A Randomized Placebo-Controlled Clinical Trial of an Innovative Herbal Formula for Atopic Dermatitis in Children: Evaluations of Modified Qing-Ying Decoction on Efficacy and Gut Microbiome
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Eczema Area and Severity Index (EASI)
研究概览
简要总结
The study aims to evaluate the clinical efficacy and safety of the modified Qing-Ying Decoction (mQYD) for the treatment of subacute and chronic atopic dermatitis (AD) in children when compared to the placebo control through examining the clinical symptoms, quality of life, gut microbiome, and Chinese medicine body constitution.
This is a parallel, randomized, placebo-controlled, double-blind clinical trial. Eligible subjects will be randomly allocated to receive oral mQYD granules or it's placebo granules. Subjects will have 12-week of treatment, and then a 4-week follow-up.
详细描述
The subjects will come for a screening visit at week 0 (baseline), then at week 6, week 12, and week 16 for Chinese medicine practitioner (CMP) investigators assessments. Eczema Area and Severity Index (EASI), Children's Dermatology Life Quality Index (CDLQI), Patient-Oriented Eczema Measure (POEM), and Chinese Medicine body constitution types will be assessed and filled up at different timepoints. They will receive oral herbal mQYD or placebo granules for 12 weeks and then be followed up 4 weeks after the treatment. Registered CMPs will provide consultation under Chinese medicine theory. Study medication compliance and adverse events will also be assessed at each visit. Besides, they need to record the food taken in a diary before the day for taking faecal specimen for gut microbiome analysis.
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 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; and
- •Has taken anti-coagulant or anti-platelet drugs in the past month.
- •Has taken any probiotics, prebiotics in the last month
- •Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
研究组 & 干预措施
Modified Qing-Ying Decoction
Herbal granules, twice per day for 12 weeks
干预措施: Modified Qing-Ying Decoction (Drug)
Identical looking placebo
Placebo granules, twice per day for 12 weeks
干预措施: Identical looking placebo (Drug)
结局指标
主要结局
Eczema Area and Severity Index (EASI)
时间窗: 16 weeks
Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis
次要结局
- Constitution of Chinese Medicine Questionnaire (CCMQ)(16 weeks)
- Children's Dermatology Life Quality Index (CDLQI)(16 weeks)
- Patient Oriented Eczema Measure (POEM)(16 weeks)
研究者
Prof. Lin Zhixiu
Associate professor
Chinese University of Hong Kong