Unique ID issued by UMIN | UMIN000017359 |
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Receipt number | R000020148 |
Scientific Title | Investigation of the safety of Indigo naturalis for the patients with ulcerative colitis |
Date of disclosure of the study information | 2015/05/01 |
Last modified on | 2015/04/30 23:42:44 |
Investigation of the safety of Indigo naturalis for the patients with ulcerative colitis
Investigation of the safety of Indigo naturalis for the patients with ulcerative colitis
Investigation of the safety of Indigo naturalis for the patients with ulcerative colitis
Investigation of the safety of Indigo naturalis for the patients with ulcerative colitis
Japan |
ulcerative colitis
Gastroenterology |
Others
NO
The aim of this study is to clarify the safety Indigo naturalis for the patients with ulcerative colitis
Efficacy
The existence of adverse effect
Clinical improvement rate
Improvement of the endoscopic findings
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Oral administration of Indigo naturalis
2g/day, 4 weeks
20 | years-old | <= |
95 | years-old | >= |
Male and Female
1)Patients with ulcerative colitis
2)Patients older than 20 years old
3)Patients with moderate to severe activity
4)Patients resistant to the existing therapy with 5-aminosalicylate, corticosteroids, or other drugs for ulcerative colitis
5)Patients with no change of drugs for at least 2 weeks before the enter to this study
6)Patients had not taken Indigo naturalis for 1 month before enrolling to this study
1)Patients with pregnancy or breastfeeding
2)Patients with mental illness
3)Patients with a disorder of liver or kidney
4)Patients taking antithrombotic or anticoagulant drugs, and patients with thrombocytopenia
5)Patients judged as inappropriate for the study because of their conditions
20
1st name | |
Middle name | |
Last name | Tetsuo Takehara |
Osaka University, Graduate School of Medicine
Department of Gastroenterology and Hepatology
2-2 Yamadaoka, Ssuita, Osaka
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Hideki Iijima |
Osaka University, Graduate School of Medicine
Department of Gastroenterology and Hepatology
2-2 Yamadaoka, Ssuita, Osaka
06-6879-3621
http://www.med.osaka-u.ac.jp/pub/gh/research_jisyu.html
hiijima@gh.med.osaka-u.ac.jp
Osaka University, Graduate School of Medicine,
Department of Gastroenterology and Hepatology
Osaka University, Graduate School of Medicine,
Department of Gastroenterology and Hepatology
Self funding
YES
14318
Ethics Committee of Osaka University Hospital
2015 | Year | 05 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2015 | Year | 02 | Month | 27 | Day |
2015 | Year | 05 | Month | 07 | Day |
2015 | Year | 04 | Month | 30 | Day |
2015 | Year | 04 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020148
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