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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018381
Receipt No. R000021283
Scientific Title The effectiveness of prophylactic antiemetics 'syouhangekabukuryouto' on postoperative nausea and vomiting patients
Date of disclosure of the study information 2015/08/01
Last modified on 2017/04/16

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Basic information
Public title The effectiveness of prophylactic antiemetics 'syouhangekabukuryouto' on postoperative nausea and vomiting patients
Acronym The effectiveness of prophylactic antiemetics 'syouhangekabukuryouto' on postoperative nausea and vomiting patients
Scientific Title The effectiveness of prophylactic antiemetics 'syouhangekabukuryouto' on postoperative nausea and vomiting patients
Scientific Title:Acronym The effectiveness of prophylactic antiemetics 'syouhangekabukuryouto' on postoperative nausea and vomiting patients
Region
Japan

Condition
Condition women who will receive laparoscopic gynecologic surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether Shohangekabukuryouto prevent PONV over 24 hours after laparoscopic gynecologic surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To determine whether Shohangekabukuryouto prevent PONV over 24 hours after laparoscopic gynecologic surgery
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Syouhangekabukuryouto 3g
Interventions/Control_2 lactose 3g
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
60 years-old >=
Gender Female
Key inclusion criteria patients over 20 years oldwho will receive laparoscopic gynecologic surgery under general anesthesia at our institution
Key exclusion criteria Patients who will receive an emergency operation
Patients who have allergic reaction to drugs
Patients who used prophylactic antiemetic drugs whithin 24 hours before operation
Patients who used analgetic drugs whithin 24 hours before operation
Patients who have used Chinese harb
Patients who is lactose intolerant
Patients who we couldn't get a consent form
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makito Kanako
Organization Saiseikai central hospital
Division name Department of Anesthesiology
Zip code
Address 1-4-17 mita minato-ku Tokyo Japan
TEL 03-3451-8211
Email canakana87@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name makito kanako
Organization Saiseikai Central Hospital
Division name Department of Anesthesiology
Zip code
Address 1-4-17 mita minato-ku Tokyo Japan
TEL 03-3451-8211
Homepage URL
Email canakana87@gmail.com

Sponsor
Institute Saiseikai Central Hospital
Institute
Department

Funding Source
Organization Saiseikai Central Hospital Anesthesiology
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
Email

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
2015 Year 08 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
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
2015 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 15 Day
Last follow-up date
2016 Year 11 Month 03 Day
Date of closure to data entry
Date trial data considered complete
2016 Year 11 Month 03 Day
Date analysis concluded
2016 Year 11 Month 03 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 22 Day
Last modified on
2017 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021283

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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