Formulation and clinical evaluation (Phase 2 clinical trial) of complementary therapy with b-Caryophyllene in osteoarthritis patients: determination of effectiveness and safety

Clinical evaluation of b-Caryophyllene in osteoarthritis patients

A double-blind, randomized, placebo-controlled, Phase 2 clinical trial study will be performed on 120 individuals divided into three groups.

The study will be performed on patients referred to the clinics of Mashhad University of Medical Sciences. After obtaining informed consent, patients are randomly divided into interventions 1 and 2 and placebo groups and take the drug daily for 8 weeks. Patients are evaluated weekly by a rheumatologist.

Inclusion criteria: Lack of proper response (VAS>30at 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 Exclusion criteria: 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 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

Intervention 1: Cap 30 mg of b-caryophyllene/day Intervention 2: Cap 150 mg of b-caryophyllene/day Control group (placebo): Cap containing corn oil base/day

Clinical indicators of knee osteoarthritis including pain, knee stiffness and physical function based on the WOMAC standardized questionnaire

Due to material import problems, the patient collection has not yet started. However, the researchers predict that patient recruitment will begin on 20/02/2026.

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.

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.