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Clinical Trials/TCTR20230310001
TCTR20230310001
Not yet recruiting
Phase 3

Efficacy of Intranasal corticosteroid spray versus placebo in post-operative endoscopic sinus surgery of patient with sinus fungal ball, Multi-center double blind randomized placebo controlled trials

Otolaryngology department, Ramathibodi hospital, Mahidol university0 sites65 target enrollmentStarted: March 10, 2023Last updated:

Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Otolaryngology department, Ramathibodi hospital, Mahidol university
Enrollment
65

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 Years to 80 Years (—)
Sex
All

Inclusion Criteria

  • 1\. Age equal or more than 18 years old
  • 2\. Imaging and intra\-operative sinuses finding associated with sinus fungal ball
  • 3\. Patient consent to join the research project

Exclusion Criteria

  • 1\. Pathology show invasive fungal sinusitis
  • 2\. Previous sinus surgery
  • 3\. Previous radiation therapy at head and neck
  • 4\. Having underlying diseases such as Ciliary dyskinesia, Cystic fibrosis
  • 5\. Taking immunosuppressive drugs
  • 6\. Patient with allergic rhinitis who need to regularly use intranasal corticosteroid
  • 7\. Patient who taking these drug before surgery
  • 7\.1\. Oral or IV corticosteroid 4 weeks
  • 7\.2\. Topical corticosteroid 2 weeks
  • 7\.3\. Intramuscular corticosteroid 4 week

Investigators

Sponsor
Otolaryngology department, Ramathibodi hospital, Mahidol university

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