Clinical Trial

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

Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 changes
critical Trial completed 2026-08-05
critical Primary endpoint(s) modified 2026-08-05
notable Enrollment reduced: 50 -> 30 participants 2026-08-05
minor Trial arms changed: 5 -> 3 2026-08-05
Trial Details
NCT Number NCT07630571
Lead Sponsor Nakhia Impex LLC
Conditions Oral Pain, Oral Pungent Sensation, Capsaicin-Induced Pain, AITC-Induced Irritation, Oral Mucosa Discomfort
Enrollment 30 participants
Start Date 2026-06-05
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-07-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-10