NCT00987805已完成4 期
Efficacy of Banhasasim-tang on Functional Dyspepsia : a Randomized, Double Blind, Placebo Controlled, Two-center Trial
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- Gastrointestinal Symptom (GIS) score (epigastric pain/upper abdominal pain, abdominal cramps, fullness, early satiety, loss of appetite, sickness, nausea, vomiting, retrosternal discomfort, and acidic regurgitation/heartburn)
研究概览
简要总结
The purpose of this study is to assess efficacy based on Gastrointestinal Symptom score and safety based on the rate of adverse event or laboratory findings of Banhasasim-tang administrated three times a day orally on functional dyspepsia.
详细描述
Banhasasim-tang
- Main 3 gram herb powder (including Rhizoma Pinelliae, Radix Scutellariae, Zingiberis Rhizoma, Panax ginseng, Glycyrrhiza uralensis Fisch, Zizyphi Fructus and Coptidis Rhizoma) of old oriental prescriptions for dyspepsia.
- Usually having used for dyspepsia in asia
- Need for correct clinical information by RCT
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Typical functional dyspepsia according to ROME III criteria.
- •One or more of:
- •Bothersome post-prandial fullness
- •Early satiation
- •Epigastric pain
- •Epigastric burning
- •No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms
- •The presence of 'moderate' as the degree of severity for at least three Gastrointestinal Symptom (GIS) score symptoms
- •Before participation of trial, epigastric pain or discomfort has persisted in a permanent or recurrent form for a minimum period of 12 weeks
- •Written and informed consent
排除标准
- •History of peptic ulcer or gastroesophageal reflux disease(GERD)
- •Current prominent symptoms of irritable bowel syndrome or GERD
- •Presence of the following alarm symptoms:
- •Severe weight loss
- •Black or tar stool
- •Dysphagia
- •Presence of the following diseases (like cholangitis, pancreatitis, etc.) or uncontrolled severe organ disorders
- •Women in pregnancy and lactation
- •History of gastrointestinal surgery or taking any drugs that may significantly alter digestive system
- •Participation of other clinical trials within the last 3 months
- •Severe mental problems or drug abuse
- •Judged by expert that they are appropriate to participate in this study
研究组 & 干预措施
Banhasasim-tang
Experimental
干预措施: Banhasasim-tang (Dietary Supplement)
Placebo drug
Placebo Comparator
The placebo of this study is corn-starch granules. It has the same form, color, flavor and amount like experimental herbal extracted formula
干预措施: Corn-starch granules (Dietary Supplement)
结局指标
主要结局
Gastrointestinal Symptom (GIS) score (epigastric pain/upper abdominal pain, abdominal cramps, fullness, early satiety, loss of appetite, sickness, nausea, vomiting, retrosternal discomfort, and acidic regurgitation/heartburn)
时间窗: Baseline, 2 weeks, 4 weeks, 6 weeks after administration, 4 and 8 weeks after treatment finish
次要结局
- Visual Analogue Scale (VAS) for overall discomfort due to dyspepsia(Baseline, 2weeks, 4weeks, 6weeks after administration, 4 and 8 weeks after treatment finish)
- Functional Dyspepsia-related Quality of Life (FD-QoL)(Baseline, 2 weeks, 4 weeks, and 6 weeks after administration, 4 and 8 weeks after treatment finish)
- Electrogastrography (EGG)(Baseline, 6 weeks after administration)
研究者
Jin-sung Kim
Full professor
Korea Health Industry Development Institute
研究点 (4)
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