UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034346 |
|---|---|
| Receipt number | 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 15:02:41 |
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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
| Obstetrics 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
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
kezaki@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital Obstetrics and gynecology South wing 6th floor 1 ward
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038958
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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