Unique ID issued by UMIN | UMIN000024917 |
---|---|
Receipt number | R000028345 |
Scientific Title | Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis |
Date of disclosure of the study information | 2016/12/03 |
Last modified on | 2016/11/29 15:19:33 |
Clinical Efficacy and Safety of Oral Qing-Dai in Patients
with Ulcerative Colitis
Clinical Efficacy and Safety of Oral Qing-Dai in Patients
with Ulcerative Colitis
Clinical Efficacy and Safety of Oral Qing-Dai in Patients
with Ulcerative Colitis
Clinical Efficacy and Safety of Oral Qing-Dai in Patients
with Ulcerative Colitis
Japan |
Ulcerative colitis
Gastroenterology |
Others
NO
To evaluate for clinical efficacy and safety of oral Qing-Dai in patients with ulcerative colitis
Safety,Efficacy
Exploratory
Pragmatic
Rate of clinical response at 12 weeks of treatment
The clinical response is defined as a decrease in the Mayo
score of 1 or more in each item.The overall safety is assessed by the patients and investigators during the visit to the clinic.
Rate of clinical remission and mucosal healing at 12weeks of treatment.Clinical remission is defined as a Mayo endoscopic score of 0 or 1 and other items of Mayo score of 0.Mucosal healing is defined as a Mayo endoscopic score of 0 or 1 .The serial changes in CAI score,Mayo score,partial Mayo score,Mayo endoscopic score,CRP are also
assessed.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
NO
1
Treatment
Medicine |
Oral Qing-Dai
patients from 7 to 11 : twice a day(daily dose,1g) for 12
weeks
patients from 12 to 14 :twice a day(daily dose,1.5g) for 12
weeks
patients 15 and over: twice a day(daily dose,2g) for 12
weeks
7 | years-old | <= |
80 | years-old | >= |
Male and Female
Patients from 7 to 80
Patients who had mild to moderate UC activity and were
diagnosed according to the diagnostic criteria defined by
the research group of inflammatory bowel disease in the
Ministry of Health,Labor and Welfare in Japan.
colitis associated dysplasia,
symptomatic intestinal stenosis
a history of side effect or allergy of Chinese herbal
medicine
a need for potential surgery after enrollment in this study
signs of other types of colitis,
severe liver ,heart or renal diseases; or a history of
malignant diseases, psychosomatic disorders,infectious
disease.
Pregnant or breastfeeding women.
The patients treated with leukocyte aphaeresis,prednisolone >=40mg,adalimumab,tacrolimus or cyclosporine within 2 weeks before the commencement of the study.
The patients treated with infliximab whitin 4 weeks before
the commencement of the study.
Changing the dose of mesalamine or prednisolone within 2 weeks before the commencement of the study.
The patients treated with thiopurine within 12 weeks
before the commencement of the study.
Changing the dose of thiopurine within 4weeks before the commencement of the study.
20
1st name | |
Middle name | |
Last name | Hideki Kitada |
Kumamoto red cross hospital
gastroenterology
2-1-1 Nagamineminami Kumamoto city Kumamoto prefecture
096-384-2111
h-kitada@kumamoto-med.jrc.or.jp
1st name | |
Middle name | |
Last name | Tuyama Atuko |
Kumamoto red cross hospital
division of clinical support
2-1-1 Nagamineminami Kumamoto city Kumamoto prefecture
096-384-2111
rinsyoukenkyu@kumamotro-med.jrc.or.jp
Kumamoto red cross hospital
division of gatroenterology
non
Self funding
NO
熊本赤十字病院(熊本県)
2016 | Year | 12 | Month | 03 | Day |
Unpublished
Preinitiation
2016 | Year | 11 | Month | 10 | Day |
2016 | Year | 12 | Month | 12 | Day |
2016 | Year | 11 | Month | 20 | Day |
2016 | Year | 11 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028345
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