NCT01285115已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Hamilton Anxiety Scale(HAM-A)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo; corn flour,
Placebo Comparator
- 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.
干预措施: Placebo (Drug)
Gamisoyosan extract
Active Comparator
- 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.
干预措施: KyungBangn-Gamisoyosan-x-gwarip (Drug)
Gamisoyosan extract powder
Active Comparator
- 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.
干预措施: KyungBangn Gamisoyosan (Drug)
结局指标
主要结局
Hamilton Anxiety Scale(HAM-A)
时间窗: 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.
次要结局
- State-Trait Anxiety Inventory(STAI)(8 weeks)
- Beck Depression Inventory(BDI)(8 weeks)
- Symptom Checklist-90-Revised(SCL-90R)(8 weeks)
- WHO Quality of Life Abbreviated(WHOQOL-BREF)(8 weeks)
- Heart Rate Variability(HRV)(8 weeks)
- PSWQ(8 weeks)
- GSES(8 weeks)
- RSE(8 weeks)
研究者
研究点 (1)
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