UMIN-CTR Clinical Trial

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
Email	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
Email	uchikan@jikei.ac.jp

Sponsor
Institute	The Jikei University Kashiwa Hospital
Institute
Department

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022087