UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035965 |
|---|---|
| Receipt number | R000040963 |
| Scientific Title | The effects of Goreisan on pain perception in Glossodynia associate with dry mouth |
| Date of disclosure of the study information | 2019/02/21 |
| Last modified on | 2021/01/28 09:37:11 |
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Basic information
Public title
The effects of Goreisan on pain perception in Glossodynia associate with dry mouth
Acronym
The effects of Goreisan on pain perception in Glossodynia
Scientific Title
The effects of Goreisan on pain perception in Glossodynia associate with dry mouth
Scientific Title:Acronym
The effects of Goreisan on pain perception in Glossodynia
Region
| Japan |
Condition
Condition
Glossodynia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The narrative objective is to test the effects of Goreisan on peinperception in Glossodynia associated with dry mouth.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain evaluated by VAS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Goreisan
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with diagnosis of Glossodynia with dry mouth
over 20 years old
both gender
outpatients
patients with IC
Key exclusion criteria
patients medicated with other Kampo drug
patients with hypertension over diastolic pressure over 120mmHg
severe liver and /or renal disease
allergy for drug
pregnant women
patients attending other clinical study within 4 months
patients should avoided based on researcher's evaluation
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAKAO AYUSE |
Organization
nagasaki university
Division name
Dental Anesthesia
Zip code
Address
1-7-1 Sakamoto Nagasaki
TEL
0958197713
ayuse@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TAKAO AYUSE |
Organization
Nagasaki University Hospital
Division name
Dental Anesthesia
Zip code
Address
1-7-1 Sakamoto Nagasaki
TEL
0958197714
Homepage URL
ayuse@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki
University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
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
| 2019 | Year | 02 | Month | 21 | Day |
Related information
URL releasing protocol
DOI 10.1007/s13596-020-00441-x
Publication of results
Published
Result
URL related to results and publications
DOI 10.1007/s13596-020-00441-x
Number of participants that the trial has enrolled
14
Results
The administration of Goreisan for two weeks lead to significant reduction of pain perception based on the evaluation of Self-filled pain scale (VAS) and tongue perception test (QST). There is correlation between barometric pressure and self-filled VAS scale. This fact might indicate that Goreisan would be the alternative treatment for glossodynia patients. Goreisan would be a successful alternative treatment modality for glossodynia patients.
Results date posted
| 2021 | Year | 01 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
no change in baseline characteristics
Participant flow
no change in participant flwo
Adverse events
NONE
Outcome measures
no change on out ocome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 21 | Day |
Last modified on
| 2021 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040963
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/02/21 | 1-24-2委員会後修正 舌痛症_五苓散 実施計画書20190219新規申請.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
