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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 13.6% High-Concentration 35 kDa Hyaluronan (HA35) Nasopharyngeal Care Gel

    Device

    A topical, non-pharmacological nasopharyngeal care gel containing 13.6% high-concentration 35 kDa hyaluronan. It is designed to support mucosal hydration and reduce inflammation in the nasopharynx. Administration is via direct nasopharyngeal application, twice daily for 10 consecutive days.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: HA35 Nasopharyngeal Care Gel Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Posterior Pharyngeal Discomfort and Cough NRS Score (0-10)

Change in posterior pharyngeal discomfort and associated cough intensity, measured using a 0-10 Numeric Rating Scale (NRS), where 0 = no discomfort/cough and 10 = worst imaginable discomfort/cough.

Time frame
Baseline to 30 minutes after first administration

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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