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IRCT20180103038199N9 IRCT 2021-12-05 Mashhad University of Medical Sciences Evaluation of b-Caryophyllene in osteoarthritis patients BCPOAMP Formulation and clinical evaluation (Phase 2 clinical trial) of complementary therapy with b-Caryophyllene in osteoarthritis patients: determination of effectiveness and safety 2026-02-20 anticipated 120 Recruiting https://irct.ir/trial/60368 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by block method, the size of blocks is equal to six with three members A and B and C in a ratio of 1:1:1. Based on the sample size, 20 blocks are numbered in a different order from 1 to 20 and a random sequence of 20 blocks is determined using the site "WWW.Randomization.com", then the sequence of treatment groups A and B and C are determined in envelopes with number 1 Up to 120, with the inclusion of each eligible person, the envelope corresponding to the person's number is opened and the treatment group is determined, Blinding description: Due to the use of a placebo similar to the intervention treatment, the physician who associated with the participants and participants will not be informed of the assigned treatment. Also, the analyst will be unaware of the treatment assigned to the three groups. Finally, after analyzing the data, the researcher who prepared the packages reveals codes A, B, and C. The placebo will be very similar in treatment in terms of shape, consistency, packaging, and smell. 2-3 Osteoarthritis of knee. Intervention 1: Intervention group: Patients with primary osteoarthritis receive a 30 mg soft capsule of b-caryophyllene made by Mashhad University of Medical Sciences. Patients take this soft capsule orally once a day for 8 weeks. Intervention 2: Intervention group: Patients with primary osteoarthritis receive a 150 mg soft capsule of b-caryophyllene made by Mashhad University of Medical Sciences. Patients take this soft capsule orally once a day for 8 weeks. Intervention 3: Control group: Primary osteoarthritis patients receive a placebo soft capsule made by Mashhad University of Medical Sciences. Patients take this soft capsule orally once a day for 8 weeks. The placebo capsule is as same as intervention groups in terms of shape, colour, smell and taste. In order not to see the colour of the drug and placebo, the colour of the capsule is considered opaque and dark. The drugs are placed in blisters of the same shape, size, and colour. 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 Vahid Reza Askari
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2264 askariv@mums.ac.ir Mashhad University of Medical Sciences scientific Vahid Reza Askari
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2264 askariv@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Lack of proper response (having a score higher than 30 on the VAS numerical-visual scale at the beginning of the study) to the analgesic drug meloxicam after at least two weeks of drug administration before the start of the study Age between 40-70 years old Patients with BMI lower than 37 40 years 70 years Both Patient's dissatisfaction with continued cooperation during the study Need to perform any new therapeutic interventions during the study period Active liver or kidney disease and malignancies Secondary or suspected osteoarthritis Patients treated with hormonal medicines Patients treated with anticoagulants Patients with a history of ischemic or hemorrhagic stroke Patients with a history of deep vein thrombosis Treatment with oral corticosteroids 4 weeks before the start of the study Intra-articular injection of hyaluronic acid three months before the start of the study Pregnancy Patients who have had intra-articular corticosteroid injections in the last 4 weeks M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Placebo Intervention group: Patients with primary osteoarthritis receive a 30 mg soft capsule of b-caryophyllene made by Mashhad University of Medical Sciences. Patients take this soft capsule orally once a day for 8 weeks. Intervention group: Patients with primary osteoarthritis receive a 150 mg soft capsule of b-caryophyllene made by Mashhad University of Medical Sciences. Patients take this soft capsule orally once a day for 8 weeks. Control group: Primary osteoarthritis patients receive a placebo soft capsule made by Mashhad University of Medical Sciences. Patients take this soft capsule orally once a day for 8 weeks. The placebo capsule is as same as intervention groups in terms of shape, colour, smell and taste. In order not to see the colour of the drug and placebo, the colour of the capsule is considered opaque and dark. The drugs are placed in blisters of the same shape, size, and colour. Clinical indicators of osteoarthritis. Timepoint: At the beginning of the study and every week until the eighth week. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) standardized questionnaire. Complete Blood Cell Count with Differential. Timepoint: At the beginning and the end of the study. Method of measurement: Using an auto-analyzer system. Interleukin-4 level. Timepoint: At the end of the study. Method of measurement: Using a laboratory kit. Interferon-gamma level. Timepoint: At the end of the study. Method of measurement: Using a laboratory kit. Interleukin-10 level. Timepoint: At the end of the study. Method of measurement: Using a laboratory kit. High-sensitivity C-reactive protein (hs-CRP) level. Timepoint: At the beginning and the end of the study. Method of measurement: Using a laboratory kit. Mashhad University of Medical Sciences Approved 2021-11-06 Ethics committee of Mashhad University of Medical Sciences Deputy of Research and Technology of the University, Qurashi Building, Next to Hoveyzeh Cinema, University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)