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The Efficacy of Buffered Hypertonic Saline with Budesonide Nasal Irrigation on Postoperative Endoscopic Sinus Surgery: A Randomized Controlled Trial

The Efficacy of Buffered Hypertonic Saline with Budesonide Nasal Irrigation on Postoperative Endoscopic Sinus Surgery: A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250525004
Enrollment
64
Registered
2025-05-25
Start date
2025-05-27
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Chronic Rhinosinusitis Nasal polyps Rhinosinusitis Nasal irrigation Hypertonic Saline Solutions Budesonide

Interventions

1 mg of budesonide and 9 grams of sodium chloride powder mixed with 3 grams of baking soda pure sodium bicarbonate in 500 ml of room temperature boiled water Nasal irrigation will be performed on post
Experimental Drug,Active Comparator Drug
Buffered hypertonic saline with budesonide ,Isotonic saline with budesonide

Sponsors

Faculty of Medicine Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 to 85 years 2. Patients was diagnosed with primary chronic rhinosinusitis according to EPOS 2020 guideline 3. Received bilateral endoscopic sinus surgery

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Revision surgery 3. Wegener, sarcoidosis, cystic fibrosis, Kartagener 4. Previous radiotherapy to sinonasal area 5. History of hypersensitivity to budesonide 6. Patients with severe glaucoma 7. Patients with hepatic failure 8. Patients with pituitary tumour

Design outcomes

Primary

MeasureTime frame
Severity of inflammatory burden 1, 2, 4 and 6 weeks Lund Kennedy score,Disease specific quality of life Base line, 1, 2, 4 and 6 weeks Thai SNOT-22

Secondary

MeasureTime frame
Nasal blockage Base line, 1, 2, 4 and 6 weeks VAS score,Alteration in sense of smell Base line, 1, 2, 4 and 6 weeks VAS score,Nasal discharge Base line, 1, 2, 4 and 6 weeks VAS score,Facial pain Base line, 1, 2, 4 and 6 weeks VAS score,Side effects Burning and dryness 1, 2, 4 and 6 weeks Record form

Countries

Thailand

Contacts

Public ContactParamee Leaungchairat

Faculty of Medicine Ramathibodi Hospital, Mahidol University

paramee.lea@mahidol.ac.th022011515

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026