UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029633
Receipt No. R000033842
Scientific Title The efficacy of indigo naturalis-containing suppository in patients with active ulcerative colitis.
Date of disclosure of the study information 2017/10/20
Last modified on 2019/03/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The efficacy of indigo naturalis-containing suppository in patients with active ulcerative colitis.
Acronym The efficacy of indigo naturalis-containing suppository in patients with active ulcerative colitis.
Scientific Title The efficacy of indigo naturalis-containing suppository in patients with active ulcerative colitis.
Scientific Title:Acronym The efficacy of indigo naturalis-containing suppository in patients with active ulcerative colitis.
Region
Japan

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

Objectives
Narrative objectives1 The assessment of safety and efficacy of the suppository, which contains 0.05g indigo naturalis, in patients with ulcerative colitis for 4 weeks
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety for 4 weeks after starting the treatment
Key secondary outcomes

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 administration of the suppository ,which contains 0.05g indigo naturalis, for 4 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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients who are applied to the diagnostic criteria of ulcerative colitis(UC).
2)Patients with 2 points or more partial Mayo score.
3)Patients who only have proctitis with 2 points or more endoscopic Mayo score, or patients who have 0 or 1 points from discending colon to cecum.
4)18-year-old or older patients who agreed to this trial, and when patients who are younger than 20 years old, their
legal representatives also have to agree to the trial.
Key exclusion criteria 1.Patients who are clinically classified into severe or fulminant condition or have other conditions besides UC,such as infectious enteritis and so on. 2.Patients with symptomatic stenosis. 3.Patients who are planned to undergo surgery or patients who have experienced adverse effect or allergy of herbal medicines, and patients who have had herbal medicine which contains IN. 4.Patients with severe infection, severe heart disease,2.0 mg per dl or higher serum creatinine levels,2.0mg per dl or higher serum total bilirubin levels, 50IU per l or higher serum AST and ALT levels, malignant tumor or its previous history,and neuropsychiatric disorders. 5.Patients who have possibility of pregnancy, or patients in nursing, or patients who hope to get pregnant. 6.Patients who are decided to be inappropriate for other reason by attending doctors. 7.Exclusion criteria about concomitant drugs. Changing dose of oral 5 aminosalicylate(5ASA)within 2 weeks before registration.Use of suppository or enema of 5-ASA or steroid within 2 weeks before registration.Receiving Granulocyte Monocyte Apheresis within 2 weeks before registration.Starting immunomodulators (azathioprine and 6-mercaptopurine),and changing dose of them within 4 weeks before registration.Use of 20mg or more of oral prednisolone or equivalent corticosteroid (the route: intravenous, intra-arterial , or intramuscular administration) within 2 weeks before registration. As for patients who receive 20mg or less oral prednisolone (or equivalent corticosteroid), changing dose or administration of oral prednisolone within 2 weeks before registration.Use of adalimumab within 4 weeks before registration.Use of infliximab or vedolizumab within 8 weeks before registration.Use of ustekinumab or herbal medicines other than IN within 12 weeks before registration.Use of cyclosporine (oral or intravenous administration) or tacrolimus (except for eye drops) within 2 weeks before registration.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Takanori
Middle name
Last name Kanai
Organization Keio University School of Medicine
Division name Gastroenterology and Hepatology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL 03-3353-1211
Email takagast@z2.keio.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Naganuma
Organization Keio University School of Medicine
Division name Gastroenterology and Hepatology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL 03-3353-1211
Homepage URL
Email maknaganuma@gmail.com

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization self-sustaining fund
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 Keio University School of Medicine
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel 03-3353-1211
Email yyyy1y8yyyy@keio.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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 20 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 10
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
2017 Year 10 Month 10 Day
Date of IRB
2017 Year 12 Month 25 Day
Anticipated trial start date
2017 Year 12 Month 27 Day
Last follow-up date
2019 Year 03 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 19 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033842

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.