NCT01270048已完成3 期
The Effect of Bunsimgi-eum(Fenxinqiyin) on the Chest Discomfort of Hwa-byung's Major Symptom : Randomized, Double-blinded, Placebo-control 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
- 144
- 试验地点
- 1
研究概览
简要总结
The purpose of this research is to examine the effect of Bunsimgi-eum on the chest discomfort of Hwa-byung's major symptom and develope and establish pattern identification system in 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
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
Bunsimgieum extract
Experimental
- name of product: 'mild-x-gwarip'
- standard code for item: 200005689
- 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: mild-ex-gwarip (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)
研究者
研究点 (1)
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