UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of clinical efficacy of Qing-Dai for patients with crohn's disease who have the loss of responsiveness for anti-TNF agents
Title of the study (Brief title)	clinical efficacy of Qing-Dai for patients with crohn's disease
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	The rate of clinical remission (CDAI is less than 150 at 8 weeks after the entry)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Makoto Naganuma
Organization	School of Medicine, Keio University
Division name	Division of Gastroenterology and Hepatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	maknaganuma@gmail.com

Public contact
Name of contact person	Makoto Naganuma
Organization	School of Medicine, Keio University
Division name	Division of Gastroenterology and Hepatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	maknaganuma@gmail.com

Sponsor
Institute	Division of Gastroenterology and Hepatology, School of Medicine, Keio University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	Keio University Hospital

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 06 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 10 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 06 Day
Last modified on	2018 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022250