A Randomized Placebo-Controlled Pilot Study of an Herbal Formula Modified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- EASI score
研究概览
简要总结
The study aims to evaluate the clinical efficacy of Chinese medicine (CM) for the treatment of subacute and chronic Atopic Dermatitis (AD) patients when compared to the placebo control by examining the clinical symptoms.
详细描述
This is a parallel, randomized, placebo-controlled, double-blind pilot study. The subjects will come for a screening visit at week 0 (baseline), then at week 6±3 days, week 12±3 days and week 16±4 days for Chinese medicine practitioner (CMP) investigators' assessments (Fig 1). Eczema Area and Severity Index (EASI), Children's dermatology life quality index (CDLQI), and Patient-Oriented Eczema Measure (POEM) will be assessed and filled up at different time points. Eligible subjects will be randomly allocated to the treatment group receiving oral CM granules or the placebo control group receiving oral placebo granules for 12 weeks, and then be followed up 4 weeks after the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 4 to 17 (Chinese only);
- •With EASI ≥ 10;
- •Subacute and chronic atopic dermatitis presenting with dry, scaly, erythematous papules and plaques; and
- •Provide a written informed consent form (signed by one of their parents)
排除标准
- •History of allergy to Chinese medicines;
- •AD with Yang deficiency in syndrome differentiation, such as pale looking, always feeling cold, fatigue, chronic diarrhea with loose stool, urinary disorders such as urinary difficulty, excessive urination or incontinence
- •Known overt bacterial infections in the skin;
- •Known pregnancy;
- •Known severe medical conditions, such as cardiovascular, liver or renal dysfunction or Diabetes Mellitus;
- •Having used oral corticosteroids, oral antibiotics, other immunosuppressive or any preparation of oral herbal medicines for the treatment of AD in the past month;
- •Having been diagnosed with scabies, allergic contact dermatitis, seborrheic dermatitis or psoriasis;
- •Has taken anti-coagulant or anti-platelet drugs in the past month;
- •Has taken any probiotics, prebiotics in the last month; and
- •Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
研究组 & 干预措施
Active treatment (Modified Huang-Lian-Jie-Du Decoction (MHLJDD))
Chinese medicine
干预措施: Modified Huang-Lian-Jie-Du Decoction (MHLJDD) (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
EASI score
时间窗: 12 weeks
The change of EASI score for atopic dermatitis at week 12 Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis.
次要结局
- EASI score(16 weeks)
- CDLQI score(16 weeks)
- Time of flare(16 weeks)
- Microbiome(12 weeks)
- Trans-epidermal water loss (TEWL)(16 weeks)
- The number of subjects reaches flare(16 weeks)
- Adverse event(16 weeks)
- POEM score(16 weeks)
- Skin hydration (SH)(16 weeks)
- EASI score(6 weeks)
- CDLQI score(12 weeks)
- POEM score(12 weeks)
- Trans-epidermal water loss (TEWL)(6 weeks)
- Trans-epidermal water loss (TEWL)(12 weeks)
- Skin hydration (SH)(6 weeks)
- Skin hydration (SH)(12 weeks)
研究者
Prof. Lin Zhixiu
Professor
Chinese University of Hong Kong