Investigating the effect of methotrexate on reducing pain and improving quality of life in patients with knee osteoarthritis

Comparsion of the effectiveness of methotrexate with placebo in patients with knee osteoarthritis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251112067966N1

Enrollment

Registered

2026-01-27

Start date

2026-01-30

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Knee osteoarthritis. Osteoarthritis of knee

Interventions

Intervention 1: Intervention group: Methotrexate tablets 10 mg weekly (Thursday or Friday) for 6 months. Intervention 2: Control group: placebo weekly (Thursday or Friday) for 6 months.

Eligibility

Sex/Gender

All

Age

40 Years to 75 Years

Inclusion criteria

Inclusion criteria: Grade 1 and 2 of the knee osteoarthritis Age above 40 years and under 75 years The ability for pain diagnose and alertness

Exclusion criteria

Exclusion criteria: Contraindications for methotrexate administration Use of oral or topical steroids within 14 days prior to the study Intra-articular steroid injection within 90 days prior to the study Use of antioxidant supplements and anti-anxiety/depression medications for at least one month prior to the study Use of antibiotics containing Trimethoprim

Design outcomes

Primary

Measure	Time frame
Performance score in womac questionnaire. Timepoint: beginning of the study, 3 and 6 month later. Method of measurement: womac performance questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hasan Nasiri Khormuji

Boushehr University of Medical Sciences

m.nasirikhormooji@bpums.ac.ir+98 77 3345 5375

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026