UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of tongue scraping on digestion and oral health-related QOL from the Ayurvedic perspective: a randomized, wait-list controlled study
Title of the study (Brief title)	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	Akiko Tokinobu
Organization	Okayama University
Division name	Graduate School of Environmental and Life Science
Address	3-1-1, Tsushima-naka, Kita-ku, Okayama-shi, Okayama
TEL	086-251-8926
Email	tokichin@okayama-u.ac.jp

Public contact
Name of contact person	Akiko Tokinobu
Organization	Okayama University
Division name	Graduate School of Environmental and Life Science
Address	3-1-1, Tsushima-naka, Kita-ku, Okayama-shi, Okayama
TEL	086-251-8926
Homepage URL
Email	tokichin@okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025454