The effect of Saffron supplement on active rheumatoid arthritis

The effect of Saffron consumption on some mediator genes of immunity and inflammation in adult with active rheumatoid arthritis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201707309472N15

Enrollment

Registered

2017-10-15

Start date

2017-10-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Active rheumathoid arthritis. Other specified rheumatoid arthritis

Interventions

Intervention 1: Control groups: Patients that refer to hospital shariati who wish to cooperate and have inclusion criteria will receive 100 mg maltodextrin (100 mg tablet) for 3 months. Intervention

Placebo

Control groups: Patients that refer to hospital shariati who wish to cooperate and have inclusion criteria will receive 100 mg maltodextrin (100 mg tablet) for 3 months

Intervention Group: Patients that refer to hospital shariatti who wish to cooperate and have inclusion criteria will receive 100mg of powdered saffron daily (by one 100 mg tablet) for 3 months.

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria : diagnosis of rheumatoid arthritis as American College of Rheumatology (ACR) criteria; patients with age over 18 years; having RA from 2 years ago; active rheumatoid arthritis; acceptance of patient; not having diabetes mellitus, hypertension, thyroid problem, renal failure and liver dysfunction; not smoking; not being pregnant or lactated; not receiving omega-3 or antioxidants supplements from 3 month ago; not getting contraceptive drugs; Exclusion criteria: reluctance for continuing the cooperation ; taking less than 80% of supplements given to patients at baseline (the compliance lower than %80); sudden onset of an acute disease; migration ; any change in drug and treatment protocol that can cause omission from study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
ROR-?t gene expression amount. Timepoint: before intervention AND 3 months after intervention. Method of measurement: real time PCR method in ??CT.;PPAR-? gene expression amount. Timepoint: before intervention AND 3 months after intervention. Method of measurement: real time PCR method in ??CT.;FoxP3 gene expression amount. Timepoint: before intervention AND 3 months after intervention. Method of measurement: real time PCR method in ??CT.;GATA3 gene expression amount. Timepoint: before intervention AND 3 months after intervention. Method of measurement: real time PCR method in ??CT.;NF-kB gene expression amount. Timepoint: before intervention AND 3 months after intervention. Method of measurement: real time PCR method in ??CT.;T-bet gene expression amount. Timepoint: before intervention AND 3 months after intervention. Method of measurement: real time PCR method in ??CT.;Interleukin-17. Timepoint: before intervention AND 3 months after intervention. Method of measurement: ELISA kit in pg/ml.;Interleukin-4. Timepoint: before intervention AND 3 months after intervention. Method of measurement: ELISA kit in pg/ml.	—

Measure

Time frame

ROR-?t gene expression amount. Timepoint: before intervention AND 3 months after intervention. Method of measurement: real time PCR method in ??CT.;PPAR-? gene expression amount. Timepoint: before intervention AND 3 months after intervention. Method of measurement: real time PCR method in ??CT.;FoxP3 gene expression amount. Timepoint: before intervention AND 3 months after intervention. Method of measurement: real time PCR method in ??CT.;GATA3 gene expression amount. Timepoint: before intervention AND 3 months after intervention. Method of measurement: real time PCR method in ??CT.;NF-kB gene expression amount. Timepoint: before intervention AND 3 months after intervention. Method of measurement: real time PCR method in ??CT.;T-bet gene expression amount. Timepoint: before intervention AND 3 months after intervention. Method of measurement: real time PCR method in ??CT.;Interleukin-17. Timepoint: before intervention AND 3 months after intervention. Method of measurement: ELISA kit in pg/ml.;Interleukin-4. Timepoint: before intervention AND 3 months after intervention. Method of measurement: ELISA kit in pg/ml.

—

Secondary

Measure	Time frame
BMI. Timepoint: before intervention AND 3 months after intervention. Method of measurement: formula.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Naheed Aryaeian

Iran University of Medical Sciences

n-aryaeian@sina.tums.ac.ir+98 21 8670 4750

Outcome results

None listed

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