UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of cases administrated Daikenchuto suppositories for paralytic ileus in terminally ill cancer patients.
Title of the study (Brief title)	Effect of Daikenchuto suppositories for paralytic ileus.
Region	Japan

Condition
Condition	We have prepared Daikenchuto suppositories to administrate for 60 patients who have ileus with nausea or vomiting.
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We reconfirmed that administration of Daikenchuto suppositories was effective in paralytic ileus and examined by comparing group of oral intake resumes and non-oral intake.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Palliative Prognostic Index(PPI) on admission
Key secondary outcomes	Improvement rates of nausea, vomiting, abdominal pain, oral intake resumes and hospitalization, combination with Octreotide, complication of peritoneal dissemination.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	terminally ill cancer patients with paralytic ileus.
Key exclusion criteria	1) A patiet with stenosis or bleeding of rectum or recatal cancer 2) A patient who rejectes the administration.
Target sample size	60

Research contact person
Name of lead principal investigator	Toshiyuki Takeshige
Organization	Fukushima Medical University, Aizu Medical Center
Division name	Palliative Care
Address	21-2 Maeda,Yazawa,Kawahigashi-machi,Fukushima
TEL	0242-75-2100
Email	takesige1@msn.com

Public contact
Name of contact person	Toshiyuki Takeshige
Organization	Fukushima Medical University, Aizu Medical Center
Division name	Palliative Care
Address	21-2 Maeda,Yazawa,Kawahigashi-machi,Fukushima
TEL	0242-75-2100
Homepage URL
Email	takesige1@msn.com

Sponsor
Institute	Fukushima Medical University, Aizu Medical Center
Institute
Department

Funding Source
Organization	Fukushima Medical University, Aizu Medical Center
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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	2017 Year 01 Month 16 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 12 Month 01 Day
Anticipated trial start date	2017 Year 01 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	With regard to PPI<6 , significant differences appear in improvement rates of paralytic ileus (96%). According to the above results, we assessed Daikenchuto suppositories were extremely effective in PPI<6 and oral intake resumes of paralytic ileus.
Other related information	nothing in particular.

Management information
Registered date	2017 Year 01 Month 15 Day
Last modified on	2017 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029551