UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the pain relief effect of Goreisan for glossodynia with dry mouth 2
Acronym	Examination of the pain relief effect of Goreisan for glossodynia 2
Scientific Title	Examination of the pain relief effect of Goreisan for glossodynia with dry mouth 2
Scientific Title:Acronym	Examination of the pain relief effect of Goreisan for glossodynia 2
Region	Japan

Condition
Condition	Glossodynia
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the degree of pain reduction effect of Goreisan administration in patients who are diagnosed with glossodynia with dry mouth and are undergoing treatment in the dental anesthesiology department.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Self-filled pain scale (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	1) Patients who have been diagnosed with glossodynia with dry mouth and are undergoing treatment at the oral pain liaison outpatient department of Nagasaki University Hospital 2)Age: Adult patients older than 20 years old when obtaining consent 3)Gender: Any 4) Hospitalization / Outpatient: Outpatient only 5)Patients who have received sufficient explanation for participation in this study, and who have received sufficient written consent from the patient himself / herself with sufficient understanding
Key exclusion criteria	1) Patients taking Chinese medicine other than Gojosan 2)Patients with severe hypertension whose diastolic blood pressure is 120mmHg or more 3) Patients with severe liver and renal dysfunction 4) Patients with allergies and other drug sensitivity 5) Pregnant women and patients who may be pregnant or breastfeeding 6) Other patients who are deemed inappropriate by the research director
Target sample size	15

Research contact person
Name of lead principal investigator	1st name TAKAO Middle name Last name AYUSE
Organization	nagasaki university
Division name	Deantal Anesthesia
Zip code	8528588
Address	1-7-1 Sakamoto Nagasaki
TEL	0958197713
Email	ayuse@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name TAKAO Middle name Last name AYUSE
Organization	Nagasaki University Hospital
Division name	Deantal Anesthesia
Zip code	8528588
Address	1-7-1 Sakamoto Nagasaki
TEL	0958197713
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	Nagasaki University Hospital Clinical Research Ethics Committee
Address	1-7-1 Sakamoto Nagasaki
Tel	0958197713
Email	0958197713

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 08 Month 16 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	Delay expected
Results Delay Reason	delay in analysis
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	2019 Year 08 Month 15 Day
Date of IRB	2019 Year 08 Month 20 Day
Anticipated trial start date	2019 Year 09 Month 01 Day
Last follow-up date	2019 Year 12 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 08 Month 16 Day
Last modified on	2021 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043002