UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027381 |
|---|---|
| Receipt number | R000031377 |
| Scientific Title | Randomized, double-blind trial to show the efficacy of daiobotanpito as additional option in treating acute diverticulitis |
| Date of disclosure of the study information | 2017/05/18 |
| Last modified on | 2019/06/12 16:49:46 |
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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
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
okeiko@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Japanese-Traditional (Kampo) Medicine, Kanazawa University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031377
