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

Generalized Anxiety Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01285115
• Other study ID #: B082005
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2011
• Last updated: January 26, 2011
• Start date: December 2008
• Est. completion date: July 2010

Study information

• Verified date: October 2010
• Source: Korea Health Industry Development Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female aged 20-65

• (Structured Clinical Interview for DSM-? Axis ? Disorder, SCID-?) subjects who meet Structured Clinical Interview for DSM-? Axis ? Disorder, SCID-?of 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• Placebo
AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
• 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.
• KyungBangn Gamisoyosan
AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Oriental Hospital of Daejon University	Daejon	Choong-Chung-Do

Sponsors (1)

Lead Sponsor	Collaborator
Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	WHO Quality of Life Abbreviated(WHOQOL-BREF)	Quality of life is used to evaluate the general well-being of individuals and societies.	8 weeks	No
Secondary	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	No
Secondary	PSWQ	The Penn State Worry Questionaire is a 16-item inventory assess worry and anxiety	8 weeks	No
Secondary	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	No
Secondary	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	No