Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 four 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 5 parallel groups:
HA35:20 mL 10% HA35 oral solution Control 1:20 mL 4 mg/L C60 grapeseed oil Control 2:20 mL high-oxidation potential water Control 3:20 mL normal saline Control 4:20 mL grapeseed oil All interventions administered orally, held 3-10 seconds then swallowed.
Outcome assessments:
Oral pain (0-10 NRS) Pungent/irritant sensation (0-10 NRS) Time points: Baseline, 3 sec, 30 sec, 60 sec, 90 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10% 35 kDa Hyaluronan (HA35) Oral Solution | Experimental | 20 mL oral solution containing 10% 35 kDa hyaluronan fragments. Held orally 3-10 seconds then swallowed. |
|
| 4 mg/L C60 Grapeseed Oil Oral Solution | Active Comparator | 20 mL oral solution containing 4 mg/L C60 grapeseed oil. Held orally 3-10 seconds then swallowed. |
|
| High-Oxidation Potential Water | Active Comparator | 20 mL high-oxidation potential water. Held orally 3-10 seconds then swallowed. |
|
| 0.9% Normal Saline | Placebo Comparator | 20 mL 0.9% normal saline. Held orally 3-10 seconds then swallowed. |
|
| Pure Grapeseed Oil | Placebo Comparator | 20 mL pure grapeseed oil. Held orally 3-10 seconds then swallowed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Solution | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oral Pain Intensity (0-10 NRS) | Change in oral pain intensity induced by capsaicin/AITC, assessed by 0-10 Numeric Rating Scale (0 = no pain, 10 = worst pain). | Baseline to 3 seconds, 30 seconds, 60 seconds, 90 seconds |
| Change in Oral Pungent/Irritant Sensation (0-10 NRS) | Change in oral pungent/irritant sensation from capsaicin/AITC, assessed by 0-10 NRS (0 = no irritation, 10 = severe irritation). | Baseline to 3 seconds, 30 seconds, 60 seconds, 90 seconds |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HA35 | Qingdao | Shandong | 266000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 4 mg/L C60 Grapeseed Oil Oral Solution | Other | 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. |
|
| High-Oxidation Potential Water | Other | High-oxidation potential water administered orally/buccally as a control for capsaicin/AITC-induced oral pain and pungent sensation. |
|
| 0.9% Normal Saline | Other | 0.9% sodium chloride (normal saline) administered orally/buccally as a placebo control for capsaicin/AITC-induced oral pain and pungent sensation. |
|
| Pure Grapeseed Oil | Other | Pure grapeseed oil administered orally/buccally as a control for capsaicin/AITC-induced oral pain and pungent sensation. |
|
| ID | Term |
|---|---|
| D012996 | Solutions |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
Not provided
Not provided