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Efficacy of Oral HA35 for Rapid Relief of Oral Pain and Pungent Sensation

NCT07630571 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-10

No results posted yet for this study

Summary

This prospective, open-label, controlled pilot study evaluates oral 10% 35 kDa hyaluronan (HA35) versus four control interventions (C60 grapeseed oil，normal saline) for relief of capsaicin/AITC-induced oral pain and pungent sensation. Healthy participants receive standardized pain induction followed by single oral intervention. Pain/pungency assessed at 30 sec/60 sec/120 sec. Safety monitored throughout. Minimal-risk, non-invasive oral study.

Conditions

  • Oral Pain
  • Oral Pungent Sensation
  • Capsaicin-Induced Pain
  • AITC-Induced Irritation
  • Oral Mucosa Discomfort

Interventions

OTHER

10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Solution

Oral solution containing 10% high-concentration 35 kDa hyaluronan fragments. Administered orally/buccally for rapid relief of capsaicin/AITC-induced oral pain and pungent sensation.

OTHER

4 mg/L C60 Grapeseed Oil Oral Solution

Oral solution containing 4 mg/L C60 fullerene in grapeseed oil. Administered orally/buccally as a control for capsaicin/AITC-induced oral pain and pungent sensation.

OTHER

0.9% Normal Saline

0.9% sodium chloride (normal saline) administered orally/buccally as a placebo control for capsaicin/AITC-induced oral pain and pungent sensation.

Sponsors & Collaborators

  • Nakhia Impex LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-05
Primary Completion
2026-06-30
Completion
2026-07-10

Countries

  • China

Study Locations

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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 NCT07630571 on ClinicalTrials.gov