UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011692 |
|---|---|
| Receipt number | R000013670 |
| Scientific Title | The usefullness of the Chinese medicine tablet to the oral mucositis resulting from a cancer chemotherapy and radiotherapy, or a simultaneous combined therapy |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2024/03/18 15:19:25 |
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Basic information
Public title
The usefullness of the Chinese medicine tablet to the oral mucositis resulting from a cancer chemotherapy and radiotherapy, or a simultaneous combined therapy
Acronym
The usefullness of the Chinese medicine tablet to the oral mucositis resulting from a cancer chemotherapy and radiotherapy, or a simultaneous combined therapy
Scientific Title
The usefullness of the Chinese medicine tablet to the oral mucositis resulting from a cancer chemotherapy and radiotherapy, or a simultaneous combined therapy
Scientific Title:Acronym
The usefullness of the Chinese medicine tablet to the oral mucositis resulting from a cancer chemotherapy and radiotherapy, or a simultaneous combined therapy
Region
| Japan |
Condition
Condition
Oral Mucotisis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefullness of the Chinese medicine tablet to the oral mucositis resulting from a cancer chemotherapy and radiotherapy, or a simultaneous combined therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Grade of oral mucotisis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A:administration group
Interventions/Control_2
B:non-administration group
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Carcinoma
2)chemotherapy and radiotherapy, or a simultaneous combined therapy
3)Performance Status(P.S.) under 2
5)Aged 20 to 80 years old
Key exclusion criteria
5)infection
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Momota |
Organization
The Tokushima University Hospital
Division name
Oral Medicine
Zip code
7708504
Address
2-50-1, Kuramoto-cho,Tokushima-shi,Tokushima
TEL
088-633-7372
takano@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Momota |
Organization
The Tokushima University Hospital
Division name
Oral Medicine
Zip code
7708504
Address
2-50-1, Kuramoto-cho,Tokushima-shi,Tokushima
TEL
088-633-7372
Homepage URL
momota@tokushima-u.ac.jp
Sponsor or person
Institute
The Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokushima graduate school
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
The University of Tokushima graduate school
Address
3-18-15, Kuramoto-cho,Tokushima-shi,Tokushima
Tel
088-633-7372
momota@tokushima-u.ac.jp
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
| 2014 | Year | 01 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 17 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 17 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 17 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 17 | Day |
Other
Other related information
Certain types of herbal medicines have been found to suppress inflammation in vitro. However, due to the significant impact of mechanical stimulation and other factors, it has been determined that they are unlikely to be effective in clinically reducing the severity of oral mucositis caused by chemotherapy and radiation therapy.
Management information
Registered date
| 2013 | Year | 09 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013670
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
