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IRCT20120404009375N2 IRCT 2026-05-10 Ahvaz University of Medical Sciences 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 2026-03-10 anticipated 40 Recruiting https://irct.ir/trial/89305 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly allocated into two study groups using the SealedEnvelope.com/randomisation website. Block randomization with variable block sizes (4 or 6) with a 1:1 allocation ratio will be used. The randomization process will be performed by an epidemiologist, Blinding description: This study will be conducted in a double‑blind manner (participants and outcome assessor/examining physician). The study drug and placebo will have identical packaging and labeling. Participant assignment will be concealed using alphanumeric codes (concealment). The randomized code list will be kept in two copies by the study epidemiologist and the principal investigator, and will only be broken in case of emergency. 3 Patients With Recurrent Chronic Rhinosinusitis With Nasal Polyps. 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 methotrexate used is Trexoma® 2.5 mg tablets (Nano Alvand Pharmaceutical Nanotechnology Company). In addition, folic acid 5 mg will be administered once weekly (Shafa Pharmaceutical and Hygienic Company).All patients will receive standard therapy, including intranasal fluticasone spray twice daily (Koushan Pharmed Company) and nasal and sinus irrigation with saline solution 1–2 times daily (SGALESH Nasal and Sinus Irrigation Solution).In case of severe exacerbation of symptoms, a short course (up to one week) of oral prednisolone (Aburaihan Pharmaceutical Company) may be prescribed. The dose and duration of prednisolone use will be recorded and considered in the data analysis. Intervention 2: Control group: patients will receive placebo tablets matching oral methotrexate at a dose equivalent to 15 mg per week, administered as divided doses on two consecutive days (Thursday and Friday) for a duration of 12 weeks. The placebo tablets will be prepared to resemble Trexoma 2.5 mg tablets manufactured by Nano Alvand Pharmaceutical Nanotechnology Company. Additionally, folic acid 5 mg will be prescribed once weekly. The folic acid used in this study is manufactured by Shafa Pharmaceutical and Hygienic Company. All patients will also receive standard therapy, including intranasal fluticasone spray twice daily manufactured by Koushan Pharmed Company, and nasal and sinus irrigation with saline solution one to two times daily using SGALESH Nasal and Sinus Irrigation Solution. In case of severe exacerbation of symptoms, oral prednisolone manufactured by Aburaihan Pharmaceutical Company may be prescribed for a short course of up to one week. The dose and duration of prednisolone use will be carefully recorded and considered in the data analysis. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is "No additional information is available"
public Soheila Nikakhlagh
Otorhinolaryngology Department, Imam Khomeini Hospital, 24‑Metri Street, Ahvaz, Khuzestan Province, Iran
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3222 1838 Nikakhlagh-s@ajums.ac.ir Ahvaz University of Medical Sciences scientific Soheila Nikakhlagh
Otorhinolaryngology Department, Imam Khomeini Hospital, 24‑Metri Street, Ahvaz, Khuzestan Province, Iran
َAhvaz Iran (Islamic Republic of) 61357-15794 +98 61 3222 1838 Nikakhlagh-s@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 60 years Both 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 J33.0 Polyp of nasal cavity Treatment - Drugs Treatment - Drugs 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 methotrexate used is Trexoma® 2.5 mg tablets (Nano Alvand Pharmaceutical Nanotechnology Company). In addition, folic acid 5 mg will be administered once weekly (Shafa Pharmaceutical and Hygienic Company).All patients will receive standard therapy, including intranasal fluticasone spray twice daily (Koushan Pharmed Company) and nasal and sinus irrigation with saline solution 1–2 times daily (SGALESH Nasal and Sinus Irrigation Solution).In case of severe exacerbation of symptoms, a short course (up to one week) of oral prednisolone (Aburaihan Pharmaceutical Company) may be prescribed. The dose and duration of prednisolone use will be recorded and considered in the data analysis. Control group: patients will receive placebo tablets matching oral methotrexate at a dose equivalent to 15 mg per week, administered as divided doses on two consecutive days (Thursday and Friday) for a duration of 12 weeks. The placebo tablets will be prepared to resemble Trexoma 2.5 mg tablets manufactured by Nano Alvand Pharmaceutical Nanotechnology Company. Additionally, folic acid 5 mg will be prescribed once weekly. The folic acid used in this study is manufactured by Shafa Pharmaceutical and Hygienic Company. All patients will also receive standard therapy, including intranasal fluticasone spray twice daily manufactured by Koushan Pharmed Company, and nasal and sinus irrigation with saline solution one to two times daily using SGALESH Nasal and Sinus Irrigation Solution. In case of severe exacerbation of symptoms, oral prednisolone manufactured by Aburaihan Pharmaceutical Company may be prescribed for a short course of up to one week. The dose and duration of prednisolone use will be carefully recorded and considered in the data analysis. 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. 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. Ahvaz University of Medical Sciences Approved 2026-02-21 Ethical Committee of Ahvaz Jundishapur University of Medical Sciences College Town, Golestan Ahvaz Khouzestan Iran (Islamic Republic of)