UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022656
Receipt number R000024658
Scientific Title Evaluation of Sairei-To for postoperative pharyngeal pain and hoarseness
Date of disclosure of the study information 2016/06/10
Last modified on 2017/08/13 09:18:34

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Basic information

Public title

Evaluation of Sairei-To for postoperative pharyngeal pain and hoarseness

Acronym

Sairei-To for postoperative pharyngeal pain and hoarseness

Scientific Title

Evaluation of Sairei-To for postoperative pharyngeal pain and hoarseness

Scientific Title:Acronym

Sairei-To for postoperative pharyngeal pain and hoarseness

Region

Japan


Condition

Condition

Patient who undergo general anesthesia with tracheal intubation

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of postoperative pharyngeal pain and hoarseness

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Postoperative hoarseness and pharyngeal pain

Key secondary outcomes

Postoperative nausea and vomit
Perioperative anxiety


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



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Take 2 times of 2.5 g Sairei-To before sleep and the morning

Interventions/Control_2

Do not take Sairei-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

75 years-old >

Gender

Female

Key inclusion criteria

Patient who undergo general anesthesia with tracheal intubation

Key exclusion criteria

Patient who take Kampo or analgesics

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiaki Minami

Organization

Osaka Medical College

Division name

Anesthesiology

Zip code


Address

Daigaku-machi 2-7

TEL

0726-84-6361

Email

ane22@osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Komasawa Nobuyasu

Organization

Osaka Medical College

Division name

Anesthesiology

Zip code


Address

2-7 Daigaku-machi

TEL

0726-84-6361

Homepage URL


Email

ane022@osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College

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


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

2016 Year 06 Month 10 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

The perioperative stress or anxiety did not differe by preoperative Saireito administration.

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

2016 Year 06 Month 08 Day

Date of IRB


Anticipated trial start date

2016 Year 06 Month 12 Day

Last follow-up date

2017 Year 08 Month 12 Day

Date of closure to data entry

2017 Year 08 Month 14 Day

Date trial data considered complete

2017 Year 08 Month 15 Day

Date analysis concluded

2017 Year 08 Month 17 Day


Other

Other related information

There was no significant difference between the groups.


Management information

Registered date

2016 Year 06 Month 08 Day

Last modified on

2017 Year 08 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024658


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name