None listed
Conditions
Interventions
Drug : 1. Investigational Product
- Product name: Eokgansan-Gajinpibanha Extract Granules
- Dosage form and appearance: Light brown granules
- Composition and amount per single dose (3 g):
Active ingr
Sponsors
Kyung Hee University Industry-University Cooperation Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria to be eligible for the study: 1) Male or female adults aged 19 to 65 years. 2) Individuals who meet the diagnostic criteria for Hwa-byung (U22.2) as assessed by the Structured Clinical Interview for Hwa-byung (SCID). 3) Individuals who meet the diagnostic criteria for nervousness (R45.0, nervousness), based on age- and sex-adjusted cutoff scores for the “Gyeong” and “No” subscales of the short-form Core Emotional Assessment Questionnaire. 4) Individuals who have received and understood a full explanation of the study, have voluntarily decided to participate, and have provided written informed consent, agreeing to comply with all study-related precautions and procedures.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study: 1) Individuals assessed to be at risk of suicide. 2) Individuals currently diagnosed with or receiving treatment for schizophrenia, antisocial personality disorder, borderline personality disorder, histrionic personality disorder, or other severe personality disorders (including paranoid, schizoid, narcissistic, avoidant, or dependent personality disorders). 3) Individuals with a history of manic episodes, hypomanic episodes, or mixed episodes. 4) Individuals with current or past alcohol or other substance abuse or dependence. 5) Individuals with medical conditions that may influence the severity or manifestation of Hwa-byung symptoms (e.g., hyperthyroidism). 6) Individuals with chronic diseases that are poorly controlled despite appropriate treatment (e.g., chronic active hepatitis, hypertension, diabetes mellitus). *Poorly controlled hypertension is defined as blood pressure remaining above 140/90 mmHg despite treatment with an appropriate combination of three or more antihypertensive agents, including a diuretic, at adequate doses. *Poorly controlled diabetes mellitus is defined as persistent HbA1c = 9.0% despite treatment with an appropriate combination of antidiabetic medications at adequate doses. 7) Individuals with hepatic or renal impairment, defined at screening as ALT, AST, or ALP = 2 times the upper limit of normal, or BUN or creatinine > 1.2 times the upper limit of normal. 8) Individuals with hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose–galactose malabsorption. 9) Individuals with diseases affecting drug absorption or with gastrointestinal dysfunction following surgery that may impair drug absorption. 10) Individuals who have participated in another clinical trial within one month prior to study initiation. 11) Individuals with a history of hypersensitivity or allergic reactions to the investigational product or related medications. 12) Individuals currently taking herbal medicines or crude herbal preparations other than the investigational product. 13) Individuals with intellectual disability or cognitive impairment that may preclude understanding informed consent or compliance with study procedures. 14) Pregnant or breastfeeding women. 15) Women of childbearing potential who do not agree to use approved contraceptive methods during the study period (double-barrier contraception*, intrauterine devices, or spermicides). *Double-barrier contraception refers to the use of a barrier method (e.g., condoms, diaphragm) in combination with another contraceptive method such as sterilization, intrauterine devices, or contraceptive creams, gels, or foams. 16) Individuals deemed by the investigator to be unsuitable for participation in the study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hwabyung Comprehensive Test (HCT) | — |
Secondary
| Measure | Time frame |
|---|---|
| State–Trait Anger Expression Inventory-Korean Version (STAXI-K);Beck Depression Inventory–Korean version (K-BDI);Beck Anxiety Inventory (BAI);Difficulties in Emotion Regulation Scale–Korean version (K-DERS);Heart rate variability test (HRV test) | — |
Countries
Korea, Republic of
Contacts
Public ContactHui-Yeong Park
Kyung Hee University
Outcome results
None listed