UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022110 |
|---|---|
| Receipt number | R000024553 |
| Scientific Title | Effectiveness of Japanese traditional herbal medicine "Hangeshashinto"for radiation induced enteritis: Phase II trial |
| Date of disclosure of the study information | 2016/04/27 |
| Last modified on | 2017/10/30 10:00:46 |
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Basic information
Public title
Effectiveness of Japanese traditional herbal medicine "Hangeshashinto"for radiation induced enteritis: Phase II trial
Acronym
Hangeshashinto for radiation induced enteritis
Scientific Title
Effectiveness of Japanese traditional herbal medicine "Hangeshashinto"for radiation induced enteritis: Phase II trial
Scientific Title:Acronym
Hangeshashinto for radiation induced enteritis
Region
| Japan |
Condition
Condition
Effectiveness of Japanese traditional herbal medicine "Hangeshashinto"for radiation induced enteritis: Phase II trial
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of Japanese traditional herbal medicine "Hangeshashinto" for patients with acute radiation enteritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Efficacy 1 week after administration
Key secondary outcomes
1) Efficacy 2 months after administration.
2) FACT-G score 1 week and 2 months after administration.
3) Toxicity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Effectiveness of Japanese traditional herbal medicine "Hangeshashinto"
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) Increase of number of evacuation
2) Pelvic irradiation (> 40 Gy)
3) Age > 20
4) Karnofsky Performance Scale Index > 70
Key exclusion criteria
1) Pantients with aldsteronism
2) Serum K < 3.5 mEq/l
3) Pregnant patients
4) Patients with allergy to herbal medicine
5) Patients with artificial anus
6) Patients with clinically confirmed brain metastases
7) Patients with psychiatric disease
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Murai |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Radiology
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 Japan.
TEL
052-853-8276
taro8864@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Murai |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Radiology
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 Japan.
TEL
052-853-8276
Homepage URL
taro8864@yahoo.co.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Research Foundation for Oriental Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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 | 04 | Month | 27 | 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
| 2015 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 27 | Day |
Last modified on
| 2017 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024553
