The Efficacy of Patients With Moderate to Severe Atopic Dermatitis Treated With Chinese Herbal Medicine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Changes of SCORing Atopic Dermatitis(SCORAD) Index
研究概览
简要总结
Conduct a clinical trial of integration of Chinese and Western medicine to evaluate whether the association of traditional Chinese medicine therapy has a remission effect on atopic dermatitis, and to explore the remission of lesions after an association of Chinese herbal medicine, and the correlation of syndrome differentiation types before and after treatment with Chinese and Western medicine, with a view to better understand the efficacy of atopic dermatitis in the treatment of the same disease in Traditional Chinese Medicine, and provide another option for patients with atopic dermatitis.
详细描述
This examination will be posted at Taipei Veterans General Hospital to recruit 24 participants who meet the inclusion criteria of atopic dermatitis to do the study. After participants agreeing to the clinical study and signing the consent form, the investigators are going to separate them into the A group (12 participants) and the B group (12 participants). The tests are going to take a total of 14 weeks.
Participants need to pass the international diagnostic criteria Hannifin and Rajka to be determined as patients with atopic dermatitis. After, participants need test by scoring Atopic Dermatitis Index (SCORAD) to be determined as mild to moderate atopic dermatitis and accept the Wang Qi Traditional Chinese Medical Constitutional Scale (TCMCS), dermatological quality of life index (DLQI) score or children's skin disease quality of life index (CDLQI) score, routine blood tests, liver and kidney function tests, immunological markers associated with atopic dermatitis Diagnosis of (eosinophils count, ECP, and IgE), tongue diagnosis, and pulse diagnosis. After the collection of data is completed, the investigators will be analyzing the data by SPSS version 21 as a two-paired t-test, ANOVA statistical method, and P <0.05 as a significant result.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 years old to 30 years old.
- •Diagnosis as an atopic dermatitis patient.
- •The score of the SCORAD is over
- •(moderate to severe atopic dermatitis)
排除标准
- •Secondary bacterial infections
- •Received oral or intravenous steroid treatment, anti-biotics, phototherapy, or other immunosuppressive therapies in the previous 2 months.
- •Received Chinese herbal medicine treatment or acupuncture.
- •Pregnant woman or current breastfeeding.
- •Who had catastrophes illness now or in the past must be avoided.
- •Can not sign informed consent or can not communicate with the researcher.
- •Abnormal liver enzymes.
- •Abnormal kidney function tests (1.5 times higher than the upper normal limit)
研究组 & 干预措施
Group A
Group A will receive Xiao-Xian-Gui-Fu-Tang(VGH4) for 6 weeks, then entry 2 weeks wash-out period. Then switch to receive the placebo for another 6 weeks.
干预措施: Xiao-Xian-Gui-Fu-Tang (Drug)
Group A
Group A will receive Xiao-Xian-Gui-Fu-Tang(VGH4) for 6 weeks, then entry 2 weeks wash-out period. Then switch to receive the placebo for another 6 weeks.
干预措施: Placebo (Drug)
Group B
Group B will receive placebo for 6 weeks, then entry 2 weeks wash-out period. Then switch to receive the Xiao-Xian-Gui-Fu-Tang (VGH4)for another 6 weeks.
干预措施: Xiao-Xian-Gui-Fu-Tang (Drug)
Group B
Group B will receive placebo for 6 weeks, then entry 2 weeks wash-out period. Then switch to receive the Xiao-Xian-Gui-Fu-Tang (VGH4)for another 6 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes of SCORing Atopic Dermatitis(SCORAD) Index
时间窗: week 0, 3, 6, 8, 11, 14
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). Dermatologists may use this tool before and after treatment to determine whether the treatment has been effective.
Changes of Dermatology Life Quality Index(DLQI)
时间窗: week 0, 3, 6, 8, 11, 14
The DLQI is designed to measure the health-related quality of life of adult patients suffering from a skin disease.
Changes of Children's Dermatology Life Quality Index(CDLQI)
时间窗: week 0, 3, 6, 8, 11, 14
The Children's Dermatology Life Quality Index (CDLQI) is designed to measure the impact of any skin disease on the lives of children.
次要结局
- Blood test (AST)(week 0, 6, 14)
- Changes of Constitution in Chinese Medicine Questionnaire(week 0, 6, 14)
- Blood test (ALT)(week 0, 6, 14)
- Blood test (Serum Creatinine)(week 0, 6, 14)