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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026072
Receipt No. R000029955
Scientific Title Investigation of clinical usefulness of natural indigo ointment for patients with inflammatory bowel disease
Date of disclosure of the study information 2017/03/01
Last modified on 2019/03/08

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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 30

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
2019 Year 03 Month 08 Day


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

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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