The Comparative Clinical Study of Gamisoyosan on Anxiety of Generalized Anxiety Disorder According to Dosage Form - Full Text View

Purpose

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	Intervention	Phase
Generalized Anxiety Disorder	Drug: Placebo Drug: KyungBangn-Gamisoyosan-x-gwarip Drug: KyungBangn Gamisoyosan	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by Korea Health Industry Development Institute:

Primary Outcome Measures:

Hamilton Anxiety Scale(HAM-A) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Quality of life is used to evaluate the general well-being of individuals and societies.
Heart Rate Variability(HRV) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
The Penn State Worry Questionaire is a 16-item inventory assess worry and anxiety
GSES [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.


Enrollment:	147
Study Start Date:	December 2008
Study Completion Date:	July 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	20 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285115

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


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
Study First Received:	January 26, 2011
Last Updated:	January 26, 2011
Health Authority:	Korea: Ministry for Health and Welfare

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

ClinicalTrials.gov processed this record on September 23, 2016