Hwa-byung
Conditions
Keywords
Hwa-byung, Sihogayonggolmoryeo-tang, Anxiety
Brief summary
In this randomized, double blinded, Placebo-control Trial, the investigators planned to give Sihogayonggolmoryeo-tang extract or controlled medication on the Anxiety of Hwa-byung.
Interventions
DRUGSIHOGAYONGGOLMORYU TANG EXTRACT GRAN
three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks
OTHERPlacebo
three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.
Sponsors
Korea Health Industry Development Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* male or female aged 20-65 * subjects who meet structured interview criteria for Hwa-Byung Diagnosis * subjects who have axiety (more than 17 score in HAMA)
Exclusion criteria
* duration of illness less than 6 months * current or past history of delusions, hallucination * past history of at least one manic episode, hypomanic episode, or mixed episode * current or past history of alcohol abuse or alcohol dependence history * taking substances(e.g. steroids) which might affect symptoms * medical conditions(e.g. hyperthyroidism, hypothyroidism, heart disease) that might affect symptoms * current with hepatoma, hepatic cirrhosis, chronic renal failure, congestive heart failure * pregnancy, lactation, women not using medically accepted means of birth control * considered not apt to carry out clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Anxiety Scale(HAM-A) | 8 weeks | The HAM-A (Hamilton Anxiety Scale) is a widely used interview scale that measures the severity of a patient's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory(BDI) | 8 weeks | BDI is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. |
| WHO Quality of Life Abbreviated(WHOQOL-BREF) | 8 weeks | Quality of life is used to evaluate the general well-being of individuals and societies. |
| Heart Rate Variability(HRV) | 8 weeks | Heart rate variability (HRV) is a physiological phenomenon where the time interval between heart beats varies. It is measured by the variation in the beat-to-beat interval. |
| likert scale | 8 weeks | This scale is used to evaluate the degree of Hwa-byung's major symptom by 5 point measure. (0,1,2,3,4) |
| State-Trait Anxiety Inventory(STAI) | 8 weeks | The State-Trait Anxiety Inventory (STAI) was initially conceptualized as a research instrument for the study of anxiety in adults. It is a self-report assessment device which includes separate measures of state and trait anxiety. |
| State-Trait Anger Expression Inventory (STAXI) | 8 weeks | The State-Trait Anger Expression Inventory is a inventory which measures the intensity of anger as an emotional state (State Anger) and the disposition to experience angry feelings as a personality trait (Trait Anger). Items consist of 4-point scales that assess intensity of anger at a particular moment and the frequency of anger experience, expression, and control. |
| Insomnia Severity Index (ISI) | 8 weeks | The Insomnia Severity Index is a series of questions, seven in total, designed by medical professionals to help gauge the seriousness of a person's insomnia. The seven questions have numerical value, and the total is added up at the end of the process to give a total that symbolizes the seriousness of the problem |
| Instrument of Oriental Medical Evaluation for Hwa-Byung | 8 weeks | Instrument of Oriental Medical Evaluation for Hwa-Byung is a standard scale to evaluate for Oriental Medical cure in Hwa-Byung |
| Hwa-byung scale | 8 weeks | This scale is used for self report to evaluate the Hwa-byung's emotional symptoms, physical symptoms and personality traits by 5 point.(0,1,2,3,4). |
Countries
South Korea
Contacts
Primary ContactBOK NAM SEO
Outcome results
None listed