The Comparative Clinical Study of Gamisoyosan on Anxiety of Generalized Anxiety Disorder According to Dosage Form
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ClinicalTrials.gov Identifier: NCT01285115 |
Recruitment Status
:
Completed
First Posted
: January 27, 2011
Last Update Posted
: January 27, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Generalized Anxiety Disorder | Drug: Placebo Drug: KyungBangn-Gamisoyosan-x-gwarip Drug: KyungBangn Gamisoyosan | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 147 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | July 2010 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo; corn flour,
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Drug: Placebo
AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
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Active Comparator: Gamisoyosan extract
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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
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Active Comparator: Gamisoyosan extract powder
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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
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- Hamilton Anxiety Scale(HAM-A) [ Time Frame: 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.
- State-Trait Anxiety Inventory(STAI) [ Time Frame: 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.
- Beck Depression Inventory(BDI) [ Time Frame: 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.
- Symptom Checklist-90-Revised(SCL-90R) [ Time Frame: 8 weeks ]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 ]Quality of life is used to evaluate the general well-being of individuals and societies.
- Heart Rate Variability(HRV) [ Time Frame: 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.
- PSWQ [ Time Frame: 8 weeks ]The Penn State Worry Questionaire is a 16-item inventory assess worry and anxiety
- GSES [ Time Frame: 8 weeks ]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 ]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.

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Ages Eligible for Study: | 20 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285115
Korea, Republic of | |
Oriental Hospital of Daejon University | |
Daejon, Choong-Chung-Do, Korea, Republic of |
Principal Investigator: | In-Chul Jung, Ph.D | Oriental Hospital of Daejon University |
Responsible Party: | the president of Korea Health Industry Development Institute, Korea Health Industry Development Institute |
ClinicalTrials.gov Identifier: | NCT01285115 History of Changes |
Other Study ID Numbers: |
B082005 |
First Posted: | January 27, 2011 Key Record Dates |
Last Update Posted: | January 27, 2011 |
Last Verified: | October 2010 |
Keywords provided by Korea Health Industry Development Institute:
Generalized anxiety disorder Jingji-zhengchong Gamisoyosan anxiety |
Additional relevant MeSH terms:
Disease Anxiety Disorders Pathologic Processes Mental Disorders |