Evaluation of therapeutic and immunologic effects of Crocina in knee osteoarthritis patients: A randomized double-blind placebo-controlled trial

Evaluation of therapeutic and immunologic effects of Crocina in knee osteoarthritis patients

A randomized, blinded controlled clinical trial with a parallel group design of 60 patients

This study will be carried out in Bojnurd's medical centers. After preparation of products, the main principal of the study will separate them into identical bottle for weekly consumption and mark them as A, B, C. The orthopedic physician, the patient and the student filling out data are blinded from arms of study. The patient will be asked to consume 1gram acetaminophen four times daily with one of the intervention medications daily for 16 weeks. At first visit, an informed consent form, demographic data, eligibility for enrolling the study, and thhe first blood sample will be collected.In weeks 1, 2, 3, 7, and 16, the patients will be visited and WOMAC, VAS and quality of life checklist will be filled out. The second blood sample will be obtained at week 16 (in total 16 visits).

Inclusion: 1) aged over 40 years 2) Primary osteoarthritis 3) Pain in more than half the days 4) Radiographic evidence 5) A score of 40 from the WOMAC scale as a base 6) No intra-articular injection of hyaluronic acid / glucocorticoid over the last six months 7) Lack of pregnancy Exclusion: 1) intolerance to the drug 2) Do not take medicine properly 3) Serious medical conditions 4) history of liver disease 5) Inability to walk without a cane 6) A history of autoimmune diseases such as rheumatoid arthritis 7) Secondary osteoarthritis, for example, following a trauma

Patients will be randomized into 3 groups of acetaminophen, with croscina or NSAID, or placebo, randomly divided into permutation blocks (each group 20).

Joint range of movement, pain

The eligible patients who meet the criteria will assigned into one of the intervention groups, by using a permuted block randomization method. Blocks of four will be used. Each prescribed medication will be given a six-digit number by the principal investigator. Patients, treatment team, and the investigator of clinical responses will not be aware of the types of interventions. At the end of the study, the principal investigator will decode the numbered consumed medications and assigne each to the appropriate group correctly.

Each prescribed medication will be given a six-digit number by the principal investigator. At the end of the study, the principal investigator will decode the numbered consumed medications and assigne each to the appropriate group correctly. The orthopedic physician, participated patients, and the medical student who is responsible for collecting data and filling out the questionnaire will be blinded to the intervention groups.