Atopic dermatitis - adult type Skin and Connective Tissue Diseases Atopic dermatitis
Conditions
Interventions
This is a randomised, double-blind, placebo-controlled, multi-centre trial study. Participants will receive hwangryunhaedoktang or a placebo-drug for 8 weeks. Oral administration occurs according to t
they take a packet of the medicine (5.00g) with tepid water for three times a day after meal
2. Patients in group 2 receive the placebo medicine (powdered extract) used in the same way as with group 1
Sponsors
Korea Health Industry Development Institute (KHIDI)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age greater than 19 years, either sex 2. Typical conditions of intermittent or continuous atopic eczema 2.1. Duration of more than 6 months 2.2. Satisfied Hanifin and Rajka?s criteria for atopic dermatitis 3. Diagnosed with adult atopic dermatitis by two different oriental medicine doctors 4. Written and informed consent
Exclusion criteria
Exclusion criteria: 1. Other dermatitis or systemic disease except for atopic eczema 2. Administration of steroids and immunosuppressant per os (by mouth) within one week from the interview (topical application not relevant) 3. Women who are pregnant, lactating or without contraception 4. Clinical severe hepatic disease or abnormal liver function tests at least twice the upper limit of normal 5. Other clinical trial within the last 1 month 6. Hypersensitivity or allergy of drugs 7. Disease which can affect the absorption of drugs or disordered digestion after surgery related to the disease 8. Cannot understand written consent or follow this study: 8.1. Mental retardation 8.2. Mental or emotional problems 9. Judged by expert as inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Efficacy: SCORing Atopic Dermatitis index (SCORAD): the purpose of this questionnaire is to identify the lesional, symptomatic, subjective severities. Measured at treatment period (treatment initiation, 2·4·8 weeks later of first medication) 2. Safety: 2.1. Complete Blood Cell Cound (CBC) 2.2. Erythrocyte Sedimentation Rate (ESR) 2.3. Blood chemistry 2.4. Urine analysis 2.5. Chest-PA film Measured at baseline, 8 weeks after first medication 2.6. Vital signs, measured at baseline, treatment period (treatment initiation, 2, 4, 8 weeks after first medication) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 1. Total IgE 2. Eosinophil count Measured at treatment initiation, 4 and 8 weeks after first medication 3. EuroQol 5-Dimension (EQ-5D) 4. Health Utilities Index Mark 3 (HUI-3) 5. Dermatology Life Quality Index (DLQI) Measured at treatment initiation, 8 weeks after first medication | — |
Countries
Korea, South
Outcome results
None listed