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IRCT20200708048051N5 IRCT 2026-06-10 Deputy of Research and Technology, Guilan University of Medical Sciences A Comparative Evaluation of the Effects of Betamethasone Drops versus Fluticasone Nasal Spray on Chronic Rhinosinusitis Following Endoscopic Sinus Surgery: A Randomized Controlled Trial A Comparative Evaluation of the Effects of Betamethasone Drops versus Fluticasone Nasal Spray on Chronic Rhinosinusitis Following Endoscopic Sinus Surgery: A Randomized Controlled Trial 2026-06-22 anticipated 80 Recruiting https://irct.ir/trial/90314 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method used for generating the randomization sequence, including the software or website used: To generate a randomization sequence with a unique code, the Sealed Envelope website was used . All eligible patients will be allocated to groups A and B in equal proportions (1:1) using stratified block randomization with block sizes of fou, Blinding description: Participants: Patients will be unaware of which treatment they are receiving (betamethasone drops or fluticasone spray). To maintain blinding, identical-looking containers will be used for both medications. Healthcare Providers/Investigators: Physicians and nurses administering the treatments and monitoring patients will also be blinded to the assigned intervention. This ensures that their assessments and interactions are not influenced by knowledge of the treatment. Outcome Assessors/Analysts: Individuals evaluating clinical outcomes, performing endoscopic scoring, and analyzing the data will remain blinded to group allocation until the completion of data analysis. Randomization codes will be securely held by a third-party (e.g., a statistician or independent coordinator) who will not participate in patient care or outcome assessment. Codes will be revealed only after the final analysis is completed. 2-3 CRSwNP patients. Intervention 1: Intervention group: The patient received intranasal betamethasone drops (three drops in the morning) together with saline spray as placebo, and intranasal fluticasone spray (two puffs at night). Intervention 2: Control group: : The patient received intranasal fluticasone spray, administered as two puffs every 12 hours, and saline drops (three drops in the morning), which were used as placebo. Yes - There is a plan to make this available What will be shared: Data will be shared comprehensively and will include all the variables mentioned above, not being limited to only the primary outcomes. Following the removal of all direct identifiers (such as name, medical record number, national identification code) and the application of ethical considerations, these data will be made available to researchers for legitimate research purposes When: The data and document access period will begin from the project's completion and after the initial results are published in a scientific article. This access will be available for a minimum of 5 years after the project's end date. To whom: Access to the de-identified data from this research will be provided to researchers and investigators affiliated with academic institutions, scientific research centers, or healthcare-therapeutic organizations. Requests for access must have a valid scientific justification and clear research objectives, and must be approved by an independent ethics review committee. This access does not include researchers working in industry (pharmaceutical or medical device industries), except within the framework of approved scientific collaborations with the university and with full adherence to ethical considerations and confidentiality preservation Conditions: The data and documents from this research will be accessible solely for research and academic purposes, including conducting secondary studies, meta-analyses, validation of findings, and educational objectives (with proper citation). Applicants must submit a written request along with a detailed research proposal and provide a certificate of approval from the ethics committee of their affiliated institution. Commercial use of the data in any form is not permitted, and the applicant is required to sign an agreement ensuring confidentiality, citing the original source in all publications, refraining from re-identifying participants, submitting draft manuscripts to the principal investigator prior to publication, not transferring data to third parties, and deleting the data upon project completion. All requests will be evaluated and subject to final decision by the Research Oversight Committee. Where to obtain: To access the data and documents from this research, applicants can submit their requests in order of priority via email to akbarpour_malihe@yahoo.com with the subject line "Request for Access to Chronic Rhinosinusitis Research Data" addressed to Dr. Malihe Akbarpour (Principal Investigator). If a telephone call is necessary, contact can be made at 09001311808 from Saturday to Wednesday between 10:00 and 14:00. Additionally, written requests can be sent by mail to the following address: Guilan Province, Rasht City, Amir al-Momenin Hospital, Otorhinolaryngology Research Center, Postal Code: [Exact postal code to be specified according to hospital protocol], Attn: Dr. Malihe Akbarpour. It should be noted that all requests must include a detailed research proposal, ethics committee approval, and complete contact information, with email communications receiving priority processing. All received requests will be reviewed and evaluated by the principal investigator and the Research Oversight Committee at Guilan University of Medical Sciences. How to obtain: The process for requesting access to the data from this research is a multi-stage procedure that typically takes 5 to 8 business weeks to complete. After the applicant submits a complete request (including the research proposal, ethics approval, and contact information), an initial review is conducted by the principal investigator. If necessary, supplementary correspondence will take place and a Data Use Agreement will be sent (1 to 2 weeks). The request is then referred to the Research Oversight Committee of Guilan University of Medical Sciences for scientific and ethical evaluation (2 to 4 weeks). Following final approval by the committee (1 week), if approved, the de-identified data will be delivered in processable file formats through secure methods (1 week). It should be noted that this timeframe may vary slightly depending on the volume of requests and the committee's meeting schedule. The status of the request can be followed up via email at akbarpour_malihe@yahoo.com. Comments:
public Hossein Ramzannejad
Amir al-Momenin Hospital, 17 Shahrivar Street, Rasht City, Iran
Rasht Iran (Islamic Republic of) 4193784751 +98 930 812 1552 ramzannejadh@gmail.com Rasht University of Medical Sciences scientific Hossein Ramzannejad
Amir al-Momenin Hospital, 17 Shahrivar Street, Rasht City, Iran
rasht Iran (Islamic Republic of) 4193784751 +98 13 3323 8306 ramzannejadh@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients aged 18–65 years sinonasal polyposis involving the frontal recess and bilateral ethmoid sinuses failed to respond to maximal medical therapy surgery candidate 18 years 65 years Both A prior history of endoscopic sinus surgery (ESS) History of smoking Systemic diseases such as granulomatosis with polyangiitis (GPA), eosinophilic granulomatosis with polyangiitis (EGPA), cystic fibrosis, and primary ciliary dyskinesia Hypothalamic–pituitary–adrenal (HPA) axis dysfunction "Central compartment disease (CCD) Chronic rhinosinusitis without nasal polyps (CRSsNP) Mucocele Previous skull base fracture Patients presenting with glaucoma and increased intracranial pressure (ICP) J32 Chronic sinusitis Treatment - Drugs Placebo Intervention group: The patient received intranasal betamethasone drops (three drops in the morning) together with saline spray as placebo, and intranasal fluticasone spray (two puffs at night). Control group: : The patient received intranasal fluticasone spray, administered as two puffs every 12 hours, and saline drops (three drops in the morning), which were used as placebo To evaluate the quality of life In two groups of patients with chronic sinusitis with polyposis, who respectively underwent 'endoscopic sinus surgery + fluticasone nasal spray' or 'endoscopic sinus surgery + fluticasone nasal spray + betamethasone nasal drops. Timepoint: Immediately before surgery, and at 3 and 6 months postoperatively". Method of measurement: Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire. Evaluate the degree of endoscopic disease involvement In two groups of patients with chronic sinusitis with polyposis, who respectively underwent 'endoscopic sinus surgery + fluticasone nasal spray' or 'endoscopic sinus surgery + fluticasone nasal spray + betamethasone nasal drops. Timepoint: Immediately before surgery, and at 3 and 6 months postoperatively. Method of measurement: The Lund–Kennedy endoscopic scoring system was used to evaluate endoscopic findings in patients with chronic rhinosinusitis. Assessment of the extent of involvement and radiologic staging of chronic rhinosinusitis. Timepoint: Immediately before surgery. Method of measurement: The Lund–Mackay scoring system was used to perform radiologic staging in patients with CRS. Lymphocyte cell. Timepoint: immediately before surgery, and at 2 and 6 months postoperatively. Method of measurement: The percentage of lymphocytes relative to the total WBC in a CBC test. Polymorphonuclear cell. Timepoint: immediately before surgery, and at 2 and 6 months postoperatively. Method of measurement: The percentage of Polymorphonuclear cell relative to the total WBC in a CBC test. WBC cell. Timepoint: immediately before surgery, and at 2 and 6 months postoperatively. Method of measurement: the total WBC in a CBC test. Cortisol level. Timepoint: immediately before surgery, and at 2 and 6 months postoperatively. Method of measurement: The basal serum cortisol level at 8:00 a.m. while fasting, for which the normal range is 1-25 micrograms per deciliter. ACTH Level. Timepoint: immediately before surgery, and at 2 and 6 months postoperatively. Method of measurement: The basal serum adrenocorticotropic hormone level at 8:00 a.m. while fasting, for which the normal range is 9 to 52 picograms per milliliter. IgE level. Timepoint: immediately before surgery, and at 2 and 6 months postoperatively. Method of measurement: International Unit per milliliter. Eosinophil cell. Timepoint: immediately before surgery, and at 2 and 6 months postoperatively. Method of measurement: The percentage of eosinophil cell relative to the total WBC in a CBC test. Deputy of Research and Technology, Guilan University of Medical Sciences Approved 2026-04-22 Research Ethics Committee of Guilan University of Medical Sciences Deputy of Research and Technology, Guilan University of Medical Sciences, Opposite 17 Shahrivar Hospital, Shahid Siyyadati Street, Namjoo Street, Rasht, Iran Rasht Guilan Iran (Islamic Republic of)