Effect of Saffron on Rheumatoid Arthritis treatment

Evaluation the effects of Saffron pill in comparison to placebo on rheumatoid arthritis disease activity level

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014071218453N1

Enrollment

Registered

2015-05-15

Start date

2015-05-22

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

Rheumatoid Arthritis. Rheumatoid arthritis, unspecified

Interventions

Intervention 1: Intervention group: Saffron pill containing 100 mg Saffron extract once a day for 4 months in addition to standard treatment including: - 5 mg Prednisolone daily - 7.5 mg oral Methotre

Treatment - Drugs

Intervention group: Saffron pill containing 100 mg Saffron extract once a day for 4 months in addition to standard treatment including: - 5 mg Prednisolone daily - 7.5 mg oral Methotrexate weekly -

Control group: Placebo pill containing "Sunset" paint once a day for 4 months in addition to standard treatment including: - 5 mg Prednisolone daily - 7.5 mg oral Methotrexate weekly - 5 mg Folic a

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: To have four criteria of ACR-1987 for Rheumatoid Arthritis; New patients who haven’t received any standard treatment up to the time of the study; Patients over 18 years old. Exclusion criteria: Pregnancy; Breast-feeding; Diagnosed sensitivity to saffron; Diagnosed hepatic and renal diseases; Other comorbid rheumatologic diseases; Malignancies and/or active infections; Diagnosed psychological diseases.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Disease activity level according to DAS28-ESR score. Timepoint: Beginning of study - 1 month after beginning of study - 2.5 months after beginning of study - 4 months after beginning of study. Method of measurement: Using determined formula for DAS28-ESR which is according to physical examinations, ESR level, and patient self-assessment.	—

Secondary

Measure	Time frame
HAQ-DI. Timepoint: Beginning of study - 1 month after beginning of study - 2.5 months after beginning of study - 4 months after beginning of study. Method of measurement: According to HAQ-DI questionnaire which is translated to Persian and its validation has been assessed.;EULAR response. Timepoint: 1 month after beginning of study - 2.5 months after beginning of study - 4 months after beginning of study. Method of measurement: According to EULAR criteria table on the basis of DAS28-ESR score.;Saffron pill adverse effects. Timepoint: 1 month after beginning of study - 2.5 months after beginning of study - 4 months after beginning of study. Method of measurement: According to check list containing known adverse effects of Saffron.	—

Measure

Time frame

HAQ-DI. Timepoint: Beginning of study - 1 month after beginning of study - 2.5 months after beginning of study - 4 months after beginning of study. Method of measurement: According to HAQ-DI questionnaire which is translated to Persian and its validation has been assessed.;EULAR response. Timepoint: 1 month after beginning of study - 2.5 months after beginning of study - 4 months after beginning of study. Method of measurement: According to EULAR criteria table on the basis of DAS28-ESR score.;Saffron pill adverse effects. Timepoint: 1 month after beginning of study - 2.5 months after beginning of study - 4 months after beginning of study. Method of measurement: According to check list containing known adverse effects of Saffron.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Heidari

Mashhad University of Medical Sciences

heidarih861@mums.ac.ir+98 51 3801 2753

Outcome results

None listed

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