UMIN-CTR Clinical Trial

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
Last 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
1st 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