UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042928 |
|---|---|
| Receipt number | R000049001 |
| Scientific Title | Trial for reduction of anxiety and fatigue -open study- |
| Date of disclosure of the study information | 2022/01/13 |
| Last modified on | 2024/05/17 12:44:36 |
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Basic information
Public title
Trial for reduction of anxiety and fatigue -open study-
Acronym
Trial for reduction of anxiety and fatigue
Scientific Title
Trial for reduction of anxiety and fatigue -open study-
Scientific Title:Acronym
Trial for reduction of anxiety and fatigue
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of ingesting the test food for 4 weeks on anxiety and fatigue in women aged between 50 and 65 years.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fatigue
VAS score(anxiety fatigue)
QOL questionnaire (behavior changes)
Sleep questionnaire (SMH)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take 2 tablets of test food with water twice a day
Interventions/Control_2
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
| 50 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1. Aged 20 to under 65 at the time of informed consent.
2. Japanese females.
3. Those who are menopausal.
4. Those who do not need treatment but have anxiety of fatigue.
5. Those who feel more anxious than last year.
6. Those who can input electronic diary with smartphone / PC.
7. Those who understand the contents of the study and obtain written consent before the test based on the person's free will.
Key exclusion criteria
Subjects who
1. are currently receiving any types of medicines and/or Chinese medical treatment (except for the drugs taken as needed).
2. plan to change their lifestyle during the test.
3. have a serious illness such as liver, kidney, heart, respiratory tract, endocrine, metabolic disease, etc..
4. are receiving treatment for mental illness such as depression or anxiety disorder, or have a history of it.
5. May take sleeping pills/ sleep-inducing drugs during the test period, continuously or when they need.
6. Have been diagnosed with chronic fatigue syndrome.
7. Have had life events that affect their mind and body such as loss of important things within one month (death of relatives, loss of employment, divorce, pet death).
8. Take healthy foods or supplements daily. (acceptable if they can stop taking after obtaining consent.)
9. have a past and current medical history of drug or food allergy.
10. have participated in other clinical trials within one month before obtaining consent, or those who plan to participate during the trial period.
11. consume alcohol excessively (alcohol equivalent 60g or more / day).
12. have smoking habit.
13. have an irregular diet, or irregular life rhythms (work in shifts, work late at night etc.).
14. are judged by the investigator to be unsuitable for participating in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Nakamura |
Organization
Kunitachi Sakura Hospital
Division name
Chairman
Zip code
186-0002
Address
1-19-10 Higashi, Kunitachi-shi, Tokyo
TEL
042-577-1011
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD inc.
Institute
Department
Personal name
Funding Source
Organization
Integrate 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-3207-8161
jimukyoku@imeqrd.co.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
| 2022 | Year | 01 | Month | 13 | 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
| 2020 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 06 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049001
