Psoriasis、Indigo Naturalis、Chinese Medicine Medicated Bath
关键词
抽象
描述
This is a single site, randomized, single-blind, controlled pilot study of Jing- Fu-Yau-Yu-Bau as a complementary therapy to treat mild to moderate plaque- type psoriasis during an 8-week period. We estimate to enroll 30 subjects (treatment group(N=15); controlled group(N=15)).
日期
最后验证: | 09/30/2019 |
首次提交: | 10/03/2019 |
提交的预估入学人数: | 10/03/2019 |
首次发布: | 10/06/2019 |
上次提交的更新: | 10/12/2019 |
最近更新发布: | 10/15/2019 |
实际学习开始日期: | 10/04/2019 |
预计主要完成日期: | 12/30/2019 |
预计完成日期: | 03/02/2020 |
状况或疾病
干预/治疗
Drug: chinese medicine medicated bath
Drug: Triamcinolone (Encort-A) 0.1%15g/Tube
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: chinese medicine medicated bath we used the leaf of paper mulberry as chinese medicine medicated bath. Two packs per day ,and the period of treatment will be two month. | Drug: chinese medicine medicated bath Topical steroids+paper mulberry leaf The botanical origin of paper mulberry leaf is Broussonetia papyrifera (L.) Vent. |
Active Comparator: control group Topical steroids |
资格标准
有资格学习的年龄 | 20 Years 至 20 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - 20-65 years, - had a diagnosis of plaque-type psoriasis for ≥6 months, - a Physician's Global Assessment (PGA) score of 2-3, <20% total body surface area (BSA) involvement, and a target plaque of ≥4 cm2. Exclusion Criteria: - non-plaque psoriasis, - rebound/flare of chronic psoriasis, - history of psoriatic arthritis, - current drug-induced psoriasis, - pregnant/nursing/planning pregnancy (men and women), - used biologics within 3 months or 5 times the half-life, - received phototherapy/systemic treatment within 4 weeks, - topicals within 2 weeks, - any systemic immunosuppressants within 4 weeks, -lithium/antimalarial/intramuscular gold within 4 weeks, - tested positive for HIV/hepatitis B/C, - had a history of alcohol/drug abuse, - clinically-significant laboratory abnormality, - sensitivity to Chinese herbs ,or allergy to leaf of paper mulberry. - had skin wound or skin infection - had current signs/symptoms of severe, progressive, or uncontrolled medical conditions, or were participating concurrently in an investigational study. |
结果
主要结果指标
1. participants achieving either a major clinical response or partial clinical response defind by Psoriasis Area Severity Index(PASI) over the 8 weeks treatment period. [baseline to 8 weeks]