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Evaluation of the effects of curcumin on the immune system in patients with rheumatoid arthritis

Nano-formulated Curcumin effects evaluation on TH1 and TH2 cell-related markers in patients with rheumatoid arthritis in comparison with the placebo group, a double-blind randomized clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220306054203N1
Enrollment
30
Registered
2022-05-18
Start date
2022-05-05
Completion date
Unknown
Last updated
2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis. Rheumatoid arthritis, unspecified

Interventions

Intervention 1: Intervention group: The nano-formulation drug curcumin (with the trade name of Sina Curcumin) produced by Elixir Nana Sina Company in the amount of 40 mg daily for a period of 3 months

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Female patients with rheumatoid arthritis Female patients with rheumatoid arthritis whose disease activity score is between 2.8 and 5 Female patients with rheumatoid arthritis between the age 18 to 65 years All female patients with rheumatoid arthritis who have been confirmed by rheumatology criteria of the EULAR -ACR College

Exclusion criteria

Exclusion criteria: The patient does not have informed consent Pregnant women or those who breastfeed People with chronic diseases such as diabetes, cardiovascular disease and other inflammatory and infectious diseases People with neuropsychiatric disorders People with abnormal liver enzymes (3 times more than normal) People with abnormal creatinine level (more than 1.5)

Design outcomes

Primary

MeasureTime frame
GATA Binding Protein 3 (GATA3). Timepoint: Measurement of GATA-3 gene expression at the beginning of the study (before the intervention) and 3 months after the start of curcumin nano-formulation drug or placebo. Method of measurement: Evaluation of GATA-3 expression, which is the transcription factor of helper T cell 1, and is measured against glyceraldehyde-3-phosphate dehydrogenase by real-time PCR.;MiR-155 gene expression. Timepoint: Measurement of miR-155 gene expression at the beginning of the study (before the intervention) and 3 months after the start of curcumin nano-formulation drug or placebo. Method of measurement: The expression level of miR-155, which is the gene affecting T-bet, is measured by U6 small nuclear 1 by real-time PCR.;MiR-146 gene expression. Timepoint: Measurement of miR-146 gene expression at the beginning of the study (before the intervention) and 3 months after the start of curcumin nano-formulation drug or placebo. Method of measurement: Expression of miR-146, which is a gene affecting GATA-3 compared to U6 small nuclear 1, is measured by real-time PCR.;Metastasis-associated lung adenocarcinoma transcript 1 gene expression (Lnc - MALAT1). Timepoint: Measurement of Lnc - MALAT1 gene expression at the beginning of the study (before the intervention) and 3 months after the start of curcumin nano-formulation drug or placebo. Method of measurement: Evaluation of Lnc-MALAT1 expression, which is the miR-155 inhibitor gene, is measured against glyceraldehyde-3-phosphate dehydrogenase by real-time PCR.;Plasmacytoma variant translocation 1 gene expression (Lnc-PVT1). Timepoint: Measurement of Lnc-PVT1 gene expression at the beginning of the study (before the intervention) and 3 months after the start of curcumin nano-formulation drug or placebo. Method of measurement: The expression of Lnc-PVT1, which is the miR-146 inhibitor gene, against glyceraldehyde-3-phosphate dehydrogenase is measured by real-time PCR.;Acute phase protein (C-Reactive Pro

Secondary

MeasureTime frame
Disease activity score of rheumatoid arthritis patients in the study groups. Timepoint: According to the classification criteria of the European-American College of Rheumatology, the activity of rheumatoid arthritis is measured at the beginning of the study (before the intervention) and 3 months after the start of the nano-drug curcumin. Method of measurement: According to the classification criteria of the European-American College of Rheumatology, the activity of rheumatoid arthritis is measured by a rheumatologist. For laboratory analysis, CRP is measured by a binding site kit with a mini neph nephrometer. The ESR is reported by the Westergreen method. Anti-CCP is measured by a dedicated kit.The number of sensitive and swollen joints is measured by a rheumatologis.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaeze Khamar

Yazd University of Medical Sciences

khamarfaeze@gmail.com+98 54 3321 0263

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026