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.
This prospective, single-center, open-label, controlled pilot clinical study evaluates the rapid analgesic and anti-pungent effects of oral 10% 35 kDa hyaluronan (HA35) compared with two control interventions in healthy adults with capsaicin/AITC-induced oral pain and pungent sensation. Eligible participants undergo standardized pain induction: Capsaicin (chili) challenge: Oral capsaicin exposure induces oral pain. AITC (wasabi/horseradish) challenge: Oral AITC exposure induces pain and pungency. After induction, participants are assigned to 6 parallel groups: HA35：20 mL 10% HA35 oral solution Control 1：20 mL 4 mg/L C60 grapeseed oil Control 2：20 mL normal saline All interventions administered orally, held 3-30 seconds then swallowed. Outcome assessments: Oral pain (0-10 NRS) Pungent/irritant sensation (0-10 NRS) Time points: Baseline, 30 sec, 60 sec, 120 sec Safety: Oral adverse events and tolerability monitored throughout. Minimal-risk, non-invasive oral intervention. All procedures follow Declaration of Helsinki; written informed consent obtained.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
A standardized oral capsaicin challenge administered to induce transient oral pain and pungent sensation before the assigned oral intervention.
A standardized oral allyl isothiocyanate (AITC) challenge administered to induce transient oral pain and pungent/irritant sensation before the assigned oral intervention.
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.
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.
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.
HA35
Qingdao, Shandong, China
Change in Oral and Upper-Airway Discomfort Intensity After Horseradish Stimulation (0-10 NRS)
Change in overall oral and upper-airway discomfort induced by commercially available horseradish, assessed using an 11-point Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain or irritation-related discomfort and 10 indicates the worst imaginable pain or irritation. The assessed sensation includes oral and lingual pain, nasal pungency, pharyngeal irritation, and cough-related discomfort.
Time frame: Baseline and 3 seconds and 30 seconds after treatment.
Change in Oral Burning Pain Intensity After Chili Oil Stimulation (0-10 NRS)
Change in oral burning pain induced by commercially available chili oil, assessed using an 11-point Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable oral pain.
Time frame: Baseline and 30 seconds, 60 seconds, and 120 seconds after treatment.
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