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Efficacy and Safety of High-Concentration 35 kDa Hyaluronan Gel for Chronic Nasopharyngitis (HA35)

5. maj 2026 opdateret af: Nakhia Impex LLC

A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Topical 10% 35 kDa Hyaluronan (HA35) Gel for Ultra-Rapid Relief of Skin Pruritus

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This prospective, single-center, single-arm, open-label pilot clinical study is designed to investigate the efficacy and safety of a 13.6% high-concentration 35 kDa hyaluronan (HA35) nasopharyngeal care gel for the management of chronic rhinitis and chronic pharyngitis.

Participants meeting all eligibility criteria will receive the HA35 gel via nasopharyngeal administration, one unit per nostril, twice daily (morning and evening) for 10 consecutive days.

Symptom assessments will be performed at baseline, 30 minutes after the first administration, 1, 2, and 3 hours after the first morning dose, and on day 10. Assessments include numeric rating scales (NRS) for nasopharyngeal discomfort, posterior pharyngeal discomfort and cough, nasal airflow obstruction, overall rhinitis and pharyngitis symptom severity, and subjective mental clarity.

Safety evaluations will monitor all adverse events, local tolerability, and any unexpected reactions throughout the study period.

This study involves a non-invasive, non-pharmacological non-drug intervention with minimal risk to participants. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be obtained from all subjects prior to enrollment.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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
  • Voluntary participation and signed written informed consent
  • Ability to complete symptom assessment independently

Exclusion Criteria:

  • 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
  • Pregnant or lactating women
  • Severe systemic diseases or malignant tumors

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: HA35 Nasopharyngeal Care Gel Intervention Group
Participants will receive 13.6% high-concentration 35 kDa hyaluronan (HA35) nasopharyngeal care gel, administered via the nasopharyngeal route, one unit per nostril, twice daily (morning and evening) for 10 consecutive days. The intervention is non-pharmacological and designed to evaluate efficacy and safety in subjects with chronic rhinitis and chronic pharyngitis.
Enhed: 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.
Andre navne:
  • HA35 Nasopharyngeal Gel; HA35 Care Gel

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Posterior Pharyngeal Discomfort and Cough NRS Score (0-10)
Tidsramme: Baseline to 30 minutes after first administration
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.
Baseline to 30 minutes after first administration

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nakhia Impex LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. juni 2026

Studieafslutning (Anslået)

1. juli 2026

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HA35202601

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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