UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024271 |
|---|---|
| Receipt number | R000027945 |
| Scientific Title | Investigation of clinical usefulness of natural indigo ointment for patients with chemotherapy-induced oral mucositis |
| Date of disclosure of the study information | 2016/12/05 |
| Last modified on | 2020/05/21 14:48:16 |
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Basic information
Public title
Investigation of clinical usefulness of natural indigo ointment for patients with chemotherapy-induced oral mucositis
Acronym
Investigation of clinical usefulness of natural indigo ointment for patients with chemotherapy-induced oral mucositis
Scientific Title
Investigation of clinical usefulness of natural indigo ointment for patients with chemotherapy-induced oral mucositis
Scientific Title:Acronym
Investigation of clinical usefulness of natural indigo ointment for patients with chemotherapy-induced oral mucositis
Region
| Japan |
Condition
Condition
Chemotherapy-induced oral mucositis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Oral surgery |
Classification by malignancy
Malignancy
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 chemotherapy-induced oral mucositis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility
Key secondary outcomes
safety and clinical 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.
4. Patients who is receiving oral care.
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
19
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Hamamoto, Kenro Hirata |
Organization
Keio University School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
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
03-3353-1211
Homepage URL
kenro916@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2016 | Year | 12 | Month | 05 | 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
| 2016 | Year | 09 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 03 | Day |
Last modified on
| 2020 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027945
