UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012304 |
|---|---|
| Receipt number | R000014389 |
| Scientific Title | Effect of pre-operative Hange-Shashin-To for postoperative nausea |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2014/09/23 20:11:15 |
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Basic information
Public title
Effect of pre-operative Hange-Shashin-To for postoperative nausea
Acronym
Effect of Hange-Shashin-To for PONV
Scientific Title
Effect of pre-operative Hange-Shashin-To for postoperative nausea
Scientific Title:Acronym
Effect of Hange-Shashin-To for PONV
Region
| Japan |
Condition
Condition
Patients who undergo general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Hange-Shashin-To for PONV.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of Hange-Shashin-To for PONV.
Key secondary outcomes
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
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Hange-Shashin-To
Interventions/Control_2
Non Administration of Hange-Shashin-To
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
laparoscopic surgery
Key exclusion criteria
Gastroenterology operation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayumu Kuwamura |
Organization
Daiichi Towakai Hospital
Division name
Dept of Anesthesiology
Zip code
Address
Takatsuki city, Miyanocho 2-17
TEL
0726711008
ayumukuwamura@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kuwamura Ayumu |
Organization
Daiichi Towakai Hospital
Division name
Dept of Anesthesiology
Zip code
Address
Takatsuki city, Miyanocho 2-17
TEL
0726711008
Homepage URL
ayumukuwamura@gmail.com
Sponsor or person
Institute
Daiichi Towakai Hospital
Institute
Department
Personal name
Funding Source
Organization
Daiichi Towakai Hospital
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
Address
Tel
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
| 2014 | Year | 01 | 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
Results
HST was not effective for alleviation of nausea but effective for suppression of pharyngeal pain.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 18 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 22 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 24 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 15 | Day |
Last modified on
| 2014 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014389
