UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Sairei-To for postoperative pharyngeal pain and hoarseness
Title of the study (Brief title)	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	Toshiaki Minami
Organization	Osaka Medical College
Division name	Anesthesiology
Address	Daigaku-machi 2-7
TEL	0726-84-6361
Email	ane22@osaka-med.ac.jp

Public contact
Name of contact person	Komasawa Nobuyasu
Organization	Osaka Medical College
Division name	Anesthesiology
Address	2-7 Daigaku-machi
TEL	0726-84-6361
Homepage URL
Email	ane022@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	The perioperative stress or anxiety did not differe by preoperative Saireito administration.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024658