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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016526
Receipt No. 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

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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
Email 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
Email nagamakoto@z7.keio.jp

Sponsor
Institute Makoto Naganuma
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019190

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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