NCT01362114Unknown4 期
Phase 4 Study of The Effect of Sihogayonggolmoryeo-tang on the Anxiety of Hwa-byung : A Randomized, Double Blind, Placebo-control Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 160
- 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, Placebo-control Trial, the investigators planned to give Sihogayonggolmoryeo-tang extract or controlled medication on the Anxiety of Hwa-byung.
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
- 否
入选标准
- •male or female aged 20-65
- •subjects who meet structured interview criteria for Hwa-Byung Diagnosis
- •subjects who have axiety (more than 17 score in HAMA)
排除标准
- •duration of illness less than 6 months
- •current or past history of delusions, hallucination
- •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. steroids) which might affect symptoms
- •medical conditions(e.g. hyperthyroidism, hypothyroidism, heart disease) 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
Sihogayonggolmoryeo-tang extract
Experimental
- name of product: 'SIHOGAYONGGOLMORYU TANG EXTRACT GRAN'
- standard code for item: 200005676
- shape, type: extract(brown)
- usage, content: adults;three times a day, each taken before or between meals
- dose, standard: 2.5g for each sack, capsulated
- storage : airtight container, stored in room temperature
- expiration date : 36months after manufacture
- macufacturing company: KyungBangnShinYak inc.
干预措施: SIHOGAYONGGOLMORYU TANG EXTRACT GRAN (Drug)
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, dose: adults: three times a day, 1 sack before or between meals
- dose, standard: 2.5g for each sack, capsulated
- storage : airtight container, stored in room temperature
- expiration date : 36 months after manufacture
- manufacturing company: KyungBangnShinYak inc.
干预措施: Placebo (Other)
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)
- WHO Quality of Life Abbreviated(WHOQOL-BREF)(8 weeks)
- Heart Rate Variability(HRV)(8 weeks)
- likert scale(8 weeks)
- Hwa-byung scale(8 weeks)
- State-Trait Anger Expression Inventory (STAXI)(8 weeks)
- Insomnia Severity Index (ISI)(8 weeks)
- Instrument of Oriental Medical Evaluation for Hwa-Byung(8 weeks)
研究者
In-Chul Jung
Professor of Oriental Hospital of Daejon University
Korea Health Industry Development Institute
研究点 (1)
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