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IRCT20190406043175N5 IRCT 2021-08-30 Mashhad University of Medical Sciences The effect of Portulaca oleracea capsule on knee osteoarthritis Clinical trial of Portulaca oleracea extract capsule on clinical indicators of osteoarthritis 2021-10-23 anticipated 80 Complete https://irct.ir/trial/57946 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we used Random Allocation software for randomization. The random sequence of samples was performed equally as Intervention and control groups using this software. For allocation concealment, sealed envelopes were used. In this method, each of the random sequences written on a card and is placed in the envelopes, respectively. Finally, the lid of the envelopes is glued and placed in a box, respectively. At the registration time, based on the order in which eligible participants enter the study, one of the envelopes of their choice will be opened and their assigned group will be revealed, Blinding description: The capsules were packaged in the same shape and coded by an expert one in the research center using Random Allocation Software. Patients, and evaluators assess the outcome, are not aware of the contents of the package and grouping, and samples were delivered to patients randomly using Allocation concealment. 2-3 Knee osteoarthritis. Intervention 1: Intervention group: Portulaca oleracea capsule (prepared in Pharmacological Research Center of Medicinal Plants) three times a day, and routine treatment with meloxicam tablets. Intervention 2: Control group: Placebo capsule (prepared in Pharmacological Research Center of Medicinal Plants) three times a day, and routine treatment with meloxicam tablets. 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 further information
public Fatemeh Forouzanfar
Mashhad University of Medical Sciences, Azadi square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2538 forouzanfarf@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Forouzanfar
Mashhad University of Medical Sciences, Azadi square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2538 forouzanfarf@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Initial symptomatic osteoarthritis in at least one knee by clinical or radiological criteria ACR (American College of Rheumatology) is approved Lack of proper adherence to routine drug treatment (meloxicam tablets) for at least two weeks before the study Score higher than 30 at baseline VAS scale 40 years 80 years Both The intra-articular injection of hyaluronic acid in the three months before the start of the study The 4-week treatment with oral corticosteroids before the start of the study Patients with a history of deep vein thrombosis Active liver or renal disease and malignancies Secondary osteoarthritis or suspected Patients treated with hormonal drugs Patients treated with anticoagulation drugs Patients with a history of ischemic or hemorrhagic stroke Treatment - Drugs Placebo Intervention group: Portulaca oleracea capsule (prepared in Pharmacological Research Center of Medicinal Plants) three times a day, and routine treatment with meloxicam tablets. Control group: Placebo capsule (prepared in Pharmacological Research Center of Medicinal Plants) three times a day, and routine treatment with meloxicam tablets. Pain. Timepoint: Early intervention, four weeks after the intervention, eight weeks after intervention. Method of measurement: Western Ontario and McMasters Universities Osteoarthritis Index (Womac) questionnaire and Visual Analog Scale (VAS) scale. Joint stiffness. Timepoint: Early intervention, four weeks after the intervention, eight weeks after intervention. Method of measurement: (Womac) questionnaire and (VAS) scale. Physical performance. Timepoint: Early intervention, four weeks after the intervention, eight weeks after intervention. Method of measurement: (Womac) questionnaire and (VAS) scale. Mashhad University of Medical Sciences Approved 2021-04-13 Ethics committee of Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Azadi Square, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)