None listed
Conditions
Interventions
Drug : Intervention: Gwakhyangjeonggi-san (GJS, Huoxiang-zhengqi-san in Chinese, Kakkoshoki-san in Japanese) administered orally as a single dose of 3 g thrice a day (total of 9 g per day) for 8 weeks
Sponsors
Kyung Hee University Oriental Medicine Hospital at Gangdong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women aged 19–60 years. 2. Diagnosis of atopic dermatitis based on the Hanifin and Rajka diagnostic criteria, which require that = 3 major features and = 3 minor features be fulfilled. 3. Diagnosis of gastroduodenal or bowel disorder based on the ROME IV Questionnaire. 4. Moderate atopic dermatitis diagnosed by the SCORing of Atopic Dermatitis score (score 25–50). 5. Ability to comprehend the purpose of the study, the study procedure, and the properties of the investigational drug, as well as voluntary agreement to participate in the study (provision of written informed consent).
Exclusion criteria
Exclusion criteria: 1. Diagnosis of concomitant skin disorders that make it difficult to accurately evaluate cutaneous symptoms of atopic dermatitis. 2. Use of orally administered corticosteroids or antibiotics, administration of psoralen and ultraviolet A therapy or immune-suppressants within the last 4 weeks preceding screening visit. 3. Use of medications including herbal preparations, dietary supplements, or probiotics for symptomatic improvement of atopic dermatitis within the last 4 weeks of screening. 4. Diagnosis of serious medical conditions that could interfere with clinical trial participation, including the following: 4-1. Uncontrolled hypertension (systolic blood pressure = 160 mmHg and diastolic blood pressure = 100 mmHg). 4-2. Uncontrolled diabetes mellitus (glycated hemoglobin = 6.5%). 4-3. Abnormal kidney function test results showing serum creatinine levels > 2-fold the upper limit of the reference range. 4-4. Abnormal liver function test results showing serum alanine aminotransferase or aspartate aminotransferase levels >2-fold the upper limit of the reference range. 4-5. Other serious inflammatory and systemic diseases. 4-6. Past or present history of malignant tumors. 5. Genetic disorders, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 6. Intake of other clinical trial drugs within a month preceding the start date of the investigational drugs for the present trial. 7. Pregnancy, planning a pregnancy, or breastfeeding. 8. Known history of hypersensitivity or allergic reaction to the investigational drug or its ingredients. 9. Communication difficulties that prevent adequate compliance with the investigator’s instructions. 10. Ineligibility for participation determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SCORing of Atopic Dermatitis (SCORAD index) | — |
Secondary
| Measure | Time frame |
|---|---|
| Eczema Area and Severity Index (EASI);Dermatology Life Quality Index (DLQI);EuroQol-5Dimentions-5Levels (EQ-5D-5L);Korean Gastrointestinal Symptom Rating Scale (KGSRS);Nepean Dyspepsia Index;total serum Immunoglobulin E;ImmunoCAP test;Eosinophil cationic protein (ECP) | — |
Countries
Korea, Republic of
Contacts
Public ContactMinseo Kang
Kyung Hee University Oriental Medicine Hospital at Gangdong
Outcome results
None listed