The effect of Saffron supplement on active rheumatoid arthritis

The effect of Saffron supplement on clinical outcomes, inflammatory and oxidative markers in patients with active rheumatoid arthritis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201707139472N14

Enrollment

Registered

2017-09-15

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: Placebo group: For a period of 3 months (12 weeks), one tablet will contain 100 mg maltodextrin daily. Intervention 2: Saffron powder group: One day, one tablet will contain 100 mg of

Placebo

Placebo group: For a period of 3 months (12 weeks), one tablet will contain 100 mg maltodextrin daily.

Saffron powder group: One day, one tablet will contain 100 mg of saffron for 3 months (12 weeks).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: person with RA disease as American College of Rheumatology (ACR) criteria; aged 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 strickening to 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
Pain. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: visual analogue scales.;Morning stiffness. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: Examintion.;Number of inflammated joints. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: Examintion.;Number of swollen joints. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: Examintion.;DAS28. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: Examintion.;IFN-?. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: ELISA kit in pg / ml.;TNF-a. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: ELISA kit in pg / ml.;Hs-CRP. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: ELISA kit in ng / ml.;ESR. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: Westergern method.;MDA. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: Using the kits and colorimetric method in umol / L.;TAC. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: Using the kits and colorimetric method in umol / L.	—

Measure

Time frame

Pain. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: visual analogue scales.;Morning stiffness. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: Examintion.;Number of inflammated joints. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: Examintion.;Number of swollen joints. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: Examintion.;DAS28. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: Examintion.;IFN-?. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: ELISA kit in pg / ml.;TNF-a. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: ELISA kit in pg / ml.;Hs-CRP. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: ELISA kit in ng / ml.;ESR. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: Westergern method.;MDA. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: Using the kits and colorimetric method in umol / L.;TAC. Timepoint: Before the intervention and then three months after the intervention. Method of measurement: Using the kits and colorimetric method in umol / L.

—

Secondary

Measure	Time frame
Body mass index (BMI). Timepoint: Before the intervention and then three months after the intervention. Method of measurement: Calculation / in kg / m2.	—

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