None listed
Conditions
Interventions
Drug : Experimental: So-cheong-ryong-tang (6.0g/day for participants aged 7~14, 9.0g/day for participants aged 15~65), 3 times a day, for 4 weeks, before each meal
Placebo Comparator: Placebo (6.0g/da
Sponsors
Wonkwang University. Iksan Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females aged 7-65 years with Scoring Atopic Dermatitis score between 15 and 49, exhibiting =3 main and =3 accessory symptoms based on the diagnostic criteria developed by Hanifin & Rajka 2) Participants with =1 box checked for respiratory symptoms, in the questionnaire survey for respiratory disorders 3) Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions (In the case of children, written consent is required from the children and the children’s parents)
Exclusion criteria
Exclusion criteria: 1)Patients receiving treatment for severe Atopic Dermatitis (such as antihistamines, adrenocortical hormones, or Korean traditional herbal medication) 2)Patients who have previously used oral antihistamines, steroids, antibiotics, systemic photochemotherapy, and other immune suppressants in the previous 4 weeks 3)Patients with systemic infection or under treatment with systemic antibiotics 4)Patients with severe dermatological disorders aside from Atopic Dermatitis, pigmentation, or large scarring of the area affected by Atopic Dermatitis 5)Patients currently receiving interferon drug treatment (i.e., interferon -a, interferon -ß, etc.) 6)Patients with liver diseases (i.e., liver cirrhosis or liver cancer) 7)Patients with platelet count =100,000/mm3 due to chronic hepatitis-induced liver dysfunction 8)Patients with kidney diseases (i.e., acute/chronic renal failure, renal syndrome, etc.) 9)Patients with acute severe cardiovascular diseases (i.e., cardiac failure, myocardial infarction, cerebral infarction, etc.) 10)Patients with chronic diseases (i.e., uncontrolled hypertension or diabetes, etc.), gastrointestinal disorders, hyperhidrosis, dysuria, etc. 11)Patients receiving potassium-containing drug treatment, licorice-containing drug treatment, glycyrrhizinic acid or its salts-containing drug treatment, loop diuretics (furosemide, ethacrynic acid) or thiazides diuretics (trichloromethiazide) within 4 weeks prior to the start of the study 12)Patients receiving ephedra or ephedrine-containing drug treatment, Monoamine oxidase(MAO) inhibitors, thyroid drug treatment, catecholamine drug treatment, or xanthine drug treatment within 4 weeks prior to the start of the study 13)Patients with a history of antipsychotic drug use within 2 months prior to the screening examination 14)Patients who have participated in other clinical trials within the past 4 weeks 15)Patients with a history of hypersensitivity or allergic reaction to an ingredient of the clinical trial product or the product itself 16)Patients with a history of drug or alcohol abuse 17)Patients who are pregnant or breastfeeding 18)Patients who may become pregnant and have not used appropriate contraceptives (excluding those who have undergone sterilization surgery) 19)Screening examination revealed thyroid-stimulating hormone (TSH) in the normal range 0.1 uIU / ml or less, or 10.0 uIU / ml or higher in patients with thyroid dysfunction 20)Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including diagnostic radiology outcomes ? Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit ? Serum Creatinine > 2.0 mg/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scoring atopic dermatitis(SCORAD) total score and sub-scores | — |
Secondary
| Measure | Time frame |
|---|---|
| Amount and frequency of ointment usage for Atopic dermatitis;Dermatology life quality index score;Itchiness and sleep disability score in visual analogue scale score;Skin moisture content;Skin surface temperature (Digital Infrared Thermography Imaging);Hamilton Anxiety Rating Scale score;Beck depression inventory-Korean version score;Stress/Autonomic nervous system test;Questionnaire survey score of Attention deficit hyperactive disorder (ADHD) | — |
Countries
Korea, Republic of
Contacts
Public ContactYu-Hwa Shim
Wonkwang University. Iksan Korean Medicine Hospital
Outcome results
None listed