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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024917
Receipt No. 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

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Basic information
Public title Clinical Efficacy and Safety of Oral Qing-Dai in Patients
with Ulcerative Colitis
Acronym Clinical Efficacy and Safety of Oral Qing-Dai in Patients
with Ulcerative Colitis
Scientific Title Clinical Efficacy and Safety of Oral Qing-Dai in Patients
with Ulcerative Colitis
Scientific Title:Acronym 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
1st name
Middle name
Last name Hideki Kitada
Organization Kumamoto red cross hospital
Division name gastroenterology
Zip code
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
1st name
Middle name
Last name Tuyama Atuko
Organization Kumamoto red cross hospital
Division name division of clinical support
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2016 Year 11 Month 10 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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