The Comparative Clinical Study of Gamisoyosan on Anxiety of Generalized Anxiety Disorder According to Dosage Form

• 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.
• Symptom Checklist-90-Revised(SCL-90R) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  The Symptom Checklist-90-R (SCL-90-R) is a relatively brief self-report psychometric instrument (questionnaire). It is designed to evaluate a broad range of psychological problems and symptoms of psychopathology. It is also used in measuring the progress and outcome of psychiatric and psychological treatments or for research purposes.
• 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.
• PSWQ [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  The Penn State Worry Questionaire is a 16-item inventory assess worry and anxiety
• GSES [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life.
• RSE [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  Rosenberg Self-Esteem Scale is questionnaire that popular lore recognizes just "high" self-esteem and "low" self-esteem, the Rosenberg Self-Esteem Scale quantify it in more detail, and feature among the most widely used systems for measuring self-esteem.

In this randomized, double blinded, Parallel-controlled study, the investigators planned to give Gamisoyosan extract, Gamisoyosan extract powder or controlled medication on Anxiety of generalized anxiety disorder according to dosage form.

• Drug: Placebo
  AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
• Drug: KyungBangn-Gamisoyosan-x-gwarip
  AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
  Other Name: standard code for item : 200005799
• Drug: KyungBangn Gamisoyosan
  AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
  Other Name: standard code for item: 200005591

• 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, content: adults;three times a day each sack taken before or between meals
  • dose, standard: for each sack 7.67g
  • storage : airtight container, stored in room temperature
  • expiration date : after manufacture 36 month
  • macufacturing company: KyungBangnShinYak inc.
  Intervention: Drug: Placebo
• Active Comparator: Gamisoyosan extract
  • name of product: KyungBangn-Gamisoyosan-x-gwarip
  • standard code for item : 200005799
  • shape, type: extract(grayish brown)
  • usage, content : adults;three times a day , each sack taken before or between meals
  • dose, standard: 7.67g for each sack
  • storage : airtight container, stored in room temperature expiration date : after manufacture 36 month macufacturing company: KyungBangnShinYak inc.
  Intervention: Drug: KyungBangn-Gamisoyosan-x-gwarip
• Active Comparator: Gamisoyosan extract powder
  • name of product: KyungBangn Gamisoyosan
  • standard code for item: 200005591
  • shape, type: powder(brown)
  • usage, content: adults;three times a day each sack taken before or between meals
  • dose, standard: 7.67g for each sack
  • storage : airtight container, stored in room temperature
  • expiration date : after manufacture 36 month
  • macufacturing company: KyungBangnShinYak inc.
  Intervention: Drug: KyungBangn Gamisoyosan

Inclusion Criteria:

• Male or female aged 20-65
• (Structured Clinical Interview for DSM-Ⅳ Axis Ⅰ Disorder, SCID-Ⅰ) subjects who meet Structured Clinical Interview for DSM-Ⅳ Axis Ⅰ Disorder, SCID-Ⅰof generalized anxiety disorder

Exclusion Criteria:

• Currrent or past history of delusions, halucination
• 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. antianxiety drugs, antidepressant, antipsychotic drug, steroids, female hormonal drug, L-dopa, digitalis, bromide, cyclosporin, disulfiram, isoniazid, yohimbine) which might affect symptoms
• Medical conditions(e.g. myocardial infarction,brain tumor, multiple sclerosis, pancreatic disease, hyperthyroidism, hypothyroidism, Addison disease, Cushing disease, rheumarthritis, cancer, CVA, epilepsy, anemia, pituitarium disease, Vit B12 deficiency disease, PMS) 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