An Exploratory Study to Assess the Effect of Topical Application of Iodex® Balm on Local Surface Temperature Using Infra Red Thermal Imaging Technique
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Time to Significant Increase in Local Surface Temperature
研究概览
简要总结
The rationale of this study is to map out changes in temperature distribution brought about by topical application of our test product, and use this physiological phenomenon to visualize the onset of action involved in overall mechanism of action of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants suffering from chronic osteoarthritis of knee joint (as per American College of Rheumatology criteria) for > 3 months
- •Participants in good general and mental health with no clinically significant and relevant abnormalities of medical history or physical examination
排除标准
- •Women of child bearing potential, pregnant and lactating women
- •Intolerance/hypersensitivity to study material/ingredient
- •Recent history of alcohol or drug abuse
- •Participants receiving topical non-steroidal antiinflammatory drugs (NSAIDs), other topical analgesics/counterirritants/mineral oils, or other medication, which might interfere with study results
- •Participants having psoriasis/active atopic dermatitis/eczema/skin infected lesions/burn/wound at the site of application
研究组 & 干预措施
Test
2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint.
干预措施: IODEX® balm (Drug)
Placebo
2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint.
干预措施: Placebo balm (Other)
结局指标
主要结局
Time to Significant Increase in Local Surface Temperature
时间窗: Every minute from baseline to 10 minutes
Local surface temperature was measured by the spectral order of colour after application of product. Infra-red camera was used to take 11 images with one just before application of product and remaining 10 images at every minute for first 10 minutes after application of product. IR camera converted the IR energy radiated by the body into electrical impulses, which were then digitally indicated on a spatial temperature map. IR camera represents the temperature distribution in a so-called rainbow or spectral order of colors. The predominant colour will be determined on a 5 point scale based on Thermal Images produced using Infra-Red Thermography (IRT) technique and recorded as either Blue, Green, Yellow, Orange or Deep Orange/Red (In increasing order of temperature). There was an approximate temperature difference of 0.5°C between adjacent colours on the map which was supposed to brought about by application of the product and considered significant.
次要结局
未报告次要终点