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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Generalized Anxiety Disorder	Drug: Placebo; Drug: KyungBangn-Gamisoyosan-x-gwarip; Drug: KyungBangn Gamisoyosan	Phase 3

Study Design

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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

Arms and Interventions

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Arm	Intervention/treatment
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.	Drug: Placebo; AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
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.	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
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.	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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. PSWQ [ Time Frame: 8 weeks ]
   The Penn State Worry Questionaire is a 16-item inventory assess worry and anxiety
7. 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.
8. 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Korea, Republic of
Oriental Hospital of Daejon University
Daejon, Choong-Chung-Do, Korea, Republic of

Sponsors and Collaborators

Korea Health Industry Development Institute

Investigators

Principal Investigator:	In-Chul Jung, Ph.D	Oriental Hospital of Daejon University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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