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Efficacy of Oral HA35 for Rapid Relief of Oral Pain and Pungent Sensation
Sponsor: Nakhia Impex LLC
Summary
This prospective, open-label, controlled pilot study evaluates oral 10% 35 kDa hyaluronan (HA35) versus four control interventions (C60 grapeseed oil, high-oxidation potential water, normal saline, grapeseed oil) 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 3 sec/30 sec/60 sec/90 sec. Safety monitored throughout. Minimal-risk, non-invasive oral study.
Official title: A Prospective, Single-Arm, Open-Label Pilot Clinical Study of Oral 10% 35 kDa Hyaluronan for Rapid Relief of Capsaicin/AITC-Induced Oral Pain and Pungent Sensation
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-05-20
Completion Date
2026-07-10
Last Updated
2026-08-04
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
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.
Locations (1)
HA35
Qingdao, Shandong, China