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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006756
Receipt No. R000007988
Scientific Title The treatment of xerostomia by autogenic training
Date of disclosure of the study information 2011/12/10
Last modified on 2011/11/21

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Basic information
Public title The treatment of xerostomia by autogenic training
Acronym autogenic training for xerostomia
Scientific Title The treatment of xerostomia by autogenic training
Scientific Title:Acronym autogenic training for xerostomia
Region
Japan

Condition
Condition xerostomia
Classification by specialty
Oto-rhino-laryngology Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The benefit of autogenic training to xerostomia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes salivary flow for 15min
Key secondary outcomes psychological examinations (SDS,STAI),
Blood examination

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 autogenic training
Interventions/Control_2 cevimeline hydrochloride hydrate
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
90 years-old >=
Gender Male and Female
Key inclusion criteria xerostomia
Key exclusion criteria shegren syndrome, the post surgical stage of salivary gland extraction. irradiation, Drug (anti choligenic drug, antidepressant)
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumiyuki Goto
Organization Hino Municipal Hospital
Division name otolaryngolgoy
Zip code
Address 4-3-1 Tamadaira HInoshi
TEL 042-581-2677
Email

Public contact
Name of contact person
1st name
Middle name
Last name Fumiyuki goto
Organization Hino Municial Hospital
Division name otolarynoglogy
Zip code
Address 4-3-1 Tamadaira HInoshi
TEL 042-581-2677
Homepage URL
Email

Sponsor
Institute Hino Municial Hospital
Institute
Department

Funding Source
Organization Self funding
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
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
2011 Year 12 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
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
2011 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 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
2011 Year 11 Month 21 Day
Last modified on
2011 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007988

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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