Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 主要终点
- Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 12.
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract in treating nail psoriasis.
详细描述
Nail psoriasis treatment is notoriously difficult. While indigo naturalis has been demonstrated safe and effective in treating skin psoriasis, its effect on nail psoriasis remains unverified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Indigo naturalis extract in oil
Indigo naturalis extract in oil (INEO) was applied to the fingernails of one bilateral hand (experimental group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks.
干预措施: Indigo Naturalis Extract in Oil (Drug)
Olive oil
Olive oil was applied to the fingernails of the contra-lateral hand (control group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks.
干预措施: Indigo Naturalis Extract in Oil (Drug)
Olive oil
Olive oil was applied to the fingernails of the contra-lateral hand (control group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks.
干预措施: Olive Oil (Other)
结局指标
主要结局
Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 12.
时间窗: Baseline and Week 12
The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0.
Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 24.
时间窗: Baseline and Week 24
The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0.
次要结局
未报告次要终点
研究者
Yin-ku Lin
Chief of department of traditional Chinese medicine
Chang Gung Memorial Hospital