About this trial
This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of nasopharyngeal administration of 13.6% high-concentration 35 kDa hyaluronan (HA35) care gel in subjects with chronic rhinitis and chronic pharyngitis. Eligible participants will receive the study gel twice daily for 10 consecutive days. The primary objectives are to assess rapid changes in nasopharyngeal discomfort, posterior pharyngeal discomfort, and nasal obstruction within 30 minutes after the first administration. Secondary objectives include evaluation of overall symptom improvement at day 10, changes in subjective mental clarity, and safety and tolerability throughout the treatment period. This is a minimal-risk, non-pharmacological supportive care intervention.
Eligibility criteria
Qualifiers
Age 18-80 years, male or female
Clinically diagnosed with chronic rhinitis and chronic pharyngitis for ≥3 months
Baseline nasopharyngeal discomfort NRS score ≥4 points
Baseline posterior pharyngeal discomfort NRS score ≥4 points
Disqualifiers
Acute upper respiratory tract infection within 2 weeks
Use of antihistamines, intranasal corticosteroids, decongestants, or other nasal medications within 2 weeks prior to screening
History of nasal/sinus surgery within 6 months
Known hypersensitivity to hyaluronan or any gel ingredients
Trial design
Treatments tested in this trial
- 13.6% High-Concentration 35 kDa Hyaluronan (HA35) Nasopharyngeal Care Gel