Efficacy of Oral HA35 for Rapid Relief of Oral Pain and Pungent Sensation
6. september 2026 oppdatert av: 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，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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Shandong
-
Qingdao, Shandong, Kina, 266000
- HA35
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 辣椒素挑战+10%35kDa透明质酸（HA35）
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.
|
A standardized oral capsaicin challenge administered to induce transient oral pain and pungent sensation before the assigned oral intervention.
Andre navn:
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.
|
|
Aktiv komparator: 辣椒素挑战+4毫克/升C60葡萄籽油
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.
|
A standardized oral capsaicin challenge administered to induce transient oral pain and pungent sensation before the assigned oral intervention.
Andre navn:
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.
|
|
Placebo komparator: 辣椒素挑战+0.9%正常生理盐水
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.
|
A standardized oral capsaicin challenge administered to induce transient oral pain and pungent sensation before the assigned oral intervention.
Andre navn:
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.
|
|
Eksperimentell: AITC挑战+10%35kDa透明质酸（HA35）
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.
|
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.
A standardized oral allyl isothiocyanate (AITC) challenge administered to induce transient oral pain and pungent/irritant sensation before the assigned oral intervention.
|
|
Aktiv komparator: AITC挑战+4毫克/升C60葡萄籽油
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.
|
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.
A standardized oral allyl isothiocyanate (AITC) challenge administered to induce transient oral pain and pungent/irritant sensation before the assigned oral intervention.
|
|
Placebo komparator: AITC挑战+0.9%正常盐水
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.
|
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.
A standardized oral allyl isothiocyanate (AITC) challenge administered to induce transient oral pain and pungent/irritant sensation before the assigned oral intervention.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Oral and Upper-Airway Discomfort Intensity After Horseradish Stimulation (0-10 NRS)
Tidsramme: 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.
|
Baseline and 3 seconds and 30 seconds after treatment.
|
|
Change in Oral Burning Pain Intensity After Chili Oil Stimulation (0-10 NRS)
Tidsramme: 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.
|
Baseline and 30 seconds, 60 seconds, and 120 seconds after treatment.
|
Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
5. juni 2026
Primær fullføring (Faktiske)
30. juni 2026
Studiet fullført (Faktiske)
10. juli 2026
Datoer for studieregistrering
Først innsendt
22. mai 2026
Først innsendt som oppfylte QC-kriteriene
1. juni 2026
Først lagt ut (Faktiske)
5. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. september 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Farmasøytiske preparater
- Uorganiske kjemikalier
- Krystalloidløsninger
- Isotoniske løsninger
- Elementer
- Produsert materiale
- Teknologi, industri og landbruk
- Karbon
- Nanostrukturer
- Nanopartikler
- Nanospheres
- Saltoppløsning
- Løsninger
- allyl isotiocyanat
- 2,3,4-tri-O-acetylarabinopyranosyl isothiocyanate
- Fullerenes
Andre studie-ID-numre
- HA35202610
Legemiddel- og utstyrsinformasjon, studiedokumenter
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