Oral PainNCT07630571
Efficacy of Oral HA35 for Rapid Relief of Oral Pain and Pungent Sensation
A study testing Capsaicin Oral Challenge, Allyl Isothiocyanate (AITC) Oral Challenge and 10% 35 kDa Hyaluronan (HA35) Oral Solution in people with Oral Pain and Oral Pungent Sensation, run by Nakhia Impex LLC at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Pain, Oral Pungent Sensation, Capsaicin-Induced Pain
- What is being tested?
- Capsaicin Oral Challenge, Allyl Isothiocyanate (AITC) Oral Challenge and 10% 35 kDa Hyaluronan (HA35) Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2026to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years, healthy adults
- Able to tolerate capsaicin/AITC oral challenge
- Able to complete NRS assessments
- Signed informed consent
Who cannot join
- Oral ulcers, lesions, or mucosal disease
- Known hyaluronan allergy
- Severe systemic disease
- Pregnancy/lactation
- Recent oral analgesic use (≤24h)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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，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.
Read the 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.
- Conditions
- Oral Pain, Oral Pungent Sensation, Capsaicin-Induced Pain, AITC-Induced Irritation, Oral Mucosa Discomfort
- Being tested
- Capsaicin Oral Challenge, Allyl Isothiocyanate (AITC) Oral Challenge, 10% 35 kDa Hyaluronan (HA35) Oral Solution, 4 mg/L C60 in Grapeseed Oil, 0.9% Normal Saline
- Keywords
- Hyaluronan, 35 kDa Hyaluronan, HA35, Oral Solution, Rapid Analgesia, Oral Pain Relief, Capsaicin, AITC, Wasabi/Horseradish Relief, Pilot Clinical Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin Oral ChallengeOther
Also called HA35 Oral Pain Relief Solution; Anti-Pungent Oral HA35 Solution
A standardized oral capsaicin challenge administered to induce transient oral pain and pungent sensation before the assigned oral intervention.
Allyl Isothiocyanate (AITC) Oral ChallengeOther
A standardized oral allyl isothiocyanate (AITC) challenge administered to induce transient oral pain and pungent/irritant sensation before the assigned oral intervention.
10% 35 kDa Hyaluronan (HA35) Oral SolutionOther
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.
4 mg/L C60 in Grapeseed OilOther
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.
0.9% Normal SalineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Allyl Isothiocyanate (AITC) Oral Challenge; Other: 0.9% Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 30 seconds, 60 seconds, and 120 seconds after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start5 Jun 2026
- Primary completion30 Jun 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nakhia Impex LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630571
- Sponsor's protocol ID
- HA35202610
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07630571
- Acronym / sponsor ID
- HA35202610
- Conditions
- Oral Pain, Oral Pungent Sensation, Capsaicin-Induced Pain, AITC-Induced Irritation, Oral Mucosa Discomfort
- Keywords
- Hyaluronan, 35 kDa Hyaluronan, HA35, Oral Solution, Rapid Analgesia, Oral Pain Relief, Capsaicin, AITC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nakhia Impex LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 辣椒素挑战+10%35kDa透明质酸（HA35） | Experimental | Other: Capsaicin Oral Challenge, Other: 10% 35 kDa Hyaluronan (HA35) Oral SolutionParticipants 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. |
| 辣椒素挑战+4毫克/升C60葡萄籽油 | Active comparator | Other: Capsaicin Oral Challenge, Other: 4 mg/L C60 in Grapeseed OilParticipants 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. |
| 辣椒素挑战+0.9%正常生理盐水 | Placebo comparator | Other: Capsaicin Oral Challenge, Other: 0.9% Normal SalineParticipants 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. |
| AITC挑战+10%35kDa透明质酸（HA35） | Experimental | Other: Allyl Isothiocyanate (AITC) Oral Challenge, Other: 10% 35 kDa Hyaluronan (HA35) Oral SolutionParticipants 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. |
| AITC挑战+4毫克/升C60葡萄籽油 | Active comparator | Other: Allyl Isothiocyanate (AITC) Oral Challenge, Other: 4 mg/L C60 in Grapeseed OilParticipants 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. |
| AITC挑战+0.9%正常盐水 | Placebo comparator | Other: Allyl Isothiocyanate (AITC) Oral Challenge, Other: 0.9% Normal SalineParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years, healthy adults
- Able to tolerate capsaicin/AITC oral challenge
- Able to complete NRS assessments
- Signed informed consent
Key exclusion criteria (5 listed)
- Oral ulcers, lesions, or mucosal disease
- Known hyaluronan allergy
- Severe systemic disease
- Pregnancy/lactation
- Recent oral analgesic use (≤24h)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaicin Oral ChallengeAlso: HA35 Oral Pain Relief Solution; Anti-Pungent Oral HA35 SolutionA standardized oral capsaicin challenge administered to induce transient oral pain and pungent sensation before the assigned oral intervention. | Other | 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 ChallengeA standardized oral allyl isothiocyanate (AITC) challenge administered to induce transient oral pain and pungent/irritant sensation before the assigned oral intervention. | Other | 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 |
| 10% 35 kDa Hyaluronan (HA35) Oral Solution20 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. | Other | AITC挑战+10%35kDa透明质酸（HA35）, 辣椒素挑战+10%35kDa透明质酸（HA35） |
| 4 mg/L C60 in Grapeseed Oil20 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. | Other | 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 Saline20 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. | Other | AITC挑战+0.9%正常盐水, 辣椒素挑战+0.9%正常生理盐水 |
Primary outcome
Change in Oral and Upper-Airway Discomfort Intensity After Horseradish Stimulation (0-10 NRS)
Time frame: 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)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsaicin Oral Challenge, Allyl Isothiocyanate (AITC) Oral Challenge and 10% 35 kDa Hyaluronan (HA35) Oral Solution in people with Oral Pain and Oral Pungent Sensation, run by Nakhia Impex LLC at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oral and Upper-Airway Discomfort Intensity After Horseradish Stimulation (0-10 NRS) (time frame: Baseline and 3 seconds and 30 seconds after treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.