The Beneficial Effect of the Traditional Japanese Medicine, Keishi-ka-shakuyaku-daio-to（TJ-134）for Patients With Symptomatic Pneumatosis Cystoides
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of computed tomography (CT) findings
研究概览
简要总结
The traditional Japanese medicine, Keishi-ka-shakuyaku-daio-to is administered to patients with symptomatic pneumatosis cystoides intestinalis (PCI) as compared with lactomin for 8 weeks.
详细描述
- Based on endoscopic finding, patients with symptomatic PCI are recruited.
- After enrollment, abdominal symptoms are evaluated and abdominal CT is performed.
- Patients were randomized in a 1:1 ratio in blocks of 4 to undergo either the traditional Japanese medicine or lactomin (control). Randomization was carried out by computer-generated random sequences.
- The traditional Japanese medicine, Keishi-ka-shakuyaku-daio-to（TJ-134, 7.5g/day), which consists of a mixture of a compound of peony root (6 g), cinnamon bark (4 g), jujube (4 g), glycyrrhiza (2 g), rhubarb (2 g), and ginger (1 g) or lactomin (3g/day) is administered to enrolled patients for 8 weeks.
- After the administration of each drug for 8 weeks, abdominal symptoms are evaluated and abdominal CT is performed again.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •typical findings of PCI on colonoscopy; Line or pebble like sessile cysts are distributed around the colon with normal overlying mucosa
排除标准
- •patients can not take Keishi-ka-shakuyaku-daio-to（TJ-134）
研究组 & 干预措施
TJ-134 group
The traditional Japanese medicine, Keishi-ka-shakuyaku-daio-to（TJ-134, 7.5g/day), which consists of a mixture of a compound of peony root (6 g), cinnamon bark (4 g), jujube (4 g), glycyrrhiza (2 g), rhubarb (2 g), and ginger (1 g) is administered to enrolled patients for 8 weeks.
干预措施: Japanese traditional medicine group (Drug)
Lactomin group
Lactomin (3g/day) is administered to enrolled patients for 8 weeks.
干预措施: Japanese traditional medicine group (Drug)
结局指标
主要结局
Change of computed tomography (CT) findings
时间窗: at enrollment and 8 weeks after the administration of TJ134
Change of the intraluminal gas pockets in the colon on CT images before and after the administration of TJ-134
次要结局
- Bloating and abdominal pain(at enrollment and 8 weeks after the administration of TJ134)
- Abdominal symptoms(at enrollment and 8 weeks after the administration of TJ134)
研究者
Akira Horiuchi
Chief of Digestive Disease Center
Showa Inan General Hospital