UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023693 |
|---|---|
| Receipt number | 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 17:12:51 |
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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
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
im55@kochi-u.ac.jp
Public contact
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
jm-kouheij@kochi-u.ac.jp
Sponsor or person
Institute
Kochi medical school hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027275
