UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of Japanese traditional herbal medicine "Hangeshashinto"for radiation induced enteritis: Phase II trial
Title of the study (Brief title)	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	Taro Murai
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Radiology
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 Japan.
TEL	052-853-8276
Email	taro8864@yahoo.co.jp

Public contact
Name of contact person	Taro Murai
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Radiology
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 Japan.
TEL	052-853-8276
Homepage URL
Email	taro8864@yahoo.co.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024553