UMIN-CTR Clinical Trial

Public title

Randomized, double-blind trial to show the efficacy of daiobotanpito as additional option in treating acute diverticulitis

Acronym

RCT to show the efficacy of daiobotanpito as additional option in treating acute diverticulitis

Scientific Title

Randomized, double-blind trial to show the efficacy of daiobotanpito as additional option in treating acute diverticulitis

Scientific Title:Acronym

RCT to show the efficacy of daiobotanpito as additional option in treating acute diverticulitis

Region

Japan

Condition

Acute diverticulitis of colon

Classification by specialty

Gastroenterology

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In traditional Japanese herbal (Kampo) medicine, daiobotanpito (DBT) or Da Huang Mu Dan Tang in Chinese has been used in medical treatment of acute diverticulitis for many years based on the experience. Our former study investigated the treatment of acute diverticulitis can be treated with intravenous antibiotics plus orally administrated DBT than intravenous antibiotics alone. A retrospective non-randomized open-label trial was established to compare patients with acute diverticulitis who received oral DBT associated with intravenous antibiotics with those who received intravenous antibiotic alone. There was a significantly better outcome in the group treated with DBT than in the group without DBT when comparing duration of fever, abdominal pain, and antibiotics administration. A trend toward a day shorter mean hospital stay and fasting was seen in group 1, although this did not reach statistical significance. From this result, we assumed that most patients with acute diverticulitis can be managed safely with oral DBT. In this study, randomized, double-blind study will be done to show the possibility to use daiobotanpito as additional option in treating acute diverticulitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I

Primary outcomes

Rate of fever-down (below 38 degrees) within 3 days

Key secondary outcomes

Hospitalization days
Changes in inflammatory response
Number of days before oral intake
Recurrence rate
Rate to loss abdominal pain within 4 days
Types and frequencies of adverse events or side effects

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

daiobotanpito

Interventions/Control_2

placebo

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Moderate to severe diverticulitis Diagnosis will be based on computed tomography images: diverticula-like structure combined with tenderness or abdominal pain, a thickening of colon wall, signs of inflammation of pericolonic fat, tissue density, and vascular involvement. Pericolonic abscess, free air or extravasation, and accumulation of fluid will also be assessed to predict prognosis.
2. Age of at least 20 years and less than 75 years
3. Patients must be able to communicate with the investigators
4. Patients with abdominal pain and/or fever > 37.5 degree
5. After receiving sufficient explanation for participation in this study and achieving sufficient understanding, patients who provide written informed consent for participation.

Key exclusion criteria

1. Patients with severe dysfunction in the following organs, based on blood tests within four weeks before treatment starts
Renal function
serum creatinine value 1.5-fold greater than the upper limit of the institutional standard
Liver function
serum AST value or serum ALT value 3-fold greater than the upper limit of the institutional standard
Central nervous function
encephalopathy or a patient suspected of it
Electrolytes
serum sodium less than 125, serum potassium less than 3.3
2. Patients considered highly likely to exhibit abscess perforation due to malnutrition, serum Albumin less than 2.5
3. Patients with symptoms of obstructive ileus
4. Patients who exhibit chronic anorexia, abdominal pain, and/or diarrhea symptoms before the onset of colorectal diverticulitis
5. Before the onset of colorectal diverticulitis, performance status, an indicator of general condition and the degree of restriction of the patient's daily life, of more than three
6. Patients who have a history of DBT administration
7. Patients undergoing treatment with insulin preparations
8. Immunocompromised patients
9. Pregnant women and those in the postpartum period
10. Patients with advanced allergy to Kampo formulas
11. Patients who the doctor considers to be inappropriate for inclusion in this study.

Target sample size

170

Name of lead principal investigator

1st name
Middle name
Last name	Keiko Ogawa

Organization

Kanazawa University Hospital

Division name

Department of Japanese-Traditional (Kampo) medicine

Zip code

Address

13-1,Takara-machi, Kanazawa

TEL

076-265-2918

Email

okeiko@med.kanazawa-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Keiko Ogawa

Organization

Kanazawa University Hospital

Division name

Department of Japanese-Traditional (Kampo) medicine

Zip code

Address

13-1,Takara-machi, Kanazawa

TEL

076-265-2918

Homepage URL

Email

okeiko@med.kanazawa-u.ac.jp

Institute

Department of Japanese-Traditional (Kampo) Medicine, Kanazawa University Hospital

Institute

Department

Personal name

Organization

AMED

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

05

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2017

Year

05

Month

15

Day

Date of IRB

2017

Year

04

Month

27

Day

Anticipated trial start date

2017

Year

10

Month

01

Day

Last follow-up date

2021

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study has been migrated to other databases.

Registered date

2017

Year

05

Month

18

Day

Last modified on

2019

Year

06

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031377