UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022575 |
|---|---|
| Receipt number | R000025908 |
| Scientific Title | Clinical efficacy and safety of oral Qing-Dai in patients with inflammatory bowel disease |
| Date of disclosure of the study information | 2016/06/02 |
| Last modified on | 2019/05/20 13:37:00 |
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Basic information
Public title
Clinical efficacy and safety of oral Qing-Dai in patients with inflammatory bowel disease
Acronym
Clinical efficacy and safety of oral Qing-Dai in patients with inflammatory bowel disease
Scientific Title
Clinical efficacy and safety of oral Qing-Dai in patients with inflammatory bowel disease
Scientific Title:Acronym
Clinical efficacy and safety of oral Qing-Dai in patients with inflammatory bowel disease
Region
| Japan |
Condition
Condition
Ulcerative colitis,Crohn disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of oral Qing-Dai in patients with inflammatory bowel disease
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The rate of clinical remission at 4 weeks
Key secondary outcomes
1)The rate of clinical response and mucosal healing at 4 weeks
2)The rate of maintaining clinical remission,clinical response and mucosal healing at 52 weeks
3)Side effects of oral Qing-Dai
4)The changes of mucosal miRNA,microbiota,and inflammatory cytokines
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Patients take oral Qing-Dai in capsule form twice a day(daily dose,2g)for 4 weeks.If patients achieve clinical remission or show clinical response,they will be allowed to continue taking these drugs for 52 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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who have moderate to severe active ulcerative colitis(Left-sided or Extensive type,CAI=>6) or Crohn disease(CDAI=>220)
2)Adult patients
3)Patients with no change in treatment within the past 2 weeks before the commencement of the study
4)Patients who have never been treated with Qing-Dai
5)Patients who have received adequate information regarding this study and understood throughly,and then voluntarily submitted written consent forms upon participation in this study
Key exclusion criteria
1)Pregnant or breastfeeding women
2)Patients who have a history of psychosomatic disorders
3)Patients who have a history of liver or renal diseases
4)Patients who have a history of antithrombotic therapy or thrombocytopenia
5)Patients who have a history of hepatitis B
6)Patients whom investigators and subinvestigators considered inappropriate to participate in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takanari |
| Middle name | |
| Last name | Kitazono |
Organization
Graduate School of Medical Sciences,Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
812-8582
Address
Maidashi 3-1-1,Higashi-ku,Fukuoka
TEL
092-642-5261
kitazono@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Hirano |
Organization
Graduate School of Medical Sciences,Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
812-8582
Address
Maidashi 3-1-1,Higashi-ku,Fukuoka
TEL
092-642-5261
Homepage URL
http://www.gut.med.kyushu-u.ac.jp/news/detail/?id=9
atsuhira@intmed2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KYUSHU UNIVERSITY Center for Clinical and Translational Research(CCTR)
Address
3-1-1 Maidashi, Higashi-ku
Tel
092-642-5774
byskenkyu@jimu.kyushu-u.ac.jp
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
九州大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 02 | 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
33
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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 01 | Day |
Last modified on
| 2019 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025908
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| Registered date | File name |
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