Effect of Oral Methotrexate on Improvement of Nasal Polyps

Effect of Methotrexate on Symptoms and Nasal Polyp Size in Patients With Recurrent Chronic Rhinosinusitis With Nasal Polyps (CRSwNP): A Double-Blind Randomized Pilot Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120404009375N2

Enrollment

Registered

2026-05-10

Start date

2026-03-10

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Patients With Recurrent Chronic Rhinosinusitis With Nasal Polyps. Polyp of nasal cavity

Interventions

Intervention 1: Intervention group: Patients will receive oral methotrexate at a dose of 15 mg per week for 12 weeks, administered as divided doses over two consecutive days (Thursday and Friday). The

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age18 or greater than Diagnosis of recurrent Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) based on the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS 2020) criteria No use of biological medications during the past six months Written informed consent for participation in the study

Exclusion criteria

Exclusion criteria: Presence of active liver disease Severe leukopenia or thrombocytopenia, defined as White Blood Cell count (WBC) less than 3,000 per microliter or Platelet count (PLT) less than 100,000 per microliter Significant renal dysfunction defined as Creatinine Clearance (CrCl) less than 50 milliliters per minute Active infection with Mycobacterium tuberculosis (TB), Hepatitis B virus (HBV), or Hepatitis C virus (HCV) Alcohol abuse Known hypersensitivity to methotrexate

Design outcomes

Primary

Measure	Time frame
Nasal endoscopy score base on Lund–Kennedy score. Timepoint: At baseline (prior to the start of the intervention, week 0), and subsequently at weeks 4, 8, and 12 after the initiation of the intervention. Method of measurement: Endoscopic evaluation of the nasal cavity scored using the Lund–Kennedy index.	—

Secondary

Measure	Time frame
Sino Nasal Outcome 22 questionnaire score. Timepoint: At baseline (prior to the start of the intervention, week 0), and subsequently at weeks 4, 8, and 12 after the initiation of the intervention. Method of measurement: Sino-Nasal Outcome Test-22 Questionnaire.;Score of severity of symptoms (nasal congestion, nasal discharge, decreased sense of smell, and facial pain or pressure). Timepoint: At baseline (prior to the start of the intervention, week 0), and subsequently at weeks 4, 8, and 12 after the initiation of the intervention. Method of measurement: Patient-reported symptom severity will be measured using the Visual Analog Scale.	—

Measure

Time frame

Sino Nasal Outcome 22 questionnaire score. Timepoint: At baseline (prior to the start of the intervention, week 0), and subsequently at weeks 4, 8, and 12 after the initiation of the intervention. Method of measurement: Sino-Nasal Outcome Test-22 Questionnaire.;Score of severity of symptoms (nasal congestion, nasal discharge, decreased sense of smell, and facial pain or pressure). Timepoint: At baseline (prior to the start of the intervention, week 0), and subsequently at weeks 4, 8, and 12 after the initiation of the intervention. Method of measurement: Patient-reported symptom severity will be measured using the Visual Analog Scale.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSoheila Nikakhlagh

Ahvaz University of Medical Sciences

Nikakhlagh-s@ajums.ac.ir+98 61 3222 1838

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026