Objectives:
The effect of crocina on the production of IL-4, IL-1β, IL-17, IL-10 and TGF-β;The effect of crocina on gene expression of transcription factors T-bet, GATA3, FOXP3, ROR-gt; The effect of crocina on number of Th1 and Th2, regulatory T cells and Th17 cells; The effect of crocina on the reduction of pain and joint inflammation.
Design: Randomized, Double-blind and Placebo controlled; Study population: OA Patients; Volume: 40 persons; Method: Patients divided into two groups; Crocina tablets prescribed to the first group a tablet 15 mg daily along with the conventional medicines; Placebo tablets prescribed to the second group along with the conventional medicines; Blood sampling done before prescribing drug and four months Later.
Major Inclusion Criteria: OA patients aged 40 to 75; The severity of joint damage between grade 2 and 3; Patients with no history of injury; Patients with the Body Mass Index (BMI) less than 30.
Major Exclusion Criteria: OA patients aged less than 40 and more than 75; The severity of joint damage in grade 1 and 4; Patients with history of injury and BMI 30 or more.
Intervention: Treatment with drug; Prescription of crocina at dose of 15 mg daily; Prescription of placebo at dose of 15 mg daily in the control group.
Time: 4 months.
Main Outcome Measures: Osteoarthritis, Pain, Inflammation, Crocin, IL-4, IL-1β, IL-17, IL-10, TGFβ, CD127, Gene expression of T-bet; Gene expression of GATA3; Gene expression of FOXP3; Gene expression of RORgt; The number of Th1, Th2, T-regulatory and Th17.