None listed
Conditions
Interventions
Drug : - Intervention group (Herbal medicine Bojungikgi-tang group): brown powder, one pack (2.06 g) per dose, three times daily, administered for 8 weeks
- Control group (Herbal medicine Sihocheongga
Sponsors
Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female participants aged 12 to 65 years at the time of screening. 2) Participants reporting fatigue with a Visual Analog Scale (VAS) score = 40 mm. 3) Participants diagnosed with atopic dermatitis according to the Hanifin and Rajka diagnostic criteria. 4) Participants with a SCORing Atopic Dermatitis (SCORAD) score indicating mild (<25) or moderate (25 = SCORAD < 50) atopic dermatitis at screening. 5) Participants with a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 2 (mild) or 3 (moderate) at screening. 6) Participants with a stable disease status, defined as having experienced no improvement or worsening of atopic dermatitis and fatigue symptoms for at least 1 month prior to screening. 7) Participants who have received a full explanation of the clinical trial, have understood the study procedures and requirements, have voluntarily agreed to participate, and have provided written informed consent to comply with all study-related instructions and precautions.
Exclusion criteria
Exclusion criteria: 1) Participants with severe dermatological diseases other than atopic dermatitis (e.g., severe psoriasis, systemic lupus erythematosus, bullous disorders such as pemphigus or bullous pemphigoid, ichthyosis, cutaneous T-cell lymphoma, etc.). 2) Participants who, within 4 weeks prior to screening, received oral corticosteroids, oral or injectable antibiotics, systemic immunosuppressants, psychotropic medications, or systemic photochemotherapy; who, within 1 week prior to screening, used antihistamines, topical corticosteroids, topical immunomodulators, or topical antibiotics; or who, within 2 weeks prior to screening, received Korean medicine treatment or consumed health functional foods intended to improve fatigue or atopic dermatitis. However, participants who received Korean medicine treatment or health functional foods for reasons unrelated to fatigue or atopic dermatitis (e.g., common cold, dyspepsia, or other general illnesses) will not be excluded. 3) Participants with hepatic or renal dysfunction, defined as ALT, AST, or serum creatinine levels = 2 times the upper limit of normal (ULN) at screening. 4) Participants with hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 5) Participants with myopathy associated with pseudoaldosteronism or hypokalemia. 6) Participants with a past or current history of underlying conditions that may cause fatigue, including but not limited to cancer, sleep disorders, active hepatitis A, chronic hepatitis, liver cirrhosis, chronic renal failure, active tuberculosis, latent tuberculosis, hypothyroidism, or multiple sclerosis. 7) Participants with uncontrolled hypertension, defined as blood pressure = 180/110 mmHg. 8) Participants with uncontrolled diabetes mellitus, defined as HbA1c = 7.0% or random blood glucose = 200 mg/dL at screening. 9) Participants with a known history of hypersensitivity to any component of the investigational products. 10) Participants currently receiving treatment for psychotic disorders (e.g., schizophrenia, delusional disorder), bipolar disorder, or major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), or those with a past or current history of alcohol use disorder or substance use disorder. 11) Participants with a smoking history of more than 30 pack-years. 12) Pregnant or breastfeeding women. 13) Participants who are unwilling to use a medically acceptable method of contraception from the time of informed consent until completion of study participation. Medically acceptable contraceptive methods include: - Use of an intrauterine device (IUD) with a documented low failure rate by the participant’s partner; - Concurrent use of a barrier method (male or female) and a spermicide; - Surgical sterilization of the participant or partner (e.g., vasectomy, tubal ligation/salpingectomy, or hysterectomy). 14) Participants who have participated in another clinical trial involving an investigational medicinal product within 4 weeks prior to enrollment (based on the date of written informed consent). 15) Participants deemed unsuitable for participation in the study for any other reason at the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SCORing of Atopic Dermatitis (SCORAD) total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue Severity Scale;SCORing of Atopic Dermatitis (SCORAD) total score;SCORing of Atopic Dermatitis (SCORAD) - objective score, subjective score ;Eczema Area and Severity Index;Validated Investigator Global Assessment scale for Atopic Dermatitis;Dermatology Life Quality Index/Children's Dermatology Life Quality Index;Visual Analogue Scale for Fatigue;Visual Analog Scale for Digestive Symptoms;Patient Health Questionnaire-9/Patient Health Questionnaire-9 Modified for Adolescents;Total IgE, Eosinophil count;EuroQol-5 Dimentions-5 Levels;Frequency and amount of use of remedies;Overall assessment of atopic dermatitis;Adverse events;Hematology and blood chemistry tests;vital sign | — |
Countries
Korea, Republic of
Contacts
Public ContactKyuseok Kim
Kyung Hee University
Outcome results
None listed