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IRCT20180126038510N1 IRCT 2018-08-25 Tabriz University of Medical Sciences Assessment of Palm date (Phoenix dactylifera L.) on clinical manifestation of knee Osteoarthritis Assessment of topical Palm date (Phoenix dactylifera L.) product on clinical manifestation of knee Osteoarthritis versus Diclofenac gel: A randomized clinical trial 2018-09-23 anticipated 94 Complete https://irct.ir/trial/29648 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block design randomization as individual by Random number table. 3 Osteoarthritis of Knee. Intervention 1: Intervention group: This group will expose Topical Palm date Preparation to their involved knees three times a day at a rate of one index of the index finger for 4 weeks.Preparation will prepare at the pharmacy lab at the Faculty of Traditional Medicine of Tehran University of Medical Sciences. Intervention 2: Control group: This group will expose Diclofenac jel to their involved knees three times a day at a rate of one index of the index finger for 4 weeks. 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 No more information
public Alireza Bagherzadehkarimi
No. 3, Alley 41, Goldasht St., Zafaranieh Ave.
Tabriz Iran (Islamic Republic of) 5166773183 +98 41 3668 3374 Bagerzadeha@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Alireza Bagherzadehkarimi
No. 3, Alley 41, Goldasht St., Zafaranieh Ave.
Tabriz Iran (Islamic Republic of) 5166773183 +98 41 3668 3374 Bagerzadeha@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Mild to moderate knee Ostoarthritis patients according to Kellegren-Lawrence (K-L) grading scale Pain at least in one knee in last 3 month ago Minimum annoying pain in last (at least ) 4 week before randomized selection according to VAS scale 40 years 70 years Both Allergy to topical preparation of Date palm and Diclofenac gel Skin lesion on the knee Secondary Osteoarthritis as Rhuomatoid arthritis,Gout,Infectious arthritis,Metabolic arthritis,Traumatic arthritis Operative knee joint replacement Topical or systemic steroid use since 14 day before study Intraarticular steroid injection since 90 day before study Pregnancy and lactation period Alcohol and opioid addiction Radiculopathy and Neuropathy History of any kind of knee operation and trauma Utilization of other analgesic drugs since study period Nonconformity of life style according to knee health M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group: This group will expose Topical Palm date Preparation to their involved knees three times a day at a rate of one index of the index finger for 4 weeks.Preparation will prepare at the pharmacy lab at the Faculty of Traditional Medicine of Tehran University of Medical Sciences. Control group: This group will expose Diclofenac jel to their involved knees three times a day at a rate of one index of the index finger for 4 weeks Score of knee pain intensity. Timepoint: Measuring the Score of knee pain intensity at the beginning of the study and 14 and 28 days after starting use of Palm date ointment. Method of measurement: Visual Analogue Scale And Western Ontario and McMaster Universities Osteoarthritis questionnaire. Score of knee stiffness intensity. Timepoint: Measuring Score of knee stiffness intensity at the beginning of the study and 14 and 28 days after starting use of Palm date ointment. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis questionnaire. Daily activity Score. Timepoint: Measuring of Daily activity Score at the beginning of the study and 14 and 28 days after starting use of Palm date ointment. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis questionnaire. Tabriz University of Medical Sciences Approved 2018-05-28 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences central building , Daneshgah Ave. , Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)