UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029633 |
|---|---|
| Receipt number | 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 19:01:26 |
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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
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
maknaganuma@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033842
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