Unique ID issued by UMIN | UMIN000016526 |
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Receipt number | R000019190 |
Scientific Title | Investigation of safety and clinical usefulness of natural indigo for patients with active ulcerative colitis |
Date of disclosure of the study information | 2015/02/13 |
Last modified on | 2016/03/30 18:45:54 |
Investigation of safety and clinical usefulness of natural indigo for patients with active ulcerative colitis
Investigation of safety and clinical usefulness of natural indigo for patients with active ulcerative colitis
Investigation of safety and clinical usefulness of natural indigo for patients with active ulcerative colitis
Investigation of safety and clinical usefulness of natural indigo for patients with active ulcerative colitis
Japan |
ulcerative colitis
Gastroenterology | Adult |
Others
NO
The aim of this study is to clarify the safety and clinical efficacy of natural indigo in patients with active ulcerative colitis
Safety
The incidence of adverse effect
The rate of clinical improvement
he rate of clinical remission
The rate of endoscopic remission
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Quig-Dai
2g daily (1g/once twice a day)
Duration of treatment is 8 weeks
20 | years-old | <= |
90 | years-old | >= |
Male and Female
1 Patients have been diagnosed as ulcerative colitis (Japanese Criteria)
2 Patients with mild to moderate active disease
3 Age more than 20 years old
4 Informed consent has been obtained
1 Patients with colitis-associated dysplasia or cancer
2 Patients who are suspected with infectious colitis
3 Patients with severe colonic stenosis
4 Patients who needs colectomy after enroll of this study
5 Previous adverse effects to Chinese medicine
20
1st name | |
Middle name | |
Last name | Makoto Naganuma |
Keio University Hospital
Center for Diagnostic and Therapeutic Endoscopy
35Shinanomachi, Shinjuku-ku, Tokyo
03-3353-1211
nagamakoto@z7.keio.jp
1st name | |
Middle name | |
Last name | Makoto Naganuma |
Keio University Hospital
Center for Diagnostic and Therapeutic Endoscopy
35Shinanomachi, Shinjuku-ku, Tokyo
03-3353-1211
nagamakoto@z7.keio.jp
Makoto Naganuma
Disignate contribution
Self funding
NO
2015 | Year | 02 | Month | 13 | Day |
Published
We prospectively registered 10 patients with UC and finished to follow-up on August 8th.We have already analyzed the data for 10 patients and 10 more cases will be registered to evaluate the safety and clinical usefulness of Qing-Dai. Follow-up was finished on December 12. We have confirmed that rate of clinical remission and responder was 30% and 65%, respectively.
Completed
2014 | Year | 09 | Month | 13 | Day |
2015 | Year | 02 | Month | 13 | Day |
2015 | Year | 12 | Month | 12 | Day |
2015 | Year | 12 | Month | 12 | Day |
2015 | Year | 12 | Month | 15 | Day |
2015 | Year | 02 | Month | 13 | Day |
2016 | Year | 03 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019190
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