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IRCT20190406043175N8 IRCT 2022-10-02 Mashhad University of Medical Sciences The effect of ajor oil on knee osteoarthritis The effect of topical application of ajor oil on clinical indicators of knee osteoarthritis 2022-10-23 anticipated 80 Complete https://irct.ir/trial/65038 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method will be done using online random sequence generators. The blocks will be consisting of four sites filled by letter A or B. The combination of letters A and B will generate six blocks as follow: AABB, ABBA, BBAA, BAAB, ABAB, BABA. A number between 1 to 6 will be selected randomly and the corresponding combination will be used to assign the patients. For example, if the number 3 came up, the block number 3 with the combination of “BAAB”, the assignment of first 4 patients will be assigned. For assignment remaining 56 patients in to 2 groups we will need 14 more blocks which will be selected as previously explained, Blinding description: The blinding of randomized allocation will be done using closed envelopes method. the sequence of the patients will be placed inside a sealed envelope and upon arrival of the patient the envelope will be opened. 2-3 Knee osteoarthritis. Intervention 1: Intervention group: Ajor oil is made by the Pharmacological Research Center of Medicinal Plants. Its chemical composition consists of olive oil and brick’s solutes. The concentration of ajor oil is similar to olive oil which is mixed with heated brick pieces. Then using a special bar called reverse soxhlet with mild heat, the absorbed olive oil within the brick pieces is extracted. Next, the extracted oil will be standardized using oleic acid. Patients will receive topical treatment with ajor oil three times a day (5-10 drops) and routine treatment using meloxicam tablets. Intervention 2: Control group: Olive oil three times a day topically (five to ten drops), 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 more information
public Hassan Rakhshandeh
Mashhad University of Medical Sciences, Azadi square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2259 rakhshandehh@mums.ac.ir Mashhad University of Medical Sciences scientific Hassan Rakhshandeh
Mashhad University of Medical Sciences, Azadi square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2259 rakhshandehh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Primary symptomatic osteoarthritis in at least one knee confirmed by clinical or radiological criteria (American College of Rheumatology (ACR) criteria). No adequate response to medical treatment (Meloxicam) after at least two weeks of administration before the start of the study. A baseline visual analog scale (VAS) score higher than 30 at the beginning of the study. Patients aged 40 to 80 years 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 M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group: Ajor oil is made by the Pharmacological Research Center of Medicinal Plants. Its chemical composition consists of olive oil and brick’s solutes. The concentration of ajor oil is similar to olive oil which is mixed with heated brick pieces. Then using a special bar called reverse soxhlet with mild heat, the absorbed olive oil within the brick pieces is extracted. Next, the extracted oil will be standardized using oleic acid. Patients will receive topical treatment with ajor oil three times a day (5-10 drops) and routine treatment using meloxicam tablets. Control group: Olive oil three times a day topically (five to ten drops), 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). Joint stiffness. Timepoint: Early intervention, four weeks after the intervention, eight weeks after intervention. Method of measurement: Western Ontario and McMaster Universities Arthritis Index (WOMAC)questionnaire and Visual Analog Scale (VAS). Physical performance. Timepoint: Early intervention, four weeks after the intervention, eight weeks after intervention. Method of measurement: Western Ontario and McMaster Universities Arthritis Index (WOMAC)questionnaire and Visual Analog Scale (VAS). Mashhad University of Medical Sciences Approved 2022-02-26 Ethics committee of Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Azadi Square, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)