UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis
Title of the study (Brief title)	Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate for clinical efficacy and safety of oral Qing-Dai in patients with ulcerative colitis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	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.
Key secondary outcomes	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.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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
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

Eligibility
Age-lower limit	7 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	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.
Key exclusion criteria	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.
Target sample size	20

Research contact person
Name of lead principal investigator	Hideki Kitada
Organization	Kumamoto red cross hospital
Division name	gastroenterology
Address	2-1-1 Nagamineminami Kumamoto city Kumamoto prefecture
TEL	096-384-2111
Email	h-kitada@kumamoto-med.jrc.or.jp

Public contact
Name of contact person	Tuyama Atuko
Organization	Kumamoto red cross hospital
Division name	division of clinical support
Address	2-1-1 Nagamineminami Kumamoto city Kumamoto prefecture
TEL	096-384-2111
Homepage URL
Email	rinsyoukenkyu@kumamotro-med.jrc.or.jp

Sponsor
Institute	Kumamoto red cross hospital division of gatroenterology
Institute
Department

Funding Source
Organization	non
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	熊本赤十字病院（熊本県）

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 03 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 11 Month 10 Day
Anticipated trial start date	2016 Year 12 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 20 Day
Last modified on	2016 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028345