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

Email

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


Email

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


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

Value
https://center6.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