UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of clinical usefulness of natural indigo ointment for patients with inflammatory bowel disease
Acronym	Investigation of clinical usefulness of natural indigo ointment for patients with inflammatory bowel disease
Scientific Title	Investigation of clinical usefulness of natural indigo ointment for patients with inflammatory bowel disease
Scientific Title:Acronym	Investigation of clinical usefulness of natural indigo ointment for patients with inflammatory bowel disease
Region	Japan

Condition
Condition	Inflammatory bowel disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify the feasibility, the safety and clinical efficacy of natural indigo ointment in patients with inflammatory bowel disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Feasibility
Key secondary outcomes	Safety and Efficacy

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	Food
Interventions/Control_1	Quig-Dai ointment Three times a day Duration of treatment is 1 week
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who is receiving chemotherapy for cancer. 2. Patients with Grade 1 or 2 chemotherapy induced oral mucositis. 3. Age more than 20 years old. Informed consent has been obtained.
Key exclusion criteria	1. Previous adverse effects to Chinese medicine. 2. History of Qing-Dai use within a year. 3. Severe infection. 4. Patients using other drugs for chemotherapy induced oral mucositis. 5. Patients with cancer of oral cavity. 6. Patients with Sjogren's syndrome. 7. Patiens who have previous history of radiotherapy for head and neck. 8. Other conditions not suitable for this study.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kenro Hirata, Makoto Naganuma
Organization	Keio University School of Medicine
Division name	Gastroenterology and Hepatology
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	0333531211
Email	kenro916@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Kenro Hirata
Organization	Keio University School of Medicine
Division name	Gastroenterology and Hepatology
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	0333531211
Homepage URL
Email	kenro916@gmail.com

Sponsor
Institute	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	2017 Year 03 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	Completed
Date of protocol fixation	2017 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date	2017 Year 03 Month 21 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	2017 Year 02 Month 09 Day
Last modified on	2020 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029955