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

Study Overview
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Brief Summary
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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.

Official Title
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Phase 3 The Comparative Clinical Study of Gamisoyosan on Anxiety of Generalized Anxiety Disorder According to Dosage Form : A Randomized, Double Blind, Parallel-controlled Trial

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Drug: Placebo
* Drug: KyungBangn-Gamisoyosan-x-gwarip
* Drug: KyungBangn Gamisoyosan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo; corn flour,<br>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. | Drug: Placebo<br>* AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.<br>|
| Active Comparator: Gamisoyosan extract<br>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. | Drug: KyungBangn-Gamisoyosan-x-gwarip<br>* AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.<br>* Other names: standard code for item : 200005799;|
| Active Comparator: Gamisoyosan extract powder<br>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. | Drug: KyungBangn Gamisoyosan<br>* AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.<br>* Other names: standard code for item: 200005591;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Anxiety Scale(HAM-A) | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anxiety Inventory(STAI) | 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. | 8 weeks | 
| Beck Depression Inventory(BDI) | 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. | 8 weeks | 
| Symptom Checklist-90-Revised(SCL-90R) | 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. | 8 weeks | 
| WHO Quality of Life Abbreviated(WHOQOL-BREF) | Quality of life is used to evaluate the general well-being of individuals and societies. | 8 weeks | 
| Heart Rate Variability(HRV) | 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. | 8 weeks | 
| PSWQ | The Penn State Worry Questionaire is a 16-item inventory assess worry and anxiety | 8 weeks | 
| GSES | 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. | 8 weeks | 
| RSE | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized anxiety disorder, Jingji-zhengchong, Gamisoyosan, anxiety