UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Deveropment of Swallowing function improvement agents with ginger
Title of the study (Brief title)	Deveropment of Swallowing function improvement agents with ginger
Region	Japan

Condition
Condition	none
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Dysphagia, likely to occur, such as care the elderly, and the swallowing reflex to swallow food, cough reflex to eliminate coughing when entering into any chance trachea occurs is failure. These two reflections are in a normal state is controlled by the substance P (SP) being released from the oral cavity and bronchial mucosa. Reduced secretion of this SP is said to be the cause of dysphagia. As the cause, due to the fact that dopamine is no longer synthesized in the basal ganglia with aging and brain vascular disorder. Dysphagia, consisting of saliva and food of bacteria and Pepper in the oral cavity and the cause of the aspiration into the trachea. By repeating many times the aspiration, finally there is a risk that lead to aspiration pneumonia, 80% of elderly pneumonia is to be an aspiration pneumonia. This time, for the purpose of development of effective swallowing function improvement goods, carry out the clinical assessment on the review and swallowing function of the impact of pungent stimulation on the SP concentration in saliva.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Saliva substance P blood substance P
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food Other
Interventions/Control_1	Ginger (active ingredient: 6-gingerol, 6-ginger-ol) an appropriate amount containing the oral formulation (orally disintegrating tablets, film agents, oral spray) to prepare, for use in clinical trials that were performed a pharmaceutical study. The period of administration, and a single and long-term (28 days). Ginger blended formulation before and after administration, the subject is the collection of saliva and blood was carried out, the SP concentration of saliva and blood is said to control the cough reflection is measured by ELISA method. The day that saliva and blood sampling, subjects fasted until collecting the end, the moisture does not limit. In the case of long-term administration, not specifically taken into account. In addition, the grouping of subjects and long-term administration is followed by a single dose for each dosage form of ginger blended formulation, and sequentially distributed. Further, in the same subject, to change the dosage forms and duration may perform multiple administrations.
Interventions/Control_2	Ginger (active ingredient: 6-gingerol, 6-ginger-ol) an appropriate amount containing percutaneous absorption preparation (plaster, pack, ointments, creams ) to prepare, for use in clinical trials that were performed a pharmaceutical study. The period of administration, and a single and long-term (28 days). Ginger blended formulation before and after administration, the subject is the collection of saliva and blood was carried out, the SP concentration of saliva and blood is said to control the cough reflection is measured by ELISA method. The day that saliva and blood sampling, subjects fasted until collecting the end, the moisture does not limit. In the case of long-term administration, not specifically taken into account. In addition, the grouping of subjects and long-term administration is followed by a single dose for each dosage form of ginger blended formulation, and sequentially distributed. Further, in the same subject, to change the dosage forms and duration may perform multiple administrations.
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	1.healthy adults (20 to 64 years old) 2. healthy elderly (65 years of age or older) 3.The elderly that have lowering of swallowing function due to aging (65 years of age or older)
Key exclusion criteria	1.Minors 2.Inadequate adult's judgment ability 3.Subjects who are receiving medical attention have a brain vascular disorder as underlying disease is excluded
Target sample size	360

Research contact person
Name of lead principal investigator	Mitsuhiko Miyamura
Organization	Kochi medical school hospital
Division name	Pharmacy
Address	185-1, kohasu, oko, nankoku, kochi, Japan
TEL	088-880-2549
Email	im55@kochi-u.ac.jp

Public contact
Name of contact person	Kohei Jobu
Organization	Kochi medical school hospital
Division name	Pharmacy
Address	185-1, kohasu, oko, nankoku, kochi, Japan
TEL	088-880-2549
Homepage URL
Email	jm-kouheij@kochi-u.ac.jp

Sponsor
Institute	Kochi medical school hospital
Institute
Department

Funding Source
Organization	Ministry of education, culture, sports, science and techonology Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
Name of secondary funｄer(s)	none

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	2016 Year 09 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 02 Month 14 Day
Anticipated trial start date	2014 Year 07 Month 22 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	2016 Year 08 Month 19 Day
Last modified on	2016 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027275