eczema/atopic dermatitis
Conditions
Interventions
Control group:Placebo
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: RCT:1. Diagnosis of eczema/atpoic dermatitis;2. Diagnosis of dampness pattern in Chinese Medicine;3. aged 18-70 years;4. 1% < BSA < 10%;5. 1 <= IGA <= 3;6. Signed Informed consent. Observational study:1. aged 18-70;2. Diagnosis of non-dampness pattern in Chinese Medicine;3.Signed Informed consent.
Exclusion criteria
Exclusion criteria: RCT:1. Those with any uncontrolled cardiovascular, respiratory, digestive, urinary, hematological disease, known cancer or mental disease.2. Those who has ever used Huoxiang Zhengqi Oral Liquid for treating eczema/atopic dermatitis.3. Anyone allergic to any medicine or ingredients used in this study.4. Examination result shows that ALT or AST level exceeded 2 times of the higher range value; either total bilirubin or BUN level exceeded 1.5 times of the higher range value in screening period.5. Those who are pregnant, lactating, or who plan to become pregnant within 3 months.6. Medication used:(1) Systemic therapy with immunomodulatory or immunosuppressive agents (including tripterygium wilfordii) within 4 weeks;(2) Topical or systematic therapy with antibiotics or antihistamines within 2 weeks;(3) Phototherapy (such as PUVA, UVA or UVB) within 4 weeks;(4) Topical therapy with immunomodulator within 2 weeks;(5) Topical or systematic used any over-the-counter drugs within a week.7. Those who are participating in any clinical trial or had participated in clinical trial within a month.8. Those who are considered not appropriate to participate in this trial. Observational study:1.Those who are pregnant, lactating, or who plan to become pregnant;2. Those who are participating in any clinical trial or had participated in clinical trial within a month;3. Those who are considered not appropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema Area and Severity Index, EASI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Numerical rating scale, NRS;Investigator's Global Assessment, IGA;Body Surface Area,BSA;Skindex-29;EQ-5D-5L; | — |
Countries
China
Contacts
Public ContactZehuai Wen
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed