UMIN-CTR Clinical Trial

Basic information
Public title	Prospective randomized controlled study to investigate the effect of Yokukansan on perioperative anxiety and pain.
Acronym	Prospective randomized controlled study to investigate the effect of Yokukansan on perioperative anxiety and pain.
Scientific Title	Prospective randomized controlled study to investigate the effect of Yokukansan on perioperative anxiety and pain.
Scientific Title:Acronym	Prospective randomized controlled study to investigate the effect of Yokukansan on perioperative anxiety and pain.
Region	Japan

Condition
Condition	breast cancer patients
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of yokukansan on anxiety and pain in perioperative patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	subjective evaluation items: HADS( Hospital anxiety and depression scale) objective evaluation items: salivaly amylase activity
Key secondary outcomes	STAI(State Trait Anxiety Inventory) QoR (quality of recovery) score VAS score of pain

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Yokukansan group take 2.5 g of yokukansan before asleep on the previous day and 2hr before the surgery on the operation day.
Interventions/Control_2	Control group take nothing.
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 who undergo total breast excision and sentinel lymph node biopsy, or breast partial resection and sentinel lymph node biopsy
Key exclusion criteria	patients who -disagree to participate in this study -ASA-physical status =/>4 -Body Mass Index=/>30kg/m2 -has difficulty for communication (eg. patient suffered from dementia, has mental retardation, can not understand Japanese) -has allergy for the drugs that will use in this study -is suffering from pain -is received anxiolytic or antipsychotic medication. -is received analgesics or opioid medication -whom the examiner assume inadequate to participate in this study
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Baba
Organization	Niigata university Guraduate school of medical and dental sciences
Division name	division of Anesthesiology
Zip code	951-8520
Address	757-1, Asahimachi-dori, Chuo-ku, Niigata
TEL	025-227-2328
Email	baba@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Moegi Middle name Last name Tanaka
Organization	Niigata university Guraduate school of medical and dental sciences
Division name	division of Anesthesiology
Zip code	951-8520
Address	757-1, Asahimachi-dori, Chuo-ku, Niigata
TEL	025-227-2328
Homepage URL
Email	moett@med.niigata-u.ac.jp

Sponsor
Institute	Niigata university Guraduate school of medical and dental sciences
Institute
Department

Funding Source
Organization	Niigata university Guraduate school of medical and dental sciences
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Niigata university Guraduate school of medical and dental sciences
Address	757-1, Asahimachi-dori, Chuo-ku, Niigata
Tel	025-227-2328
Email	baba@med.niigata-u.ac.jp

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	2017 Year 09 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	80
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	2017 Year 07 Month 01 Day
Date of IRB	2017 Year 07 Month 10 Day
Anticipated trial start date	2017 Year 08 Month 17 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry	2020 Year 06 Month 01 Day
Date trial data considered complete	2020 Year 06 Month 01 Day
Date analysis concluded	2020 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date	2017 Year 09 Month 05 Day
Last modified on	2020 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032363