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

June 1, 2026 updated by: Nakhia Impex LLC

A Prospective, Single-Arm, Open-Label Pilot Clinical Study of Oral 10% 35 kDa Hyaluronan for Rapid Relief of Capsaicin/AITC-Induced Oral Pain and Pungent Sensation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266000
        • HA35

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10% 35 kDa Hyaluronan (HA35) Oral Solution
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
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.
Other Names:
  • HA35 Oral Pain Relief Solution; Anti-Pungent Oral HA35 Solution
Active Comparator: 4 mg/L C60 Grapeseed Oil Oral Solution
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
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.
Active Comparator: High-Oxidation Potential Water
20 mL high-oxidation potential water. Held orally 3-10 seconds then swallowed.
Other: High-Oxidation Potential Water
High-oxidation potential water administered orally/buccally as a control for capsaicin/AITC-induced oral pain and pungent sensation.
Placebo Comparator: 0.9% Normal Saline
20 mL 0.9% normal saline. Held orally 3-10 seconds then swallowed.
Other: 0.9% Normal Saline
0.9% sodium chloride (normal saline) administered orally/buccally as a placebo control for capsaicin/AITC-induced oral pain and pungent sensation.
Placebo Comparator: Pure Grapeseed Oil
20 mL pure grapeseed oil. Held orally 3-10 seconds then swallowed.
Other: Pure Grapeseed Oil
Pure grapeseed oil administered orally/buccally as a control for capsaicin/AITC-induced oral pain and pungent sensation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oral Pain Intensity (0-10 NRS)
Time Frame: Baseline to 3 seconds, 30 seconds, 60 seconds, 90 seconds
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)
Time Frame: Baseline to 3 seconds, 30 seconds, 60 seconds, 90 seconds
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nakhia Impex LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 10, 2026

Study Registration Dates

First Submitted

May 22, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA35202610

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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