UMIN-CTR Clinical Trial

Public title

Investigation of clinical efficacy of Qing-Dai for patients with crohn's disease who have the loss of responsiveness for anti-TNF agents

Acronym

clinical efficacy of Qing-Dai for patients with crohn's disease

Scientific Title

Investigation of clinical efficacy of Qing-Dai for patients with crohn's disease who have the loss of responsiveness for anti-TNF agents

Scientific Title:Acronym

clinical efficacy of Qing-Dai for patients with crohn's disease

Region

Japan

Condition

Crohn's disease

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to assess the clinical efficacy and safety of Qing-Dai in patients with Crohn's disease who have the loss of responsiveness for anti-TNF agents

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

The rate of clinical remission (CDAI is less than 150 at 8 weeks after the entry)

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Eight weeks treatment of Qing-Dai (2g daily)

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

Age-lower limit

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1 Japanese patient who is aged more than15 years
2 Patients 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.
3 Patients induced clinical remission by infliximab or adalimumab once, and then infliximab or adalimumab was used at least for 16 weeks after starting ofinfliximab or adalimumab.
4 Patients' CDAI was more than 175 at the entry and at last administration of infliximab or adalimumab

Key exclusion criteria

1 Patients' CDAI was more than 450 or less than 150 at the entry
2 The patients were not treated with infliximab within 7 weeks. The patients were not treated with adalimumab within 10 days.
3 The presence of abdominal abscess
4 Patients had colitis-associated dysplasia.
5 Patients had symptomatic intestinal stenosis
6 Patients had pouch or stoma.
7 Patients have the history of side effect or allergy of Chinese herbal medicine.
8 Patients have serious infections.
9 Patients have serious heart disease
10 Serum creatinine is more than 2.0mg/dL
11 Total bilirubin is more than 2.0mg/dL or AST/ALT is more than 50IU/L
12 Patients have history of malignant diseases
13 Patients have obvious psychological disorders
14 Patients are pregnant or patients wish to conceive.
15 Changing the dose/addition/reduction of medication for CD within 12 weeks before the commencement of the study was not allowed.
16 Investigators regard the patients as the inappropriate person to enroll this clinical trial.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Makoto Naganuma

Organization

School of Medicine, Keio University

Division name

Division of Gastroenterology and Hepatology

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Email

maknaganuma@gmail.com

Name of contact person

1st name
Middle name
Last name	Makoto Naganuma

Organization

School of Medicine, Keio University

Division name

Division of Gastroenterology and Hepatology

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Homepage URL

Email

maknaganuma@gmail.com

Institute

Division of Gastroenterology and Hepatology, School of Medicine, Keio University

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Keio University Hospital

Date of disclosure of the study information

2015

Year

10

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2015

Year

10

Month

05

Day

Date of IRB

Anticipated trial start date

2015

Year

10

Month

15

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

10

Month

06

Day

Last modified on

2018

Year

04

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022250