Clinical trial evaluating the effects of curcumin nanoformula on TH17 and Treg cell-related markers in patients with rheumatoid arthritis and comparing it with placebo

1) Determining and comparing the frequency of TH17 and Treg cell populations in the study groups before and after the intervention 2) Determining and comparing the expression of RORγt, FOXP3, mir-20b, mir-223, Lnc-HOTAIR and Lnc-MEG3 genes in the studied groups before and after the intervention 3) Determining and comparing CRP, ESR and Anti-CCP levels in the study groups before and after the intervention

Thirty female patients with RA who were divided into two intervention groups (curcumin nano-formulation and placebo), three-blind, randomized block classification randomized method, matched in terms of age and body mass index (Frequency matching) To be

Background: Rheumatoid arthritis Location: Ali Ibn Abitaleb Hospital in Zahedan Sample: 10cc of blood before and after the intervention Methods: 1- Molecular part: miRNA and total RNA isolated from blood, then cDNA synthesis and finally measuring the expression of the desired genes by real time PCR 2- Cellular section: Flow cytometric examination of TH17 and Treg cells 3- Laboratory analytes: CRP, ESR and Anti-CCP measurements

Female patients between 18-65 years old with rheumatoid arthritis with disease activity rate of 2.8 to 5 selected by rheumatologist Exclusion criteria: heart and infectious diseases, pregnancy and lactation, neurological disorders and patients with creatinine and abnormal liver enzymes

1- Curcumin nanoformal drug in a period of 3 months in the amount of 40 mg per day 2- Placebo which is given to the control group for 3 months

1- Changing the expression of genes considered in the study 2- Changing the percentage of TH17 and Treg cells 3. Changes in laboratory analytes considered by patients: CRP, ESR and Anti-CCP 4- Other than clinical signs and joint pain considered by the patient by a specialist

Randomization of patients into two groups is performed by permutation block stratified randomization method. First, the groups (eligible patients) are frequently matched in terms of age and body mass index. Then, based on the two blocks (consisting of two groups B, A) that are randomly selected from all possible modes of permutations, they are assigned to the desired group. These blocks were created using statistical software R version 4.0.2. Assuming that group A is taking placebo with routine and group B is taking curcumin with routine.

In this research, the triple blind study method is used. People who will not be aware of the intervention in this study include: 1- Participants (as we will explain to eligible patients that you have entered a study in which there are two groups of intervention, but they should not fully understand what group they are in, of course, the specialist assures them that this The intervention is made of natural materials and will not have significant side effects) 2- The person in charge of providing drugs and intervention (rheumatologist: in such a way that the interventions are completely identical in appearance so that the doctor does not understand the type of intervention until the end of the study, which examines the consequences and clinical signs with prior notice and Not a personal expectation) 3- Responsible for recording the laboratory results of the study (laboratory expert: in such a way that the blood sample is delivered to the expert with special coding so that he does not understand at all what kind of intervention the sample is using and according to personal request from the study result, the results Do not change) 4- Responsible for data analysis (Statistics Supervisor: As in the case above with the code, the results are announced until the data analysis is done without any personal intervention)

Information about the clinical part of the study is made available to patients after identifying individuals, and other information, including molecular, laboratory, and clinical studies, is provided to academic researchers in detail for further research in This field is helpful .

Access to information is approximately 4 to 6 months after the results are published

Data from this study are available to patients, academic researchers, drug companies, and rheumatologists.

It is explained to patients that after the information obtained from this study is in line with the improvement of clinical conditions, other patients should not be generally recommended to use it because the study is designed with certain criteria and under the supervision of pharmacologists, rheumatologists and immunologists. For academic researchers to obtain more information in this field, for example in their future research can be more maneuverable on the number of samples, the dose of drug use and even design more robust studies using molecular information and methods. Study information may be useful for the manufacturer to improve the quality of the drug.

For information about patients, refer to Dr. Mahnaz Sandoghi, a specialist in rheumatology Address: Ali Ibn Abi Taleb (AS) Hospital - Salamat Boulevard - Persian Gulf Highway Tel: 09151613472 Other information by request by email to Ms. Marzieh Raisi, Master of Immunology reisimarzieh2016@gmail.com

Study information 6 months after the publication of all domestic and foreign articles and receiving complete information from researchers who intend to research in this field, the information will be provided to them at intervals and in accordance with the law of copy paste