Efficacy and Safety of Bunsimgieum-gami on Hwa-byung
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0003263
- Lead Sponsor
- Kyung Hee University Oriental Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
1) aged between 19 and 65
2) diagnosis of Hwa-byung by Hwa-byung Diagnostic Interview Schedule
3) willingness to participate and to sign the informed consent form.
1) high risk of suicide
2) current or lifetime severe psychiatric disorders (severe psychiatric disorders mean disorders that produce psychotic symptoms, such as schizophrenia)
3) current of previous intake of antidepressant, anxiolytic, or non-psychopharmacologocal drugs having psychotropic adverse effect within 4 weeks.
4) current or lifetime alcohol or drugs use disorders
5) serious unstable medical condition
6) hyperthyroidism or hypothyroidism
7) alanine aminotransferase and aspartate aminotransferase levels 1.5 times as high as or higher than the normal upper limit
8) blood urea nitrogen and creatinine levels 1.5 times as high as or higher than the normal upper limit
9) uncontrolled diabetes or hypertension
10) pregnancy or likelihood of pregnancy due to lack of proper contraception, or lactation.
11) current of previous intake of other drugs expect hypotensive, hypoglycemic, and antihyperlipidemic agents
12) participated in other clinical trials within 30 days
13) hypersesnsitivity to experimental or placebo medication of this clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ikert Scale for Hwa-byung Symptoms (HB-M)
- Secondary Outcome Measures
Name Time Method Patient Health Questionnaire Physical Symptoms (PHQ-15);Insomnia Severity Index (ISI);Stress Response Inventory (SRI);State-Trait Anger Expression Inventory-State Anger (STAXI-S);Adverse events