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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo
KyungBangn-Gamisoyosan-x-gwarip
KyungBangn Gamisoyosan
Sponsored by
Korea Health Industry Development Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized anxiety disorder, Jingji-zhengchong, Gamisoyosan, anxiety

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oriental Hospital of Daejon University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo; corn flour,

Gamisoyosan extract

Gamisoyosan extract powder

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
WHO Quality of Life Abbreviated(WHOQOL-BREF)
Quality of life is used to evaluate the general well-being of individuals and societies.
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.
PSWQ
The Penn State Worry Questionaire is a 16-item inventory assess worry and anxiety
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.
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.

Full Information

First Posted
January 26, 2011
Last Updated
January 26, 2011
Sponsor
Korea Health Industry Development Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01285115
Brief Title
The Comparative Clinical Study of Gamisoyosan on Anxiety of Generalized Anxiety Disorder According to Dosage Form
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 Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Korea Health Industry Development Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Generalized anxiety disorder, Jingji-zhengchong, Gamisoyosan, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo; corn flour,
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Gamisoyosan extract
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Gamisoyosan extract powder
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Placebo
Intervention Description
AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
Intervention Type
Drug
Intervention Name(s)
KyungBangn-Gamisoyosan-x-gwarip
Other Intervention Name(s)
standard code for item : 200005799
Intervention Description
AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
Intervention Type
Drug
Intervention Name(s)
KyungBangn Gamisoyosan
Other Intervention Name(s)
standard code for item: 200005591
Intervention Description
AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
Primary Outcome Measure Information:
Title
Hamilton Anxiety Scale(HAM-A)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory(STAI)
Description
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.
Time Frame
8 weeks
Title
Beck Depression Inventory(BDI)
Description
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.
Time Frame
8 weeks
Title
Symptom Checklist-90-Revised(SCL-90R)
Description
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.
Time Frame
8 weeks
Title
WHO Quality of Life Abbreviated(WHOQOL-BREF)
Description
Quality of life is used to evaluate the general well-being of individuals and societies.
Time Frame
8 weeks
Title
Heart Rate Variability(HRV)
Description
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.
Time Frame
8 weeks
Title
PSWQ
Description
The Penn State Worry Questionaire is a 16-item inventory assess worry and anxiety
Time Frame
8 weeks
Title
GSES
Description
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.
Time Frame
8 weeks
Title
RSE
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Chul Jung, Ph.D
Organizational Affiliation
Oriental Hospital of Daejon University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oriental Hospital of Daejon University
City
Daejon
State/Province
Choong-Chung-Do
Country
Korea, Republic of

12. IPD Sharing Statement

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

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