Oral Ginkgo Biloba and Narrow Band UVB in the Treatment of Vitiligo : A Randomized Double - Blind Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Repigmentation (more than 50% from baseline) as the primary outcome
研究概览
简要总结
Vitiligo is a common chronic skin disease with 1-4% prevalence. It has a significant psychosocial impact on patients and society. Different treatment modalities with variable success rates are available.
Phototherapy is among the successful treatments but gives modest results. Some reports documented the usefulness of Ginkgo Biloba (GB) when used alone in Vitiligo treatment.
详细描述
Adding GB to phototherapy, especially the most commonly used one; Narrow-Band UVB (NBUVB) might give better results than using either one alone. This might improve repigmentation as well as patients' quality-of-life. (QOL).
This will be a prospective double-blind randomized controlled clinical trial. One-hundred-sixty Vitiligo patients will be randomly divided into 2 groups( 80 patients per group).
One group will receive oral GB (2 tablets of 60 mgs twice daily) with NBUVB twice weekly.
The other group will receive placebo tablets( identical in size, shape and color) to GB twice daily with NBUVB twice weekly.
Both groups will be treated for 6 months. Standard protocol of phototherapy will be used for both groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any Vitiligo patient (age 12 years and above) with non-segmental Vitiligo.
- •Body surface area (BSA) involvement ≥ 3%.
排除标准
- •Unable to consent
- •Any topical, systemic or phototherapy for Vitiligo in the previous 2 months.
- •Pregnancy, breast feeding.
- •Liver or kidney disease.
- •Bleeding disorder or anticoagulant treatment
结局指标
主要结局
Repigmentation (more than 50% from baseline) as the primary outcome
时间窗: 3,6 and 9 months
次要结局
- Quality-of-life - as secondary outcome .(3,6 and 9 months)