UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035965
Receipt No. 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 2019/02/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ayuse@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki
University
Institute
Department

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
Email

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 20 Day
Last follow-up date
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
2019 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.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


Contact us.