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

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

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Drug: Placebo; Drug: KyungBangn-Gamisoyosan-x-gwarip; Drug: KyungBangn Gamisoyosan

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: standard code for item: 200005591

What is the study measuring?

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
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
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
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

Collaborators and Investigators

• Sponsor: Korea Health Industry Development Institute
• Investigators: Principal Investigator: In-Chul Jung, Ph.D, Oriental Hospital of Daejon University

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: January 26, 2011
• First Submitted That Met QC Criteria: January 26, 2011
• First Posted (Estimate): January 27, 2011

Study Record Updates

• Last Update Posted (Estimate): January 27, 2011
• Last Update Submitted That Met QC Criteria: January 26, 2011
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: anxiety; Generalized anxiety disorder; Jingji-zhengchong; Gamisoyosan
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders
• Other Study ID Numbers: B082005