None listed
Conditions
Interventions
Drug : Experimental: Sopoongsan (5.0g/time), 3 times a day, for 4 weeks, before each meal or between meals
Placebo Comparator: Placebo (5.0g/time), 3 times a day, for 4 weeks, before each meal or betw
Sponsors
Kyung Hee University Oriental Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult patients aged =19 years 2) NRS score for upper body pruritus of =3 3) Pruritus of =3 months 4) Diagnosis: allergic atopic and seborrheic dermatitis 5) Provided voluntary written informed consent to participate in this clinical study
Exclusion criteria
Exclusion criteria: 1) NRS score for upper body pruritus of =7 2) History of taking oral adrenal corticosteroids (steroids) or immunosuppressants for skin itching within the last 4 weeks 3) Skin diseases caused by bacterial or viral infections 4) Clinical abnormality of liver and renal function tests (i.e., ALT, AST, ALP) =2 times the upper limit of normal or creatinine >2.0 mg/dL at screening 5) Severe acute cardiovascular disease (i.e., heart failure, myocardial infarction, stroke, hypertension, or diabetes) 6) Serious conditions of hyperlipidemia, anemia, active pulmonary tuberculosis, thyroid disease, and other infectious and systemic diseases 7) Past or present malignant tumors 8) Antipsychotic drug treatment within 2 months before screening test 9) History of acute or chronic pancreatitis or gastrointestinal surgery (except for simple appendix surgery or hernia surgery) 10) Genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 11) History of hypersensitivity reactions to the constituents of the clinical trial treatments 12) History of drug or alcohol abuse 13) Pregnant and lactating women or in case or accepting the implementation of an appropriate contraceptive method among women of pregnant potential who are likely to become pregnant (except for women who have undergone sterilization) 14) Plan to participate in other clinical trials after enrollment in this clinical trial, or who have participated in other clinical trials during the 30 days prior to registration in this clinical trial 15) Inappropriate patients as considered by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numeric Rating Scale (NRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatological Life Quality Index (DLQI);Epworth Sleepiness Scale;The serum interferon-gamma (INF-?), interleukin (IL)-4, immunoglobulin E (IgE), thymic stromal lymphopoietin (TSLP), Histamine, Inflammation array | — |
Countries
Korea, Republic of
Contacts
Public ContactPurumea Jun
Korea Institute of Oriental Medicine
Outcome results
None listed