control, under the supervision of a traditional medicine pharmacist in the pharmacy laboratory of the Faculty of Persian Medicine. Patients who were randomly assigned to the intervention group after enrollment were given an ointment containing pistacia Atlantica oil to be applied topically around the knee three times a day for 4 weeks. Patients will be visited three times at the start of treatment, 4 weeks after starting treatment, and 4 weeks after stopping treatment, and will be evaluated for medication as well as possible side effects such as skin irritation and itching and allergy symptoms. And KOOS and VAS questionnaires will be completed. Intervention 2: Control group: Patients in this group are given topical diclofenac gel in a package similar to the drug to be used topically around the knee up to three times a day for 4 weeks. Patients will be visited three times at the start of treatment, 4 weeks after starting treatment, and 4 weeks after stopping treatment, and will be evaluated for medication as well as possible side effects such as skin irritation and itching and allergy symptoms. And KOOS and VAS questionnaires will be completed. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared. When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: The conditions will be determined by the Faculty of Iranian Medicine of Babol University. Where to obtain: Fatemeh Azizi E-mail: F.azizi@mubabol.ac.ir How to obtain: After receiving the e-mail from the researcher, the data request is reviewed by the Faculty of Iranian Medicine and the Vice Chancellor for Research and Technology, and if the requested information is approved, it will be provided to the individual. Comments:
public Fatemeh Azizi
Faculty of persian Medicine, Babol University of Medical Sciences, Ganj Afrooz St., babol
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 4730 F.azizi@mubabol.ac.ir Babol University of Medical Sciences scientific Fatemeh Azizi
Faculty of persian Medicine, Babol University of Medical Sciences, Ganj Afrooz St., babol
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 4730 F.azizi@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) age between 50 to 80 years osteoarthritis grade 1 to 3 according to Kellgren-Lawrence Classification of Osteoarthritis in X Ray severity of pain 3 to 8 in VAS scale 50 years 80 years Both Attend another clinical study in the last 6 months Cognitive or mental disorder Taking oral and injectable corticosteroids in the last two months People who have a history of allergies to herbal medicines Patients with acute arthritis, osteoarthritis secondary to rheumatic diseases such as RA and gout, infectious arthritis, metabolic arthritis, traumatic arthritis, uncontrolled diabetes, known case of heart, liver, cancer Skin disease at the joint site Joint replacement through surgery Fiber myalgia, radiculopathy and neuropathy Patients taking glucosamine, chondroitin sulfate and muscle relaxants at the same time M17 Osteoarthritis of knee Treatment - Drugs Placebo Intervention group: To prepare the medicine, pistacia Atlantica oil, which is traditionally oiled, is standardized and applied as ointment and packaged after standardization and quality control, under the supervision of a traditional medicine pharmacist in the pharmacy laboratory of the Faculty of Persian Medicine. Patients who were randomly assigned to the intervention group after enrollment were given an ointment containing pistacia Atlantica oil to be applied topically around the knee three times a day for 4 weeks. Patients will be visited three times at the start of treatment, 4 weeks after starting treatment, and 4 weeks after stopping treatment, and will be evaluated for medication as well as possible side effects such as skin irritation and itching and allergy symptoms. And KOOS and VAS questionnaires will be completed. Control group: Patients in this group are given topical diclofenac gel in a package similar to the drug to be used topically around the knee up to three times a day for 4 weeks. Patients will be visited three times at the start of treatment, 4 weeks after starting treatment, and 4 weeks after stopping treatment, and will be evaluated for medication as well as possible side effects such as skin irritation and itching and allergy symptoms. And KOOS and VAS questionnaires will be completed. Joint pain score in VAS questionnaire. Timepoint: At the beginning of the study (before the intervention) and 4 weeks after the start of treatment and 4 weeks after the end of treatment. Method of measurement: VAS questionnaire score. Joint pain score in KOOS questionnaire. Timepoint: At the beginning of the study (before the intervention) and 4 weeks after the start of treatment and 4 weeks after the end of treatment. Method of measurement: KOOS questionnaire score. Joint symptoms score in the KOOS questionnaire. Timepoint: At the beginning of the study (before the intervention) and 4 weeks after the start of treatment and 4 weeks after the end of treatment. Method of measurement: Score in the KOOS questionnaire. Activity of daily live score in the KOOS questionnaire. Timepoint: At the beginning of the study (before the intervention) and 4 weeks after the start of treatment and 4 weeks after the end of treatment. Method of measurement: Score in the KOOS questionnaire. Sport. Timepoint: At the beginning of the study (before the intervention) and 4 weeks after the start of treatment and 4 weeks after the end of treatment. Method of measurement: Score in the KOOS questionnaire. Quality of life. Timepoint: At the beginning of the study (before the intervention) and 4 weeks after the start of treatment and 4 weeks after the end of treatment. Method of measurement: Score in the KOOS questionnaire. Babol University of Medical Sciences Approved 2021-04-30 Ethics Committee of Babol University of Medical Sciences University Research Ethics Committee, Babol University of Medical Sciences, Ganj Afrooz Square, babol Babol Mazandaran Iran (Islamic Republic of)