UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011801
Receipt number 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 03:04:57

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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

Obstetrics 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 or person

Institute

Tokyo Women's Medical University

Institute

Department

Personal name



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

Value
https://center6.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