UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028998 |
|---|---|
| Receipt number | R000032363 |
| Scientific Title | Prospective randomized controlled study to investigate the effect of Yokukansan on perioperative anxiety and pain. |
| Date of disclosure of the study information | 2017/09/10 |
| Last modified on | 2020/08/24 00:02:21 |
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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
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
moett@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata university Guraduate school of medical and dental sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032363
