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
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
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
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
