Evaluating the efficacy of capsules containing pomegranate seed extract in improving the symptoms of patients with rheumatoid arthritis

Evaluating the efficacy of capsules containing pomegranate seed extract in improving the symptoms of patients with rheumatoid arthritis

This is a clinical trial study with parallel groups, double-blinded randomized, will be conducted on 60 patients with rheumatoid arthritis. Assignment of patients to the study groups will be done by random numbers generation and using Excel.

This study will be performed on patients with rheumatoid arthritis referring to Golestan hospital in Ahvaz. At least 60 patients will be randomly assigned to one of two treatment groups. The patients and experimenters will not know about type of treatment and patient grouping and thus until the end of trial the study will be remained double-blinded.

Inclusion criteria: Diagnosis of rheumatoid arthritis according to American College of Rheumatology criteria, moderate to severe rheumatoid arthritis according to DAS28 (disease Activity Score 28 (DAS-28) criteria, consent to participate in the study; Exclusion criteria: Pregnancy, renal diseases, liver diseases, respiratory diseases, taking sex hormones, cancer

Intervention group: will be received 0.2 mg/kg/week methotrexate, 5 mg prednisolone 2 times a day and 200 mg pomegranate seed extract capsule 2 times a day for 2 months. Control group: will be received 0.2 mg/kg/week methotrexate, 5 mg prednisolone 2 times a day and placebo capsule 2 times a day for 2 months. (The appearance of the drug and placebo will be same).

Erythrocyte sedimentation rate (ESR), C reactive protein (CRP), Plasma level of Interleukin-17 (IL-17), Plasma level of Interleukin-6 (IL-6), count of tender joints (TJC) and swollen joints (SJC) before and after the treatment (end of 8th week)

Patients will be assigned into two groups by simple randomization method. Allocation of patients to the study groups will be done by random numbers generation and using computer by excel software. Random numbers will be generated in Excel with RAND function [(=RAND()*(60)] and with this function 60 random numbers will be created in the range of 1 to 60 in a column. Each patient will be assigned a two-digit code from 01 to 60. From the beginning of the first row, move down the column of random numbers and check the first two digits of the random numbers. The first 30 people seen in our code range will be placed in the first group (intervention) and the second 30 people will place in the second group (control). A person from hospital staff, who will not responsible for patient selection, enrollment, or treatment allocation, performs the randomization. The implementation of the random allocation sequence occurs without knowledge of which patient will receive which treatment.

Intervention (receiving capsules containing pomegranate seed extract or placebo) and patient evaluation will be carried out by a physician who is blinded to both treatment groups. Drug and placebo will be in similar shape, color, and taste and prepare in same capsules. Also patients and statistical analyzer will not know about patient grouping. For blinding patients, the drug and placebo are provided to patients in similar containers, which only the serial number are mentioned. At the end of the study, the serial is converted to groups A and B in Excel software. After doing statistical analysis it will be determines which group is drugs or placebo.