UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037705
Receipt number R000043002
Scientific Title Examination of the pain relief effect of Goreisan for glossodynia with dry mouth 2
Date of disclosure of the study information 2019/08/16
Last modified on 2021/02/15 09:30:45

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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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043002


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name