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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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220309054225N1
Enrollment
30
Registered
2022-04-19
Start date
2022-05-05
Completion date
Unknown
Last updated
2022-05-02

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: 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 rec

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarzieh Raisi

Yazd University of Medical Sciences

reisimarzieh2016@gmail.com+98 54 3343 8551

Outcome results

None listed

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