UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022074 |
|---|---|
| Receipt number | R000025454 |
| Scientific Title | Effects of tongue scraping on digestion and oral health-related QOL from the Ayurvedic perspective: a randomized, wait-list controlled study |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2017/04/27 09:48:24 |
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Basic information
Public title
Effects of tongue scraping on digestion and oral health-related QOL from the Ayurvedic perspective: a randomized, wait-list controlled study
Acronym
Effect of tongue scraping on digestion and oral health-related QOL
Scientific Title
Effects of tongue scraping on digestion and oral health-related QOL from the Ayurvedic perspective: a randomized, wait-list controlled study
Scientific Title:Acronym
Effect of tongue scraping on digestion and oral health-related QOL
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of tongue scraping on digestion and oral health-related QOL from the Ayurvedic perspective.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Ama (unmetabolized waste products) level (Ayurvedic assessment)
Key secondary outcomes
1. Oral health-related QOL
2. Tongue coating level
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Self tongue scraping with a tongue scraper, once in a day in the morning, for 4 weeks
Interventions/Control_2
Wait-list
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy individuals though complaining of heaviness of the body, sleepiness in daytime, loss of appetite, etc.
Key exclusion criteria
1. Any underlying disease
2. Pregnant women
3. Undergoing oral treatment or planning to undergo oral treatment during study period
4. Taking medicines or supplements which may have effects on digestive system
5. Took antibiotic therapy in the previous 1 month
6. Already practicing tongue scraping
7. Any abnormality in the toungue
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiko Tokinobu |
Organization
Okayama University
Division name
Graduate School of Environmental and Life Science
Zip code
Address
3-1-1, Tsushima-naka, Kita-ku, Okayama-shi, Okayama
TEL
086-251-8926
tokichin@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Tokinobu |
Organization
Okayama University
Division name
Graduate School of Environmental and Life Science
Zip code
Address
3-1-1, Tsushima-naka, Kita-ku, Okayama-shi, Okayama
TEL
086-251-8926
Homepage URL
tokichin@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Foundation for Total Health Promotion
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
岡山大学環境生命科学研究科（岡山県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 26 | Day |
Last modified on
| 2017 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025454
