UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017390 |
|---|---|
| Receipt number | R000020110 |
| Scientific Title | Effectiveness and safety examination of the JPS Hangekobokuto extract granule (for composition) for dysphagia and the after cardiac surgery |
| Date of disclosure of the study information | 2015/05/02 |
| Last modified on | 2020/05/28 15:45:17 |
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Basic information
Public title
Effectiveness and safety examination of the JPS Hangekobokuto extract granule (for composition) for dysphagia and the after cardiac surgery
Acronym
Hangekobokuto study
Scientific Title
Effectiveness and safety examination of the JPS Hangekobokuto extract granule (for composition) for dysphagia and the after cardiac surgery
Scientific Title:Acronym
Hangekobokuto study
Region
| Japan |
Condition
Condition
Patient after the cardiac operation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the administration of hangekobokuto for 2 weeks after cardiac surgery decreases the incidence of swallowing disorder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Swallowing reflex test
Key secondary outcomes
coughing reflection test
Substance P quantitative examination in saliva
Aspiration pneumonia incidence rate
Amount of antibiotic
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
lactose(placebo) 7.5g/day 14days
Interventions/Control_2
JPS hange-kobokuto extract granule(for composition) 7.5g/day 14days
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
Patients who will undergo cardiac surgery (including a sternal midline incision procedure) as a scheduled surgery in the Department of Cardiovascular Surgery at our hospital.
1) Men and women over 20 years old who can orally ingest hangekobokuto
2) Patients who received an explanation of the objective and content of this research, and in whom voluntary consent could be obtained
Key exclusion criteria
1) Patients undergoing developing drug administration or patients scheduled for developing drug administration
2) Patients who are pregnant or who want to become pregnant during the study observation period, as well as patients who are lactating
3) Patients who are taking or are scheduled to take other kampo medicines
4) Patients with Parkinson's disease and cerebral infarction, and those who are prone to develop aspiration pneumonitis.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kawago |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Cardiovascular surgery
Zip code
193-0998
Address
1163, Tachimachi, Hachioji-shi, Tokyo
TEL
042-665-5611
kkawago@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Kawago |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Cardiovascular surgery
Zip code
193-0998
Address
1163, Tachimachi, Hachioji-shi, Tokyo
TEL
042-665-5611
Homepage URL
kkawago@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hachioji Medical Center Cardiovascular surgery
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University Hachioji Medical Center Cardiovascular surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Hachioji Medical Center IRB
Address
1163, Tachimachi, Hachioji-shi, Tokyo
Tel
042-665-5611
h-somu@tokyo-med.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
東京医科大学八王子医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
https://doi.org/10.5761/atcs.oa.19-00128
Publication of results
Unpublished
Result
URL related to results and publications
https://doi.org/10.5761/atcs.oa.19-00128
Number of participants that the trial has enrolled
34
Results
The rate of subjects with postoperative aspiration pneumonia was significantly lower in the HKT group than in the placebo group (p = 0.017).
Results date posted
| 2020 | Year | 05 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Consecutive patients undergoing cardiovascular surgery at the Department of Cardiovascular Surgery of Tokyo Medical University Hachioji Medical Center between August 2014 and August 2015
Participant flow
All patients provided written informed consent.
Adverse events
n.p
Outcome measures
The primary endpoint was prevention of postoperative aspiration pneumonia.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 02 | Day |
Last modified on
| 2020 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020110
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/06/25 | 半夏厚朴湯試験デザインP.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
