UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034812 |
|---|---|
| Receipt number | R000039615 |
| Scientific Title | Study on improvement of sleeping disorder by ingestion of mixed fermented tea leaf powder made from unripe orange fruits and green tea leaves(2) |
| Date of disclosure of the study information | 2018/11/22 |
| Last modified on | 2019/03/14 15:44:11 |
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Basic information
Public title
Study on improvement of sleeping disorder by ingestion of mixed fermented tea leaf powder made from unripe orange fruits and green tea leaves(2)
Acronym
Study on improvement of sleeping disorder by ingestion of mixed fermented tea leaf powder(2)
Scientific Title
Study on improvement of sleeping disorder by ingestion of mixed fermented tea leaf powder made from unripe orange fruits and green tea leaves(2)
Scientific Title:Acronym
Study on improvement of sleeping disorder by ingestion of mixed fermented tea leaf powder(2)
Region
| Japan |
Condition
Condition
sleeping disorder
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of ingention fermented tea leaf powder on the improvement of sleeping disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sleeping disorder
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
The subjects ingested the placebo meal for two weeks,and ingented the active meal for two weeks after two weeks.
Interventions/Control_2
The subjects ingested the active meal for two weeks,and ingented the active meal for two weeks after two weeks.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Aged more than 20 (Healthy male and female between 20 and 70 years old)
2) Individuals who has subjective symptoms of sleeping disorder
3) Individuals who can refrain from over drinking and over eating during the test period
4) Individuals who understand the purpose and contents of the experiment
Key exclusion criteria
1)Subjects who are contracting or treating severe kidney and/or liver diseases
2)Individuals who have a chronic diseases and regularly use drugs
3)Those who can not stop taking a large amount of green tea or black tea during the test period
4)Pregnant women, or women with intending to become pregnant, and lactating woman
5)Individuals participating or intending to participate in a drug administration test
6)Individuals judged by the doctor to be unsuitable
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunari Tanaka |
Organization
Univercity of Nagasaki
Division name
Faculty of Nursing and Nutrition
Zip code
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL
0958135216
katanaka@sun.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Ito |
Organization
Univercity of Nagasaki
Division name
Regional Partnership Center
Zip code
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL
0958135500
Homepage URL
katanaka@sun.ac.jp
Sponsor or person
Institute
Univercity of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
Bio-oriented Technology Research Advancement Institution,NARO
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2018 | Year | 11 | Month | 22 | 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
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 08 | Day |
Last modified on
| 2019 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039615
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
