Effects of Bojungikgi-tang on anorexic patients with atopic dermatitis: a protocol for a randomized, usual care-controlled, assessor-blinded, parallel, pilot clinical trial
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0006784
- Lead Sponsor
- Daejeon Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
(1) adults aged 19-65 years at the screening visit
(2) the intensity of anorexia measured by 0-100mm visual analogue scale is 40 points or more
(3) diagnosis of atopic dermatitis based on the Hanifin and Rajka diagnostic criteria
(4) mild to moderate atopic dermatitis diagnosed by the SCORing of Atopic Dermatitis score (score 15–50).
(5) those who have voluntarily signed written informed consent approved by the institutional review board, after sufficient explanation of this study
(1) those who have an organic disease that can cause anorexia or have alarm symptoms such as rapid weight loss of 10% or more within the last 6 months
(2) those who have received an appetite stimulant, health functional food (other than lactic acid bacteria) and Korean medicine treatment for the purpose of improving anorexia within 2 weeks prior to screening
(3) those with severe skin diseases other than atopic dermatitis
(4) those who have received oral steroids, oral antibiotics, systemic immunosuppressants, or systemic photochemotherapy within 4 weeks prior to screening, those who have used antihistamines, topical steroids, topical immunomodulators and topical antibiotics within 1 week prior to screening, and those who received health functional food (excluding lactic acid bacteria) and Korean medicine treatment for the purpose of improving atopic dermatitis within 2 weeks prior to screening
(5) those who started administering lactic acid bacteria within 2 weeks prior to screening
(6) participants with serious medical conditions to participate in this clinical trial
6-1. those who have been diagnosed with a mental illness such as anorexia nervosa, depression, or anxiety disorder
6-2. uncontrolled hypertension (in case of systolic blood pressure of 180 mmHg or higher or diastolic blood pressure of 110 mmHg or higher at screening)
6-3. uncontrolled diabetes (in case of HbA1c of 9% or higher or fasting blood glucose of 160 mg/dl or higher at screening)
6-4. severe liver or renal disease (aspartate aminotransferase or alanine aminotransferase levels = 3 times upper limit of normal or creatinine levels = 2 times upper limit of normal)
6-5. past or present malignancy
6-6. serious uncontrolled systemic diseases including cardiovascular, respiratory, digestive, genitourinary, nervous/psychiatric and blood diseases, or serious infectious diseases
(7) participants with a history of alcohol abuse or drug abuse within the past year
(8) participants with genetic problems, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
(9) participants with known hypersensitivity to investigational products
(10) participants who had taken other investigational products within 4 weeks
(11) women who are pregnant or lactating, or women who do not agree to use effective methods of contraception during the clinical trial
(12) participants who are judged to be inappropriate for participating this study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anorexia visual analogue scale
- Secondary Outcome Measures
Name Time Method Anorexia visual analogue scale;Body weight, body fat percentage, body fat mass, skeletal muscle mass;SCORing of Atopic Dermatitis (SCORAD) total score, objective score, subjective score ;Validated Investigator Global Assessment scale for Atopic Dermatitis;Dermatology Life Quality Index (DLQI);EuroQol-5 Dimentions-5 Levels (EQ-5D-5L);Deficiency-excess pattern identification score;Total IgE, Eosinophil count;liver and renal function test (AST, ALT, BUN, Creatinine);adverse reaction;Intestinal microbial composition;Blood immunity and metabolic indicators;Frequency and amount of use of remedies (Lidomex Cream 0.15%)