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

NCT07568548 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-08

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Rhinitis
  • Chronic Pharyngitis
  • Nasopharyngitis
  • Posterior Pharyngeal Inflammation
  • Nasal Obstruction

Interventions

DEVICE

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

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.

Sponsors & Collaborators

  • Nakhia Impex LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-06-01
Completion
2026-07-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07568548 on ClinicalTrials.gov