NCT07630571

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2026

Completed
Last Updated

June 5, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

May 22, 2026

Last Update Submit

June 1, 2026

Conditions

Oral PainOral Pungent SensationCapsaicin-Induced PainAITC-Induced IrritationOral Mucosa Discomfort

Keywords

Hyaluronan35 kDa HyaluronanHA35Oral SolutionRapid AnalgesiaOral Pain ReliefCapsaicinAITCWasabi/Horseradish ReliefPilot Clinical Study

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (5)

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.

Other: 10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Solution

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.

Other: 4 mg/L C60 Grapeseed Oil Oral Solution

High-Oxidation Potential Water

ACTIVE COMPARATOR

20 mL high-oxidation potential water. Held orally 3-10 seconds then swallowed.

Other: High-Oxidation Potential Water

0.9% Normal Saline

PLACEBO COMPARATOR

20 mL 0.9% normal saline. Held orally 3-10 seconds then swallowed.

Other: 0.9% Normal Saline

Pure Grapeseed Oil

PLACEBO COMPARATOR

20 mL pure grapeseed oil. Held orally 3-10 seconds then swallowed.

Other: Pure Grapeseed Oil

Interventions

10% High-Concentration 35 kDa Hyaluronan (HA35) Oral SolutionOTHER

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.

Also known as: HA35 Oral Pain Relief Solution; Anti-Pungent Oral HA35 Solution
10% 35 kDa Hyaluronan (HA35) Oral Solution
4 mg/L C60 Grapeseed Oil Oral SolutionOTHER

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.

4 mg/L C60 Grapeseed Oil Oral Solution
High-Oxidation Potential WaterOTHER

High-oxidation potential water administered orally/buccally as a control for capsaicin/AITC-induced oral pain and pungent sensation.

High-Oxidation Potential Water
0.9% Normal SalineOTHER

0.9% sodium chloride (normal saline) administered orally/buccally as a placebo control for capsaicin/AITC-induced oral pain and pungent sensation.

0.9% Normal Saline
Pure Grapeseed OilOTHER

Pure grapeseed oil administered orally/buccally as a control for capsaicin/AITC-induced oral pain and pungent sensation.

Pure Grapeseed Oil

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HA35

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Interventions

SolutionsSaline Solution

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsCrystalloid SolutionsIsotonic 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

May 20, 2026

Primary Completion

June 30, 2026

Study Completion

July 10, 2026

Last Updated

June 5, 2026

Record last verified: 2026-05

Locations

CN(1)