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IRCT20210916052501N1 IRCT 2021-11-30 Mazandaran University of Medical Sciences Farfioun Effects on Osteoarthritis The effect of topical ointment prepared from Euphorbia macroclada Boiss on the clinical symptoms of primary knee osteoarthritis 2021-12-04 anticipated 25 Complete https://irct.ir/trial/58821 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random blocking; Assignment of patients to two treatment groups is done by random blocking method and in order to produce sequences free website www.randomization.com or randomizer.org is used. The sequence obtained by one of the colleagues is written in separate sheets and placed in sealed envelopes, and then it will be given to the main researcher for studing. In this way, the patient and the evaluating physician, and the researcher will not be awared of any type of treatment, Blinding description: participants; Research fellow; Clinical Attentive; The patient and the treating physician, who is responsible for evaluating the patient in terms of response to treatment, and the researcher will not know the type of treatment assigned to the patient (drug or placebo). Equalization of medicated ointment and placebo is required for blinding, the base of medicated ointment and placebo is the same but herbal extract is not used in placebo, so to match medicated ointment and placebo for ointment color, USP Pharmacopoeia colors, and for specific ointment smell, USP Authorized essential oils will be used. ointments are finally coded by the coding system. 3 Early chronic osteoarthritis. Intervention 1: Intervention group:time of intervention is 4 weaks.and pain control test is WOMAC index.and it is used in time 0 ,2 ,4 weak after initiating of terapy.medicine will be used TID ,and a fingertip unit.E.M extract +Eucerin+Antioxidant is used ,in topical ointment. Consume Selexib 100mg BD and omega 3 at a rate of 1 per day. Intervention 2: Control group: If both knees of the patient are involved, the criterion for evaluation is the knee that has more pain and limitation of movement. However, in order to simulate the color of the ointment, the authorized food colors of Pharmacopea USP will be used. The number of uses is three times a day and each time it is the amount of a finger The duration of use is up to 4 weeks continuously. Consume Selexib 100mg BD and omega 3 at a rate of 1 per day. Yes - There is a plan to make this available What will be shared: Data on primary outcomes and, if created, data on secondary outcomes When: 6 months after printing of results To whom: Researchers Producers Conditions: use of documents in the way of research is acceptable. commitment on not to use of documents in the way the same research and prodouction that we do. Where to obtain: Dr.Mohammad Yousofpoor(MAZUMS) m.yousofpoor@yahoo.com 00981133243117 Dr.Faranak Zaker_Danesh Pazhuhan Adonis Group(DPAG) fara_zk@yahoo.com 00982144434912 How to obtain: connection with DANESH PAZHOOHAN ADONIS.Dr Faranak Zaker Connection with Mazandaran University of Medical Science.Dr Mohhamad Yousofpoor approximately one month after publication Comments:
public Dr.Mohammad YoosefPoor
Faculty of Iranian Medical ,Bagban specific Clinic,khazar BLV
Sari Iran (Islamic Republic of) 4815733971 +98 11 3324 3117 m.yousofpoor@yahoo.com Mazandaran University of Medical Sciences scientific Dr.Faranak Zaker
18_yas complex_Bahar Alley_North Shahin_Jannat abad
Tehran Iran (Islamic Republic of) 1475895843 +98 21 4443 4912 fara_zk@yahoo.com Danesh Pazhuhan Adonis Group(DPAG) Iran (Islamic Republic of) Patients that their Early chronic osteoarthritis are confirmed by romatologist based on Kellgren_Lawrence criteria Early Chronic Osteoarthritis Grade1_2 40 years 75 years Both Patients with Psychological disorder or Cognitive disorders Patients with sever chronic disorders like insulin-dependent diabetes, Lupus, Kidney disease and patients with uncontrolled hypertension Joint pain because of joint replacement M17 Osteoarthritis of knee Treatment - Drugs Placebo Intervention group:time of intervention is 4 weaks.and pain control test is WOMAC index.and it is used in time 0 ,2 ,4 weak after initiating of terapy.medicine will be used TID ,and a fingertip unit.E.M extract +Eucerin+Antioxidant is used ,in topical ointment. Consume Selexib 100mg BD and omega 3 at a rate of 1 per day. Control group: If both knees of the patient are involved, the criterion for evaluation is the knee that has more pain and limitation of movement. However, in order to simulate the color of the ointment, the authorized food colors of Pharmacopea USP will be used. The number of uses is three times a day and each time it is the amount of a finger The duration of use is up to 4 weeks continuously. Consume Selexib 100mg BD and omega 3 at a rate of 1 per day. Dِecrease in Joint pain. Timepoint: 0_14-28. Method of measurement: WOMAC standard questionnaire. Rigidity of Joints. Timepoint: 0_14_28. Method of measurement: WOMAC. Phisical Disability. Timepoint: 0-14-28. Method of measurement: WOMAC. Mazandaran University of Medical Sciences Approved 2021-10-09 Ethics committee of Mazandaran University of Medical Sciences Beginning of Valie Asr HighWay, Forked Road Of Jooybar, Emam Square, Sari Sari Mazandaran Iran (Islamic Republic of)