A randomized, double-blind study on the effect of daiobotanpito as additional option in treating acute diverticulitis
- Conditions
- diverticulitis
- Registration Number
- JPRN-jRCTs041180063
- Lead Sponsor
- Ogawa Keiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 170
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.
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint<br>Treatment success rate<br>Our of the group to be analyzed, if criteria as below is satisfied, it is defined as treatment success.<br>1) In case of patient with fever of 37.5 degrees and abdominal pain requiring treatment at the time of registration, both fever decrease and disappearance of abdominal pain are confirmed<br>2) In the case of patient with abdominal pain requiring treatment though there is no fever of 37.5 degrees or more at the time of registration, disappearance of abdominal pain is observed
- Secondary Outcome Measures
Name Time Method Days of adminisutration<br>It shall be the number of days until discharge including the registration date, after the trial registration.<br>Change in inflammatory response (CRP, WBC, neutrophil count)<br>The difference between the value (baseline value) at the time of registration of each measurement value and the value at each measurement day.<br>Thermal type<br>Difference from the value (baseline value) at the time of registration of body temperature from the value at each measurement day.<br>Number of days to start oral ingestion<br>It shall be the number of days until the start of oral intake, including the registration date, after the trial registration.<br>Relapse rate (1 year follow-up observation)<br>Among the group to be analyzed, the rate is assumed that the patient recurred diverticulitis by 1 year after the trial registration. It is regarded as recurrence when diagnosed as colon diverticulitis after discharge.