The Effect of Sihogayonggolmoryeo-tang on the Anxiety of Hwa-byung

• State-Trait Anxiety Inventory(STAI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  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.
• Beck Depression Inventory(BDI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  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) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  Quality of life is used to evaluate the general well-being of individuals and societies.
• Heart Rate Variability(HRV) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  This scale is used to evaluate the degree of Hwa-byung's major symptom by 5 point measure. (0,1,2,3,4)
• Hwa-byung scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  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).
• State-Trait Anger Expression Inventory (STAXI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  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) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  Instrument of Oriental Medical Evaluation for Hwa-Byung is a standard scale to evaluate for Oriental Medical cure in Hwa-Byung

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.

• Drug: SIHOGAYONGGOLMORYU TANG EXTRACT GRAN
  three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks
  Other Name: standard code for item: 200005676
• Other: Placebo
  three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.

• Experimental: Sihogayonggolmoryeo-tang extract
  • name of product: 'SIHOGAYONGGOLMORYU TANG EXTRACT GRAN'
  • standard code for item: 200005676
  • shape, type: extract(brown)
  • usage, content: adults;three times a day, each taken before or between meals
  • dose, standard: 2.5g for each sack, capsulated
  • storage : airtight container, stored in room temperature
  • expiration date : 36months after manufacture
  • macufacturing company: KyungBangnShinYak inc.
  Intervention: Drug: SIHOGAYONGGOLMORYU TANG EXTRACT GRAN
• Placebo Comparator: Placebo; corn flour,
  • raw material: total contents(500㎎); cornstarch 50.0%(250.0㎎), 당수화물 49.45%(247.25㎎), caramel pigment 0.5%(2.5㎎), SsangHwa fragrance 0.05%(0.25㎎)
  • shape, type: extract(brown)
  • usage, dose: adults: three times a day, 1 sack before or between meals
  • dose, standard: 2.5g for each sack, capsulated
  • storage : airtight container, stored in room temperature
  • expiration date : 36 months after manufacture
  • manufacturing company: KyungBangnShinYak inc.
  Intervention: Other: Placebo

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