AITC-Induced Irritation, Capsaicin-Induced Pain, Oral Mucosa Discomfort, Oral Pain, Oral Pungent Sensation
Conditions
Keywords
Hyaluronan, 35 kDa Hyaluronan, HA35, Oral Solution, Rapid Analgesia, Oral Pain Relief, Capsaicin, AITC, Wasabi/Horseradish Relief, Pilot Clinical Study
Brief 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.
Detailed description
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.
Interventions
OTHERCapsaicin Oral Challenge
A standardized oral capsaicin challenge administered to induce transient oral pain and pungent sensation before the assigned oral intervention.
OTHERAllyl 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.
OTHER10% 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.
OTHER4 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.
OTHER0.9% 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.
Sponsors
Nakhia Impex LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-65 years, healthy adults * Able to tolerate capsaicin/AITC oral challenge * Able to complete NRS assessments * Signed informed consent
Exclusion criteria
* Oral ulcers, lesions, or mucosal disease * Known hyaluronan allergy * Severe systemic disease * Pregnancy/lactation * Recent oral analgesic use (≤24h)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oral and Upper-Airway Discomfort Intensity After Horseradish Stimulation (0-10 NRS) | Baseline and 3 seconds and 30 seconds after treatment. | 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. |
| Change in Oral Burning Pain Intensity After Chili Oil Stimulation (0-10 NRS) | Baseline and 30 seconds, 60 seconds, and 120 seconds after treatment. | 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. |
Countries
China
Outcome results
None listed