JPRN-jRCTs041180063进行中（未招募）3 期
A randomized, double-blind study on the effect of daiobotanpito as additional option in treating acute diverticulitis - DADIDA trial
Ogawa Keiko0 个研究点目标入组 170 人开始时间: 2019年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 75age old（—）
- 性别
- All
入选标准
- •Participants who meet the following criteria are eligible
- •(a) Moderate to severe diverticulitis
- •Diagnosis was based on the image of Computed Tomography (CT),
- •diverticulalike structure in accordance with tenderness or abdominal pain, a thickening of colon wall, signs of inflammation of the pericolonic fat, the tissue density, and vascular involvement. Pericolonic abscess, free air or extravasation, and accumulation of fluid were also noticed to predict prognosis.
- •(b)At least 20 years old and under 75 years old
- •(c)Patients who can communicate with each other
- •(d)Patients with abdominal pain and/or fever above 37.5 degrees
- •(e)After receiving sufficient explanation for the participation of this study, after sufficient understanding, the patient's willingness to freely by written agreement to be obtained.
排除标准
- •(a) Patients with severe dysfunction in the following organs.
- •(Blood tests are allowed within 4 weeks before treatment starts)
- •Renal function: serum creatinine value> 1.5 times the upper limit of institution standard
- •Liver function: serum AST value or serum ALT value> 3 times the facility reference upper limit value
- •Central nervous function: encephalopathy or a patient suspected of it
- •Electrolyte: serum Na <125 mEq / L, serum K <3.3 mEq / L
- •(b) Patients considered highly likely to have perforation of abscess due to malnutrition (Alb <2.5 g / dL)
- •(c) Patients with obstructive ileus symptoms
- •(d) Patients who have chronic anorexia, abdominal pain, diarrhea symptoms before the onset of coloren diverticulitis
- •(e) Before the onset of colorectal diverticulitis, Performance Status (PS), one of the indicators of the general condition and the degree of restriction of the patient's daily life, is 3 or above
- •(f) Patients who have taken history of DBT
- •(g) Patients being treated by insulin preparations
- •(h) Immunocompromised patients
- •(i) Pregnant women and puerperium period
- •(j) Patients with advanced allergy to Kampo formulas
- •(k) Patients who the doctor considers inappropriate for being included in this study.
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