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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000042928
Receipt No. 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 2021/04/15

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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
Email higashikoganeisakura-clinic@imeq.co.jp

Public contact
Name of contact person
1st name Yoshitada
Middle name
Last name Hira
Organization IMEQRD inc.
Division name Sales department
Zip code 104-0061
Address 6-2-1 Ginza Chuo-ku Tokyo
TEL 03-6704-5968
Homepage URL
Email y-hira@imeqrd.co.jp

Sponsor
Institute IMEQRD inc.
Institute
Department

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
Email suda-clinic_irb@imeq.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
2021 Year 04 Month 15 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049001

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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