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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021439
Receipt No. R000024720
Scientific Title Usefulness of Qing-Dai for active ulcerative colitis
Date of disclosure of the study information 2016/03/11
Last modified on 2017/11/27

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Basic information
Public title Usefulness of Qing-Dai for active ulcerative colitis
Acronym Usefulness of Qing-Dai
Scientific Title Usefulness of Qing-Dai for active ulcerative colitis
Scientific Title:Acronym Usefulness of Qing-Dai
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of clinical efficacy and safety of Qing-Dai for ulcerative colitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rates of clinical response at week 8
(defined as decrease in the Mayo score of at least 3 points and a decrease of at least 30% from the baseline score, with a decrease of at least 1 point on the rectal bleeding subscore or an absolute rectal bleeding subscore of 0 or 1.)
Key secondary outcomes 1) Rates of clinical remission at week 8
2) Changes of the Mayo score between baseline and week 8
3) Rates of endoscopic remission at week 8
4) Changes of the partial Mayo score between baseline and week 4 or week 8
5) Changes of Lichtiger score between baseline and week 4 or week 8
6) Changes of quantitative fecal blood test between baseline and week 8
7) significance of fecal calprotectin level between baseline and week 8

Before we finished to fix the data, some following items of secondary endpoints were added
1) Changes of the CRP, serum ALB between baseline and week2 or, week 4,or week 8
2) Changes of the partial Mayo score, Lichtiger score between baseline and week 2
3) The rate of patients whose quantitative fecal blood test was less than 100 was compared among each group.
4) The rate of patients whose fecal calprotectin test was less than 100 was compared among each group.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Qing-Dai (2g daily) for 8 weeks
Interventions/Control_2 Qing-Dai (1g daily) for 8 weeks
Interventions/Control_3 Qing-Dai (0.5g daily) for 8 weeks
Interventions/Control_4 Placebo for 8 weeks
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 1 Patients who fullfil diagnostic criteria of ulcerative colitis
2 Patients with Mayo score of at least 6 and Mayo endoscopic score of at least 2
3 Patients are at least 16 years of age
4 Written consent is obtained from patients (from legal guardian if patient's age< 20 years old
Key exclusion criteria 1 Patients with severe or fulminate activity
2 Patients with proctitis
3 Patients who have signs of other types of colitis
4 Patients with symptomatic GI stenosis
5 The doctor have a plan to conduct colectomy
6 Patients with a history of side effect or allergy of Chinese herbal medicine, or with previous usage of medication including Qing Dai for ulcerative colitis
7 Patients who have severe infection
8 Patients who have severe heart disease
9 Patients with serum creatinine level of at least 2.0 mg/dL
10 Patients with total bilirubin level of at least 2.0 mg/dL or with ALT/AST levels of at least 50IU/l
11 Patients with a history of malignant diseases
12 Patients with apparent pshycological disorders
13 Pregnant patients, or patients who breast feed to baby or patients who conceive conception
14 Doctor judges inadequate patients to be enrolled into the clinical trial
15 Exclusion criteria of concomittent medication:
Changing the dose of mesalamine within 1 week before the commencement of the study was not allowed.
The patients were not treated with topical mesalamine/steroid within 1 week before the commencement of the study.
The patients were not treated with leukocytapheresis, prednisolone > 40 mg, tacrolimus, cyclosporine, or Chinese herbal medicine within 2 weeks before the commencement of the study.
Concomitant treatment with thiopurine, started more than 4 weeks before the commencement of the study, was allowed if that dosage had been stable for at least 4 weeks before the study was conducted.
The patients were not treated with adalimumab within 4 weeks or infliximab within 8 weeks before the commencement of the study.
Target sample size 120

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

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Naganuma
Organization School of Medicine, Keio University
Division name Department of Gastroenterology and Hematology
Zip code
Address 35 Shinanomachi, Shunjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email nagamakoto@z7.keio.jp

Sponsor
Institute School of Medicine, Keio University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 03 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.gastrojournal.org/article/S0016-5085(17)36382-5/fulltext
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 12 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 12 Day
Last follow-up date
2017 Year 02 Month 10 Day
Date of closure to data entry
2017 Year 02 Month 22 Day
Date trial data considered complete
2017 Year 03 Month 06 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 11 Day
Last modified on
2017 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024720

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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