Efficacy and Safety of High-Concentration 35 kDa Hyaluronan Gel for Chronic Nasopharyngitis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNakhia Impex LLC

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

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators