The Comparative Clinical Study of Gamisoyosan on Anxiety of Generalized Anxiety Disorder According to Dosage Form
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Registration Number
- NCT01285115
- Lead Sponsor
- Korea Health Industry Development Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 147
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo; corn flour, Placebo * 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. Gamisoyosan extract KyungBangn-Gamisoyosan-x-gwarip * 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. Gamisoyosan extract powder KyungBangn Gamisoyosan * 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.
- Primary Outcome Measures
Name Time Method Hamilton Anxiety Scale(HAM-A) 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 Outcome Measures
Name Time Method State-Trait Anxiety Inventory(STAI) 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.
Beck Depression Inventory(BDI) 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.
Symptom Checklist-90-Revised(SCL-90R) 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.
WHO Quality of Life Abbreviated(WHOQOL-BREF) 8 weeks Quality of life is used to evaluate the general well-being of individuals and societies.
Heart Rate Variability(HRV) 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.
PSWQ 8 weeks The Penn State Worry Questionaire is a 16-item inventory assess worry and anxiety
GSES 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.
RSE 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.
Trial Locations
- Locations (1)
Oriental Hospital of Daejon University
🇰🇷Daejon, Choong-Chung-Do, Korea, Republic of