UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019103 |
|---|---|
| Receipt number | R000022087 |
| Scientific Title | Evaluation of efficacy and safety of the Qing Dai in patients with ulcerative colitis: A muticenter, double-blind, randomized controlled trial. |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2020/03/27 15:17:38 |
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Basic information
Public title
Evaluation of efficacy and safety of the Qing Dai in patients with ulcerative colitis: A muticenter, double-blind, randomized controlled trial.
Acronym
A muticenter, double-blind, randomized controlled trial of the Qing Dai.
Scientific Title
Evaluation of efficacy and safety of the Qing Dai in patients with ulcerative colitis: A muticenter, double-blind, randomized controlled trial.
Scientific Title:Acronym
A muticenter, double-blind, randomized controlled trial of the Qing Dai.
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The herbal medicine Qing Dai has traditionally been used in China for UC patients, but there is few scientific evaluation of its efficacy. We conduct a multicenter, double-blind study to evaluate efficacy and safety of the Qing Dai in patients with ulcerative colitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease activity index(Lichtiger index)
Key secondary outcomes
Endoscopic findings, Blood test, Adverse reactions
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Qing Dai:s weeks, 1000mg aday
Interventions/Control_2
rice starch
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
UC patients in mild to moderate active phase with intolerance or refractory with conventional treatments.
Key exclusion criteria
The patients with...
1. newly start or dose-up of 5-ASA within two weeks.
2. newly start or dose-up of steroids within two weeks.
3. newly start or dose-up of immunomodulators, such as azathioprine/6-methyl mercaptopurine within three months.
4. with biological products, such as Infliximab, and Adalimumab.
5. any herbal medicine containing the Qing Dai.
6. a possibility of pregnancy, during pregnancy, or lactating.
7. any mental illness that interfere to participate this trial.
8. active bacterial/fungal infections
9. history of myocardial infarction or unstable angina within three months.
10. uncontrollable hypertension
11. respiratery disease requiring a sustained oxigen administration.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kan Uchiyama |
Organization
The Jikei University Kashiwa Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
163-1 Kashiwa-shita, Kashiwa, Chiba, 277-8567, Japan
TEL
04-7164-1111
uchikan@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kan Uchiyama |
Organization
The Jikei University Kashiwa Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
163-1 Kashiwa-shita, Kashiwa, Chiba, 277-8567, Japan
TEL
04-7164-1111
Homepage URL
uchikan@jikei.ac.jp
Sponsor or person
Institute
The Jikei University Kashiwa Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba Graduate School
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
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 | 10 | Month | 01 | 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
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
Main results already published
Date of protocol fixation
| 2015 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 24 | Day |
Last modified on
| 2020 | 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=R000022087
