UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053746 |
|---|---|
| Receipt number | R000061318 |
| Scientific Title | A Study on the Effect of Food Containing Plant Extract on Sleep Problems -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/03/01 11:36:03 |
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Basic information
Public title
A Study on the Effect of Food Containing Plant Extract on Sleep Problems
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym
A Study on the Effect of Food Containing Plant Extract on Sleep Problems
Scientific Title
A Study on the Effect of Food Containing Plant Extract on Sleep Problems
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym
A Study on the Effect of Food Containing Plant Extract on Sleep Problems
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of food containing plant extract on sleep problems.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indexes on sleeping
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Food containing plant extract, 8 weeks consumption
Interventions/Control_2
Food not containing plant extract, 8 weeks consumption
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese males and females aged 20 to 79 years-old.
2) Subjects who tend to feel frequent urination and sleep trouble.
3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1) Subjects who are currently attending hospital or have a current medical history of a disease that could affect the study.
2) Subjects who are suspected of having overactive bladder in the OABSS score.
3) Subjects who are suspected of having benign prostatic hyperplasia.
4) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption.
5) Subjects who regularly use medications affecting the study.
6) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting urination and/or sleep.
7) Subjects who are shiftworker, midnight worker and/or hard worker.
8) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
9) Subjects who are pregnant or planning to become pregnant or breastfeed during the study period.
10) Subjects who live with a person requiring nursing care, and/or who are raising an infant or child.
11) Subjects who are allergic to test foods.
12) Subjects who are participating or intend to participate in other clinical trials that may affect the study at the time of commencement of the study.
13) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Saeko |
| Middle name | |
| Last name | Isaka |
Organization
TOYO SHINYAKU Co., Ltd.
Division name
Clinical and analytical research center
Zip code
841-0005
Address
7-28 Yayoigaoka, Tosu-Shi, Saga, Japan
TEL
0942-81-3555
isakas@toyoshinyaku.co.jp
Public contact
Name of contact person
| 1st name | Nobutaka |
| Middle name | |
| Last name | Kusaba |
Organization
TOYO SHINYAKU Co., Ltd.
Division name
Clinical and analytical research center
Zip code
841-0005
Address
7-28 Yayoigaoka, Tosu-Shi, Saga, Japan
TEL
0942-81-3555
Homepage URL
gakujutsu@toyoshinyaku.co.jp
Sponsor or person
Institute
TOYO SHINYAKU Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miura Clinic, Medical Corporation Kanonkai IRB
Address
9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
Tel
06-6135-5200
mterashima@miura-cl.jp
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
| 2024 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061318
