A randomized, double-blind study on the effect of daiobotanpito as additional option in treating acute diverticulitis

JRCT ID: jRCTs041180063

Registered date:01/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: diverticulitis
• Date of first enrollment: 29/03/2018
• Target sample size: 170
• Study type: Interventional

Intervention(s)

Group A Standard Treatment + Placebo
Group B Standard Treatment + daiobotanpito
DBT extract (Tsumura, Tokyo) or placebo at 2.5g was administered three times a day, 7.5g per day for 10 days.

Outcome(s)

Primary Outcome

Primary endpoint
Treatment success rate
Our of the group to be analyzed, if criteria as below is satisfied, it is defined as treatment success.
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
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

Days of adminisutration
It shall be the number of days until discharge including the registration date, after the trial registration.
Change in inflammatory response (CRP, WBC, neutrophil count)
The difference between the value (baseline value) at the time of registration of each measurement value and the value at each measurement day.
Thermal type
Difference from the value (baseline value) at the time of registration of body temperature from the value at each measurement day.
Number of days to start oral ingestion
It shall be the number of days until the start of oral intake, including the registration date, after the trial registration.
Relapse rate (1 year follow-up observation)
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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

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.

Exclude criteria

(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.

Related Information

• Primary Sponsor: Ogawa Keiko
• Source(s) of Monetary Support: Japan Agency for Medical research and development