Comparison of the effect of Budesonide nasal spray, Betamethasone nasal drop, and Budesonide nebulizing suspension on sinonasal polyposis recurrence

Comparative assessment of the effect of corticosteroid in three forms of Budesonide nasal spray, Betamethasone nasal drop, and Budesonide nebulizing suspension on sinonasal polyposis recurrence after the FESS

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201021049095N1

Enrollment

108

Registered

2021-09-29

Start date

2021-09-23

Completion date

Unknown

Last updated

2021-11-01

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

Conditions

Sinonazal polyposis. Nasal polyp, unspecified

Interventions

Intervention 1: Intervention group: Betamethasone nasal drop 0.1%- Daroopakhsh Company (3 drops on each side of the nose, once per night). In addition, Cephalexin and Lavage serum are given to the pat

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: FESS candidates with sinonasal polyposis patients between 18 to 70 years old

Exclusion criteria

Exclusion criteria: Absence of underlying diseases, including CF, Wegener's, Kartagener, sarcoidosis, vasculitis, or rheumatic diseases; Receiving no systemic corticosteroids for up to 4 weeks before surgery; ages below 18 or higher than 70 years olds

Design outcomes

Primary

Measure	Time frame
Recurrence. Timepoint: 1 and 6 months after surgery. Method of measurement: Diagnostic endoscopy.;Degree of recurrence. Timepoint: 1 and 6 month after surgery. Method of measurement: Modified L K –SCALE endoscopy.;Visual Analog Scale (VAS) for scoring the symptoms of sinusitis and polyps. Timepoint: 1 and 6 months post operation. Method of measurement: questioning from patients.;Self rated satisfaction of surgery outcomes. Timepoint: 1 and 6 months post surgery. Method of measurement: questioning from patients.;Need to revision. Timepoint: 1 and 6 months post surgery. Method of measurement: examination and questioning from patients.	—

Measure

Time frame

Recurrence. Timepoint: 1 and 6 months after surgery. Method of measurement: Diagnostic endoscopy.;Degree of recurrence. Timepoint: 1 and 6 month after surgery. Method of measurement: Modified L K –SCALE endoscopy.;Visual Analog Scale (VAS) for scoring the symptoms of sinusitis and polyps. Timepoint: 1 and 6 months post operation. Method of measurement: questioning from patients.;Self rated satisfaction of surgery outcomes. Timepoint: 1 and 6 months post surgery. Method of measurement: questioning from patients.;Need to revision. Timepoint: 1 and 6 months post surgery. Method of measurement: examination and questioning from patients.

—

Secondary

Measure	Time frame
Side effects including dryness and Epistaxis. Timepoint: 1 and 6 months after surgery. Method of measurement: clinical examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNajmeh Rajabi

Shahid Beheshti University of Medical Sciences

najmeh.rajabi@gmail.com+98 21 2243 2560

Outcome results

None listed

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