JPRN-jRCTs031180206已完成4 期
The exploratory study for the efficacy and the safety of Rikkunshito on symptoms of indigestion in the patients with Functional Heartburn
Iwakiri Katsuhiko0 个研究点目标入组 10 人开始时间: 2019年3月7日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
Publish in the paper
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Patients diagnosed with FH according to the Rome IV criteria
- •(2)Patients with indigestion(ARD>=1)
- •(3) FSSG is>=8
- •(4)Patients who are resistant to even more than 2 weeks administration of P-CAB.
- •(5) Type of visit: Outpatient
- •(6) Patients for whom oral administration was possible
- •(7) Patients who provided written informed consent regarding study participation
排除标准
- •(1)Patients diagnosed with Eosinophilic esophagitis(EoE)
- •(2)Patients diagnosed with Esophageal Motility disorders by High-Resolution manometry.
- •(3)Patients who had 50% or more of Symptom Index by 24-hour Esophageal Impedance and PH monitoring.
- •(4)Patients diagnosed with Reflux esophagitis (RE) (Los Angeles classification,>=Grade A)by upper endoscopy.
- •(5)History of upper GI resection
- •(6)Confirmed presence of ulcer (excluding scars) or malignant tumor in the upper GI.
- •(7)Suspected organic hepatic/biliary/pancreatic disorders such as gallstone, hepatitis, and pancreatitis
- •(8)History of allergic reactions to Kampo medicines.
- •(9)Patients who were administered Kampo medicine 4 weeks before entry.
- •(10)Receiving or scheduled to receive an agent that is being developed.
- •(11)Presence of serious complications (liver, kidney, heart, or blood disease or metabolic disease).
- •(12)Pregnant or lactating women or those who are planning to conceive during the study period.
- •(13)Considered ineligible to participate by principal investigator or sub-investigator
研究者
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