UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016526 |
|---|---|
| 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 |
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Basic information
Public title
Investigation of safety and clinical usefulness of natural indigo for patients with active ulcerative colitis
Acronym
Investigation of safety and clinical usefulness of natural indigo for patients with active ulcerative colitis
Scientific Title
Investigation of safety and clinical usefulness of natural indigo for patients with active ulcerative colitis
Scientific Title:Acronym
Investigation of safety and clinical usefulness of natural indigo for patients with active ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the safety and clinical efficacy of natural indigo in patients with active ulcerative colitis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of adverse effect
The rate of clinical improvement
Key secondary outcomes
he rate of clinical remission
The rate of endoscopic remission
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
| Medicine |
Interventions/Control_1
Quig-Dai
2g daily (1g/once twice a day)
Duration of treatment is 8 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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Naganuma |
Organization
Keio University Hospital
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address
35Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
nagamakoto@z7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Naganuma |
Organization
Keio University Hospital
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address
35Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
nagamakoto@z7.keio.jp
Sponsor or person
Institute
Makoto Naganuma
Institute
Department
Personal name
Funding Source
Organization
Disignate contribution
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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.
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
| 2014 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 12 | Month | 12 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 13 | Day |
Last modified on
| 2016 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019190
