UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000034346
Receipt No. R000038958
Scientific Title Examination on more effective method of oral administration of Daikenchutou
Date of disclosure of the study information 2018/10/01
Last modified on 2019/10/23 (Ver. 6)

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Basic information
Public title Examination on more effective method of oral administration of Daikenchutou
Acronym Effective method of oral administration of Daikenchutou
Scientific Title Examination on more effective method of oral administration of Daikenchutou
Scientific Title:Acronym Effective method of oral administration of Daikenchutou
Region
Japan

Condition
Condition Gynecological disorders in general
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We derive a more effective method of oral administration of Daikenchutsu in dissolving in hot water and oral administration with water or lukewarm water as granules.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Remaining amount at the time of medication
Key secondary outcomes Abdominal symptoms (abdominal pain, nausea), incidence of ileus

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Daikenchutsu is dissolved in 100 mL of plain hot water, and the drug is administered orally for 10 days
Interventions/Control_2 Daikenchuto is taken as granules in water or lukewarm water for 10 days
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 Female
Key inclusion criteria Obstetrics and gynecology diseases Malignant tumor abdominal surgery case
Key exclusion criteria Patients with a history of interstitial pneumonia
Patients with mental illness or cognitive dysfunction
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Shinichiro
Middle name
Last name Yamaguchi
Organization Kyushu University Hospital Obstetrics and gynecology
Division name South wing 6th floor 1 ward
Zip code 812-8582
Address 3-1-1,Maedashi,Higashi-ku,Fukuoka-shi,Fukuoka,JAPAN
TEL 092-642-5403
Email ysimicir@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Keiko
Middle name
Last name Ezaki
Organization Kyushu University Hospital
Division name Nursing department
Zip code 812-8582
Address 3-1-1,Maedashi,Higashi-ku,Fukuoka-shi,Fukuoka,JAPAN
TEL 092-642-5403
Homepage URL
Email kezaki@med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital Obstetrics and gynecology South wing 6th floor 1 ward
Institute
Department

Funding Source
Organization Kyushu University Hospital Obstetrics and gynecology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyushu University Hospital Obstetrics and gynecology
Address 3-1-1,Maedashi,Higashi-ku,Fukuoka-shi,Fukuoka,JAPAN
Tel 092-642-5403
Email kezaki@med.kyushu-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 九州大学病院（福岡県）

Other administrative information
Date of disclosure of the study information
2018 Year 10 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 30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Cases of laparotomy for obstetrics and gynecology malignancy over 20 years old
Participant flow 
Randomized controlled trial
2pakets of Daikenchuto (TJ-100) was dissolved and administered in warm water (dissolved group)
2pakets of Daikenchuto (TJ-100) was take  as granules (granule group)
Adverse events 
No adverse event
Outcome measures 
Primary endpoint:
Amount of leftovers of Daikenchuyu (TJ-100)
Visual Analogue Scale with abdominal pain,nausea and insomnia
Patient questionnaire
Secondary endpoint:
Ileus incidence
First defecation after surgery
Pantol formulation administration
Plan to share IPD No individual case data sharing plan
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
2018 Year 09 Month 25 Day
Anticipated trial start date
2018 Year 10 Month 05 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 10 Month 01 Day
Last modified on
2019 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038958