Unique ID issued by UMIN | UMIN000024685 |
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Receipt number | R000025929 |
Scientific Title | Efficacy of daiobotampito in the treatment of acute diverticulitis of colon: a single-center open-label randomized controlled trial |
Date of disclosure of the study information | 2016/12/01 |
Last modified on | 2017/04/05 07:23:52 |
Efficacy of daiobotampito in the treatment of acute diverticulitis of colon: a single-center open-label randomized controlled trial
Trial about efficacy of daiobotampito in the treatment of acute diverticulitis
Efficacy of daiobotampito in the treatment of acute diverticulitis of colon: a single-center open-label randomized controlled trial
Trial about efficacy of daiobotampito in the treatment of acute diverticulitis
Japan |
diverticulitis of colon
Gastroenterology | Infectious disease |
Others
NO
Evaluation of efficacy of daiobotampito in the treatment of diverticulitis
Efficacy
Confirmatory
Phase III
Visual analogue scale (VAS) of abdominal pain on day 3
VAS of abdominal pain other than day 3
Day on which VAS of pain becomes equal to or less than 50 mm
Frequency of stool
Frequency of ingravescence of diverticulitis, which patients need operation
Frequency of adverse event
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Medicine |
Patients are treated with fasting, antibacterial agents, and 7.5g per day of daiobotampito extract (Tsumura co.) for 10 days or not.
Patients are treated with fasting, antibacterial agents. They are not treated with daiobotampito extract.
20 | years-old | <= |
75 | years-old | >= |
Male and Female
Patients with diverticulitis who have strong pain (VAS > 50mm)
High probability to perforate.
Diarrhea or soft stool.
Chronic appetite loss, abdominal pain or diarrhea.
Too friable.
Insulin use.
Immuno-compromised host.
Pregnant or puerperal.
Kidney disease (eGFR < 20 ml/min/1.73m^2).
Allergy to daiobotampito.
Experience to join in this trial before.
Doctor's diagnosis as inappropriate.
60
1st name | |
Middle name | |
Last name | Nakazawa, Atsushi |
Tokyo Saiseikai Central Hospital
Gastrointestinal Medcine
Mita 1-4-17, Minato-ku, Tokyo, Japan 108-0073
03-3451-8211
anakaza@b-star.jp
1st name | |
Middle name | |
Last name | Koike, Hiroshi |
Tokyo Saiseikai Central Hospital
General Internal Medcine
Mita 1-4-17, Minato-ku, Tokyo, Japan 108-0073
03-3451-8211
koike-h@umin.ac.jp
Gastrointestinal Medcine, Tokyo Saiseikai Central Hospital
Keio University
Self funding
Center for Kampo Medicine, Keio University School of Medicine
NO
2016 | Year | 12 | Month | 01 | Day |
Unpublished
Open public recruiting
2016 | Year | 12 | Month | 01 | Day |
2016 | Year | 12 | Month | 02 | Day |
2016 | Year | 11 | Month | 02 | Day |
2017 | Year | 04 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025929
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