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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，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.
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
2026-06-05
Completion Date
2026-07-10
Last Updated
2026-09-10
Healthy Volunteers
Yes
Conditions
Interventions
Capsaicin Oral Challenge
A standardized oral capsaicin challenge administered to induce transient oral pain and pungent sensation before the assigned oral intervention.
Allyl Isothiocyanate (AITC) Oral Challenge
A standardized oral allyl isothiocyanate (AITC) challenge administered to induce transient oral pain and pungent/irritant sensation before the assigned oral intervention.
10% 35 kDa Hyaluronan (HA35) Oral Solution
20 mL oral solution containing 10% 35 kDa hyaluronan (HA35). The solution is held in the mouth for 3-30 seconds and then swallowed following the assigned oral challenge.
4 mg/L C60 in Grapeseed Oil
20 mL preparation containing 4 mg/L C60 fullerene in grapeseed oil. The preparation is held in the mouth for 3-30 seconds and then swallowed following the assigned oral challenge.
0.9% Normal Saline
20 mL of 0.9% sodium chloride solution. The solution is held in the mouth for 3-30 seconds and then swallowed following the assigned oral challenge.
Locations (1)
HA35
Qingdao, Shandong, China