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Recruitment status Completed
Unique ID issued by UMIN UMIN000014808
Receipt No. R000017214
Scientific Title The research on safety of traditional Japanese herbal (Kampo) medicine, daiobotanpito in the treatment of acute diverticulitis: an intervention trial
Date of disclosure of the study information 2014/08/09
Last modified on 2017/04/05

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Basic information
Public title The research on safety of traditional Japanese herbal (Kampo) medicine, daiobotanpito in the treatment of acute diverticulitis: an intervention trial
Acronym Safety of daiobotanpito in the treatment of acute diverticulitis
Scientific Title The research on safety of traditional Japanese herbal (Kampo) medicine, daiobotanpito in the treatment of acute diverticulitis: an intervention trial
Scientific Title:Acronym Safety of daiobotanpito in the treatment of acute diverticulitis
Region
Japan

Condition
Condition Diverticulitis
Classification by specialty
Gastroenterology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate of safety of daiobotanpito in the treatment of acute diverticulitis with antibiotics and fast.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Adverse events (type, frequency, and time of emergence)
Key secondary outcomes Duration of abdominal pain
Febrile period, and NSAID use
CRP and WBC
Size of abscess
Frequency of defecation
Aggravation
daiobotampito use
Antibiotics use
Timing to resume meal

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 daiobotanpito use
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with diverticulitis
2. Patients who have signed consent to participate in this research
Key exclusion criteria 1. High probability to perforate.
2. Diarrhea or soft stool.
3. Chronic appetite loss, abdominal pain or diarrhea.
4. Too friable.
5. Insulin use.
6. Immuno-compromised host.
7. Pregnant or puerperal.
8. Kidney disease (eGFR < 20 ml/min/1.73m^2).
9. Allergy to daiobotampito.
10. Experience to jpin in this trial before.
11. No abdominal pain and fever.
12. Doctor's diagnosis as inappropriate.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nakazawa, Atsushi
Organization Tokyo Saiseikai Central Hospital
Division name Gastrointestinal Medcine
Zip code
Address Mita 1-4-17, Minato-ku, Tokyo, Japan 108-0073
TEL 03-3451-8211
Email anakaza@b-star.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koike, Hiroshi
Organization Keio University School of Medicine
Division name Center for Kampo Medicine
Zip code
Address Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan 160-8582
TEL 03-5366-3824
Homepage URL
Email koike-h@umin.ac.jp

Sponsor
Institute Gastrointestinal Medcine, Tokyo Saiseikai Central Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Center for Kampo Medicine, Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2014 Year 08 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://online.liebertpub.com/doi/abs/10.1089/acm.2016.0367?journalCode=acm
Number of participants that the trial has enrolled
Results
Daiobotampito is a safe treatment option for acute, early stage diverticulitis.
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 Completed
Date of protocol fixation
2014 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 09 Day
Last modified on
2017 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017214


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