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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011801
Receipt No. R000013731
Scientific Title Is Goreisan effective for preventing postoperative nausea and vomiting?-The randomized controlled trial-
Date of disclosure of the study information 2013/11/30
Last modified on 2018/09/23

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Basic information
Public title Is Goreisan effective for preventing postoperative nausea and vomiting?-The randomized controlled trial-
Acronym Is Goreisan effective for preventing postoperative nausea and vomiting?
Scientific Title Is Goreisan effective for preventing postoperative nausea and vomiting?-The randomized controlled trial-
Scientific Title:Acronym Is Goreisan effective for preventing postoperative nausea and vomiting?
Region
Japan

Condition
Condition Postoperative Nausea and Vomiting
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of Goreisan for postoperative nausea and vomiting with gynecological patients after general anesthesia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The severity of postoperative nausea and vomiting evaluated by objective scaling number.

The total amount of antiemetic drug dosage used for postoperative nausea and vomiting.
Key secondary outcomes The severity of postoperative pain evaluated by objective scaling number.

The amount of analgesic drug dosage needed to control patients pain.

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 a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine Food
Interventions/Control_1 Before the surgical operation is completed, we administer Goreisan through a gastric tube.
Interventions/Control_2 Before the surgical operation is completed, we administer normal saline through a gastric tube.
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
50 years-old >=
Gender Female
Key inclusion criteria Gynecological elective surgery patients with general anesthesia
Key exclusion criteria Severe preoperative complications
Severe postoperative complications
History of the Chinese herb usage
History of the chemotherapy for malignnant deseases
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Ozaki
Organization Tokyo Women's Medical University
Division name Anesthesiology
Zip code
Address Tokyo, Japan 162-8666
TEL 03-3353-8111
Email mozaki@anes.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Kume
Organization Tokyo Women's Medical University
Division name Anesthesiology
Zip code
Address Tokyo, Japan 162-8666
TEL 03-3353-8111
Homepage URL
Email kkume@anes.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Tokyo Women's Medical University
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 東京女子医科大学病院

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 01 Day
Last follow-up date
2018 Year 09 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 09 Month 22 Day

Other
Other related information

Management information
Registered date
2013 Year 09 Month 18 Day
Last modified on
2018 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013731

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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