Evaluation Effect of Crocina on The Cellular Immune Responses in Osteoarthritis Patients

The effect of Crocina on the production of IL-4, IL-1 bet, IL-17, IL-10 and TGF-beta: The effect of crocina on gene expression of transcription factors T-bet, GATA-3. FOXP3, ROR-γt,; The effect of helper T cells type one and two, regulatory T cells and T helper type 17 cells; the effect of crocina on the reduction of pain and joint inflammation. Design: Randomized, Double-blind and Placebo controlled; Study population: Patients with Osteoarthritis; Volume: 40 persons; Method: Osteoarthritis patients will be divided into two groups according to age and sex; Crocina tablets will be prescribed to the first group a tablet 15 mg daily along with conventional Medicines; Placebo tablets will be prescribed to the second group along with the conventional medicines; Blood sampling of patients will be done before drug administering and four months after treatment. Major Inclusion Criteria: Osteoarthritis patients with age 40-75 years; The severity of joint damage between grade 2 and 3; Patients without history of injury; Patients with body mass index less than 30. Major Exclusion Criteria: Osteoarthritis patients with age 40-75 years; The severity of joint damage in grade one and four; Patients with history of injury and body mass index 30 or more. Intervention: Treatment with prescription of drug at dose of 15 mg daily crocin in the study group and placebo in the control group. Time: 4 months; Main outcome Measures: Osteoarthritis, Pain, Inflammation, Crocina, IL-4, IL-1 beta, IL-17, IL-10, TGF- beta, Cell surface protein CD127, The expression of T-bet, GATA-3, FOXP3, ROR-γt and the number of Th1, Th2, T-regulatory and Th17.