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Completed
NCT07630571
Efficacy of Oral HA35 for Rapid Relief of Oral Pain and Pungent Sensation
Conditions: Oral Pain, Oral Pungent Sensation, Capsaicin-Induced Pain, AITC-Induced Irritation, Oral Mucosa Discomfort
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: Nakhia Impex LLC
Location: HA35 Qingdao Shandong
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.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT07630571). StuddyBuddy aggregates publicly available trial information.
