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

Study acronym: HA35
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Completed without a posted recruiting period
    • Eligibility criteria expanded, about 12 words
  2. Study title shortened, about 4 wordsv2
  3. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07568548
Lead Sponsor Nakhia Impex LLC
Conditions
(from sponsor)		 Chronic Rhinitis, Chronic Pharyngitis, Nasopharyngitis, Posterior Pharyngeal Inflammation, Nasal Obstruction
Related terms Nasal Obstruction, Nasopharyngitis
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov