UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024917
Receipt number R000028345
Scientific Title Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis
Date of disclosure of the study information 2016/12/03
Last modified on 2016/11/29 15:19:33

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Basic information

Public title

Clinical Efficacy and Safety of Oral Qing-Dai in Patients
with Ulcerative Colitis

Acronym

Clinical Efficacy and Safety of Oral Qing-Dai in Patients
with Ulcerative Colitis

Scientific Title

Clinical Efficacy and Safety of Oral Qing-Dai in Patients
with Ulcerative Colitis

Scientific Title:Acronym

Clinical Efficacy and Safety of Oral Qing-Dai in Patients
with Ulcerative Colitis

Region

Japan


Condition

Condition

Ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate for clinical efficacy and safety of oral Qing-Dai in patients with ulcerative colitis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Rate of clinical response at 12 weeks of treatment
The clinical response is defined as a decrease in the Mayo
score of 1 or more in each item.The overall safety is assessed by the patients and investigators during the visit to the clinic.

Key secondary outcomes

Rate of clinical remission and mucosal healing at 12weeks of treatment.Clinical remission is defined as a Mayo endoscopic score of 0 or 1 and other items of Mayo score of 0.Mucosal healing is defined as a Mayo endoscopic score of 0 or 1 .The serial changes in CAI score,Mayo score,partial Mayo score,Mayo endoscopic score,CRP are also
assessed.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Oral Qing-Dai
patients from 7 to 11 : twice a day(daily dose,1g) for 12
weeks
patients from 12 to 14 :twice a day(daily dose,1.5g) for 12
weeks
patients 15 and over: twice a day(daily dose,2g) for 12
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

7 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients from 7 to 80
Patients who had mild to moderate UC activity and were
diagnosed according to the diagnostic criteria defined by
the research group of inflammatory bowel disease in the
Ministry of Health,Labor and Welfare in Japan.

Key exclusion criteria

colitis associated dysplasia,
symptomatic intestinal stenosis
a history of side effect or allergy of Chinese herbal
medicine
a need for potential surgery after enrollment in this study
signs of other types of colitis,
severe liver ,heart or renal diseases; or a history of
malignant diseases, psychosomatic disorders,infectious
disease.
Pregnant or breastfeeding women.
The patients treated with leukocyte aphaeresis,prednisolone >=40mg,adalimumab,tacrolimus or cyclosporine within 2 weeks before the commencement of the study.
The patients treated with infliximab whitin 4 weeks before
the commencement of the study.
Changing the dose of mesalamine or prednisolone within 2 weeks before the commencement of the study.
The patients treated with thiopurine within 12 weeks
before the commencement of the study.
Changing the dose of thiopurine within 4weeks before the commencement of the study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideki Kitada

Organization

Kumamoto red cross hospital

Division name

gastroenterology

Zip code


Address

2-1-1 Nagamineminami Kumamoto city Kumamoto prefecture

TEL

096-384-2111

Email

h-kitada@kumamoto-med.jrc.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tuyama Atuko

Organization

Kumamoto red cross hospital

Division name

division of clinical support

Zip code


Address

2-1-1 Nagamineminami Kumamoto city Kumamoto prefecture

TEL

096-384-2111

Homepage URL


Email

rinsyoukenkyu@kumamotro-med.jrc.or.jp


Sponsor or person

Institute

Kumamoto red cross hospital
division of gatroenterology

Institute

Department

Personal name



Funding Source

Organization

non

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

熊本赤十字病院(熊本県)


Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 03 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

Preinitiation

Date of protocol fixation

2016 Year 11 Month 10 Day

Date of IRB


Anticipated trial start date

2016 Year 12 Month 12 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 11 Month 20 Day

Last modified on

2016 Year 11 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028345


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name