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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023693
Receipt No. R000027275
Scientific Title Deveropment of Swallowing function improvement agents with ginger
Date of disclosure of the study information 2016/09/01
Last modified on 2016/08/19

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Basic information
Public title Deveropment of Swallowing function improvement agents with ginger
Acronym Deveropment of Swallowing function improvement agents with ginger
Scientific Title Deveropment of Swallowing function improvement agents with ginger
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Mitsuhiko Miyamura
Organization Kochi medical school hospital
Division name Pharmacy
Zip code
Address 185-1, kohasu, oko, nankoku, kochi, Japan
TEL 088-880-2549
Email im55@kochi-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kohei Jobu
Organization Kochi medical school hospital
Division name Pharmacy
Zip code
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

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
2016 Year 09 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 Enrolling by invitation
Date of protocol fixation
2014 Year 02 Month 14 Day
Date of IRB
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

Other
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

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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