UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development study on kelp liquid therapy for dry mouth
Title of the study (Brief title)	Development study on kelp liquid therapy for dry mouth
Region	Japan

Condition
Condition	Dry mouth
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of kelp liquid therapy for dry mouth.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Salivary secretion
Key secondary outcomes	Oral sensory questionnaire

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	water gargle
Interventions/Control_2	kelp liquid gargle
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 diagnosed with dry mouth at Division of Oral Diagnosis, Tohoku University. (2)Patients aged tewnty or over at the regsitration who consent the participation of this study. (3)Patients accepted regardless of Gender or severity of dry mouth or medication.
Key exclusion criteria	(1)Patients with oral cancer. (2)Patients under the cancer therapy(Chemotherapy, radiotherapy, molecular target therapy, etc.) or with history of cancer. (3)Patients who received kelp liquid therapy. (4) Patients who have allergie or hypersensitivity to kelp or kelp broth. (5)Patients with contraindications of iodine (thyroid gland disease, phthisis, Dermatitis Herpetiformis Duhring, etc. ). (6)Patients with seviere herpetic, lichenious or ulcerative oral mucosal disease. (7)Patients who are difficult to give their informed consent in writing. (8)Patients who can not tolerate oral dryness test (measurement of whole salivary secretion, measurement of minor salivary secretion, mouth moisture retention measurement) (9)Patients who are consider to be inappropriate by the trial investigatiors.
Target sample size	220

Research contact person
Name of lead principal investigator	Shizuko, Satoh
Organization	Tohoku University
Division name	Division of Oral Diagnosis
Address	4-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-8390
Email	kuri-shu@dent.tohoku.ac.jp

Public contact
Name of contact person	Shizuko, Satoh
Organization	Tohoku University
Division name	Division of Oral Diagnosis
Address	4-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-8390
Homepage URL
Email	kuri-shu@dent.tohoku.ac.jp

Sponsor
Institute	Tohoku University Division of Oral Diagnosis
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Ajinomoto Co., Inc,.

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	2017 Year 04 Month 18 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 02 Month 22 Day
Anticipated trial start date	2017 Year 04 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 18 Day
Last modified on	2017 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031005