Assessing the effect of purslane supplementation on clinical outcomes, inflammatory and oxidative stress markers in patients with rheumatoid arthritis: A parallel double-blinded randomized controlled clinical trial

Assessing the effect of purslane supplementation on clinical outcomes, inflammatory and oxidative stress markers in patients with rheumatoid arthritis

Clinical trial with control group, double-blind, randomized, phase 2 on 86 patients.

Rheumatoid arthritis patients referred to shariati Hospital in Tehran who are eligible for the study will have a blood test once at the beginning and once after the intervention and the factors will be measured.

Inclusion criteria: Diagnosis of Rheumatoid Arthritis Based on American College of Rheumatology (ACR) Criteria(If there are at least four criteria for six weeks of the criteria 1- Morning dryness for at least one hour in three joints or more 2- Arthritis of three joint areas or more 3- Arthritis of the hand joints 4- Symmetric arthritis 5- Rheumatoid nodules 6- Positive rheumatoid factor 7- Typical radiographic changes in the wrist and hand);The duration of the disease is at least one year;The patient expresses his / her consent to participate in the study Criteria for non-inclusion: Having any of the diseases of diabetes, hypertension, thyroid disorder and kidney failure and Liver dysfunction;Smoking;Taking supplements (omega 3, antioxidants, etc.) in the last three months;Taking contraceptives;Changes in the amount of medication taken in the past month;pregnancy and lactation

Two groups of 43 people with rheumatoid arthritis:43 people in the group receiving 500 mg purslane capsule and 43 people in the placebo receiving group (Maltodextrin capsule)

Hs-CRP; TNF-α; SOD; TAC; ESR;GPA; Number of painful joints; Number of inflamed joints; the pain;DAS28; joint stiffness;Telopeptide C;OC;PTH;ALP;CA

Hello and respect The data added to the study, with the aim of conducting a secondary clinical study entitled the effect of purslane extract on some bone markers in patients with rheumatoid arthritis: a parallel double-blind randomized clinical trial approved by the code of ethics IR.IUMS.REC.1403.312, from The main plan is done.

Method of assigning letters A and B on medicine and placebo: The pharmacist uses the coin toss and his personal contract to select the letter A or B for the drug and the other letter will be assigned to the pharmacist. And will stick these letters on the packages. From the type of drug label and placebo until the end of data analysis, the researcher, patient and analyst will not know and this position will remain confidential. Method of assigning letters A and B to patients randomly: Patients who refer to shariati Hospital for treatment of rheumatoid arthritis and are eligible for the study are based on a randomized list, which randomly divides the numbers 1 to 86 using SPSS software in letters A and B (each 43 items) will receive a medicine or placebo with the appropriate label.

purslane or placebo is coded by a third person who does not know the contents of the packages. Upon each person entering the study, based on the generated sequence, a packages containing the powder in which the code is recorded will be assigned to the person. None of the participants as well as the researcher and analyst will know the assigned groups. The packages are prepared by the company and placebo and purslane packages are similar in terms of internal and external appearance. After analyzing the data, the pharmacist will be asked for the title of the label (drug or placebo) to compile the report and write the findings section.

Only a section of the data, such as primary outcomes information or the like, will be shared

Access period start 5 months after results publishing.

The obtained data from current study will be available only for working researchers in academic and scientific institutions

5 months after the publicized papers from this study, the obtained data will be available to the researchers for further analysis.

Applicants can be communicated to correspond author be e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of Public Health, Iran University of Medical Sciences, Hemat Highway, Tehran Cell phone: +982186704743 Email: n-aryaeian@sina.tums.ac.ir

Publishing in scientific-research journals Applicants will be given access to the obtained data from current study by sending an email to correspond author.