Efficacy of Oral HA35 for Rapid Relief of Oral Pain and Pungent Sensation

NCT07630571 | Completed

• 1 other identifier: HA35202610
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Capsaicin-Induced Pain; Oral Mucosa Discomfort; Oral Pungent Sensation; AITC-Induced Irritation; Oral Pain

Keywords

Hyaluronan; 35 kDa Hyaluronan; HA35; Oral Solution; Rapid Analgesia; Oral Pain Relief; Capsaicin; AITC; Wasabi/Horseradish Relief; Pilot Clinical Study

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 30 seconds, 60 seconds, and 120 seconds after treatment.

Study Arms (6)

辣椒素挑战+10%35kDa透明质酸（HA35）

EXPERIMENTAL

Participants undergo standardized oral capsaicin challenge to induce oral pain and pungent sensation, followed by administration of 20 mL of 10% 35 kDa hyaluronan (HA35) oral solution. The solution is held in the mouth for 3-30 seconds and then swallowed.

Other: Capsaicin Oral Challenge; Other: 10% 35 kDa Hyaluronan (HA35) Oral Solution

辣椒素挑战+4毫克/升C60葡萄籽油

ACTIVE COMPARATOR

Participants undergo standardized oral capsaicin challenge to induce oral pain and pungent sensation, followed by administration of 20 mL of 4 mg/L C60 grapeseed oil oral solution. The solution is held in the mouth for 3-30 seconds and then swallowed.

Other: Capsaicin Oral Challenge; Other: 4 mg/L C60 in Grapeseed Oil

辣椒素挑战+0.9%正常生理盐水

PLACEBO COMPARATOR

Participants undergo standardized oral capsaicin challenge to induce oral pain and pungent sensation, followed by administration of 20 mL of 0.9% normal saline. The solution is held in the mouth for 3-30 seconds and then swallowed.

Other: Capsaicin Oral Challenge; Other: 0.9% Normal Saline

AITC挑战+10%35kDa透明质酸（HA35）

EXPERIMENTAL

Participants undergo standardized oral allyl isothiocyanate (AITC) challenge to induce oral pain and pungent sensation, followed by administration of 20 mL of 10% 35 kDa hyaluronan (HA35) oral solution. The solution is held in the mouth for 3-30 seconds and then swallowed.

Other: Allyl Isothiocyanate (AITC) Oral Challenge; Other: 10% 35 kDa Hyaluronan (HA35) Oral Solution

AITC挑战+4毫克/升C60葡萄籽油

ACTIVE COMPARATOR

Participants undergo standardized oral allyl isothiocyanate (AITC) challenge to induce oral pain and pungent sensation, followed by administration of 20 mL of 4 mg/L C60 grapeseed oil oral solution. The solution is held in the mouth for 3-30 seconds and then swallowed.

Other: Allyl Isothiocyanate (AITC) Oral Challenge; Other: 4 mg/L C60 in Grapeseed Oil

AITC挑战+0.9%正常盐水

PLACEBO COMPARATOR

Participants undergo standardized oral allyl isothiocyanate (AITC) challenge to induce oral pain and pungent sensation, followed by administration of 20 mL of 0.9% normal saline. The solution is held in the mouth for 3-30 seconds and then swallowed.

Other: Allyl Isothiocyanate (AITC) Oral Challenge; Other: 0.9% Normal Saline

Interventions

10% 35 kDa Hyaluronan (HA35) Oral Solution OTHER

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.

AITC挑战+10%35kDa透明质酸（HA35）; 辣椒素挑战+10%35kDa透明质酸（HA35）

Capsaicin Oral Challenge OTHER

A standardized oral capsaicin challenge administered to induce transient oral pain and pungent sensation before the assigned oral intervention.

Also known as: HA35 Oral Pain Relief Solution; Anti-Pungent Oral HA35 Solution

辣椒素挑战+0.9%正常生理盐水; 辣椒素挑战+10%35kDa透明质酸（HA35）; 辣椒素挑战+4毫克/升C60葡萄籽油

Allyl Isothiocyanate (AITC) Oral Challenge OTHER

A standardized oral allyl isothiocyanate (AITC) challenge administered to induce transient oral pain and pungent/irritant sensation before the assigned oral intervention.

AITC挑战+0.9%正常盐水; AITC挑战+10%35kDa透明质酸（HA35）; AITC挑战+4毫克/升C60葡萄籽油

4 mg/L C60 in Grapeseed Oil OTHER

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.

AITC挑战+4毫克/升C60葡萄籽油; 辣椒素挑战+4毫克/升C60葡萄籽油

0.9% Normal Saline OTHER

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.

AITC挑战+0.9%正常盐水; 辣椒素挑战+0.9%正常生理盐水

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years, healthy adults
• Able to tolerate capsaicin/AITC oral challenge
• Able to complete NRS assessments
• Signed informed consent

You may not qualify if:

• Oral ulcers, lesions, or mucosal disease
• Known hyaluronan allergy
• Severe systemic disease
• Pregnancy/lactation
• Recent oral analgesic use (≤24h)

Sponsors & Collaborators

• Nakhia Impex LLC: lead

Study Sites (1)

HA35

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Interventions

allyl isothiocyanate; 2,3,4-tri-O-acetylarabinopyranosyl isothiocyanate; Solutions; Fullerenes; Saline Solution

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Carbon; Elements; Inorganic Chemicals; Nanospheres; Nanoparticles; Nanostructures; Manufactured Materials; Technology, Industry, and Agriculture; Crystalloid Solutions; Isotonic Solutions

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 5, 2026
• Study Start: June 5, 2026
• Primary Completion: June 30, 2026
• Study Completion: July 10, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-05

Locations

CN (1)