UMIN-CTR Clinical Trial

Basic information
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
Condition	Acute diverticulitis of colon
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
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
Other related information	This study has been migrated to other databases.

Management information
Registered date	2017 Year 05 Month 18 Day
Last modified on	2019 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031377