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IRCT20220309054225N1 IRCT 2022-04-19 Yazd University of Medical Sciences The effect of curcumin (a substance extracted from turmeric) on the immune system and clinical signs in patients with rheumatoid arthritis 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 2022-05-05 anticipated 30 Complete https://irct.ir/trial/62382 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: in the study, the expression of a number of genes is examined by curcumin intervention, which genes are effective in the balance of immune cells, Randomization description: 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, Blinding description: 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). 2 Rheumatoid Arthritis. Intervention 1: Intervention group: Curcumin nanoformal drug with the specific name of Sina Curcumin produced by Elixir Nanocina Company, 40 mg capsule daily for a period of 3 months, in the group receiving curcumin along with routine drug. Intervention 2: Control group: placebo in a single dose daily for 3 months in the placebo group with routine medicine. Yes - There is a plan to make this available What will be shared: 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 . When: Access to information is approximately 4 to 6 months after the results are published To whom: Data from this study are available to patients, academic researchers, drug companies, and rheumatologists. Conditions: 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. Where to obtain: 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 How to obtain: 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 Comments:
public Marzieh Raisi
No. 2 , first alley , right , 14 Qalanbar St., Zahedan
Zahedan Iran (Islamic Republic of) 9816643181 +98 54 3343 8551 reisimarzieh2016@gmail.com Yazd University of Medical Sciences scientific Mahdi Atabaki
Department of Immunology , School of Medicine , Dr. Hesabi Sq., Zahedan Zahedan University of Medical Sciences ,
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3337 2151 atabaki80@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Patients are women The age range is between 18-65 years Measured by the European American College Rheumatology Criteria (EULAR-ACR) by a rheumatologist Their DAS (disease activity scort28) is between 8.2 and 5, which is assessed by a rheumatologist. 18 years 65 years Female Refusal to give informed consent Chronic Diseases affecting ESR, CRP levels such as diabetes and heart disease Pregnancy and lactation Nervous disorders Abnormal Creatinine (greater than 1/5) Abnormal liver enzymes (AST-ALT) (3 times normal) M06.9 Rheumatoid arthritis, unspecified Treatment - Drugs Placebo Intervention group: Curcumin nanoformal drug with the specific name of Sina Curcumin produced by Elixir Nanocina Company, 40 mg capsule daily for a period of 3 months, in the group receiving curcumin along with routine drug Control group: placebo in a single dose daily for 3 months in the placebo group with routine medicine Percentage of TH17 cell number. Timepoint: Measurement of TH17 cell count at the beginning of the study (before the intervention) and 3 months after the start of the use of curcumin nano-formulation or placebo. Method of measurement: Flow cytometry method. Abundance of Treg cell population (regulatory). Timepoint: Measurement of Treg cell count at the beginning of the study (before the intervention) and 3 months after the start of the use of curcumin nano-formulation or placebo. Method of measurement: Flow cytometry method. Gene expression Lnc-HOTAIR (Long non coding). Timepoint: Evaluation of Lnc-HOTAIR gene expression at the beginning of the study (before intervention) and 3 months after starting the use of curcumin nano-formulation or placebo. Method of measurement: First the primer design, then the cDNA synthesis is measured with special kits and finally with real time PCR. Gene expression Lnc-MEG3 (Long non coding). Timepoint: Evaluation of Lnc-MEG3 gene expression at the beginning of the study (before intervention) and 3 months after starting to use curcumin nano-formulation or placebo. Method of measurement: Measurement before intervention (curcumin or placebo) and 3 months after intervention. Gene expression mir-20b (micro RNA). Timepoint: Evaluation of mir-20 gene expression at the beginning of the study (before the intervention) and 3 months after the start of curcumin nano-formulation or placebo. Method of measurement: First the primer design, then the cDNA synthesis is measured with special kits and finally with real time PCR. Gene expression mir-223 (micro RNA). Timepoint: Evaluation of mir-223 gene expression at the beginning of the study (before intervention) and 3 months after starting to use curcumin nano-formulation or placebo. Method of measurement: First the primer design, then the cDNA synthesis is measured with special kits and finally with real time PCR. Gene expression FOXP3. Timepoint: Evaluation of FOXP3 gene expression at the beginning of the study (before intervention) and 3 months after the start of curcumin nano-formulation or placebo. Method of measurement: First the primer design, then the cDNA synthesis is measured with special kits and finally with real time PCR. Gene expression RORγt. Timepoint: Evaluation of RORγt gene expression at the beginning of the study (before intervention) and 3 months after starting to use curcumin nano-formulation or placebo. Method of measurement: First the primer design, then the cDNA synthesis is measured with special kits and finally with real time PCR. Measurement of C-Reactive Protein. Timepoint: Evaluation of CRP gene expression at the beginning of the study (before intervention) and 3 months after the start of curcumin nano-formulation or placebo. Method of measurement: It is measured with a mini neph nephelometer and its scale is milligrams per deciliter. ESR (erythrocyte sedimentation rate) measurement. Timepoint: Evaluation of ESR gene expression at the beginning of the study (before the intervention) and 3 months after the start of curcumin or placebo nano-formulation. Method of measurement: The ESR rate is performed by the Westergreen method on a scale of millimeters per hour. Anti-CCP measurement (antibody against cyclic citrulline peptide). Timepoint: Evaluation of Anti-CCP gene expression at the beginning of the study (before the intervention) and 3 months after the start of curcumin nano-formulation or placebo. Method of measurement: Dedicated kit with ELISA method. Disease activity in rheumatoid arthritis patients in the study groups. Timepoint: Before the start of the study and 3 months after taking the nanoformal drug curcumin. Method of measurement: Rheumatology criteria by European American College (EULAR-ACR), disease activity and number of sensitive and swollen joints and other related symptoms are evaluated by a rheumatologist. yazd Approved 2022-02-23 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Yazd Medical Sciences Campus , Anonymous Martyrs Boulevard , Prof. Hesabi Boulevard , Yazd Yazd Yazd Iran (Islamic Republic of)