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Completed

NCT Number: NCT01285115

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

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Oriental Hospital of Daejon University

Daejeon, Choong-Chung-Do, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

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

Drug

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

KyungBangn Gamisoyosan

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Korea Health Industry Development Institute

Other Gov

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 27, 2011
Registry last updated
Jan 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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