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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Oral and Upper-Airway Discomfort Intensity After Horseradish Stimulation (0-10 NRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years, healthy adults
- •Able to tolerate capsaicin/AITC oral challenge
- •Able to complete NRS assessments
- •Signed informed consent
排除标准
- •Oral ulcers, lesions, or mucosal disease
- •Known hyaluronan allergy
- •Severe systemic disease
- •Pregnancy/lactation
- •Recent oral analgesic use (≤24h)
研究组 & 干预措施
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.
干预措施: Capsaicin Oral Challenge (Other)
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.
干预措施: 10% 35 kDa Hyaluronan (HA35) Oral Solution (Other)
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.
干预措施: Capsaicin Oral Challenge (Other)
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.
干预措施: 4 mg/L C60 in Grapeseed Oil (Other)
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.
干预措施: Capsaicin Oral Challenge (Other)
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.
干预措施: 0.9% Normal Saline (Other)
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.
干预措施: Allyl Isothiocyanate (AITC) Oral Challenge (Other)
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.
干预措施: 10% 35 kDa Hyaluronan (HA35) Oral Solution (Other)
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.
干预措施: Allyl Isothiocyanate (AITC) Oral Challenge (Other)
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.
干预措施: 4 mg/L C60 in Grapeseed Oil (Other)
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.
干预措施: Allyl Isothiocyanate (AITC) Oral Challenge (Other)
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.
干预措施: 0.9% Normal Saline (Other)
结局指标
主要结局
Change in Oral and Upper-Airway Discomfort Intensity After Horseradish Stimulation (0-10 NRS)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点