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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045634
Receipt No. R000051430
Scientific Title A study to evaluate the effects of plant extract material on fatigue sensation and sleep
Date of disclosure of the study information 2021/10/02
Last modified on 2021/07/31

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Basic information
Public title A study to evaluate the effects of plant extract material on fatigue sensation and sleep
Acronym A study to evaluate the effects of plant extract material on fatigue sensation and sleep
Scientific Title A study to evaluate the effects of plant extract material on fatigue sensation and sleep
Scientific Title:Acronym A study to evaluate the effects of plant extract material on fatigue sensation and sleep
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of test food for 4 weeks on fatigue sensation and sleep
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VAS(fatigue sensation)
Key secondary outcomes Chalder fatigue scale, POMS2 Japanese Adult Short version, OSA sleep inventory MA version, St. Mary's Hospital sleep questionnaire, autonomic nervous function evaluation, blood test, immunity evaluation, questionnaire on defecation, body weight, waist circumference, BMI

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 Prevention
Type of intervention
Food
Interventions/Control_1 Intake of test food for 4 weeks
Interventions/Control_2 Intake of placebo for 4 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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) Healthy males and females aged 20- 65 years
2) Subjects who perceive fatigue sensation in daily life
3) Subject whose BMI is 23.0 kg/m2 or more and less than 30.0 kg/m2
4) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria 1) Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2) Subjects with chronic fatigue syndrome (CFS) , or subjects deemed to have severe fatigue such as idiopathic chronic fatigue by the investigator
3) Subjects receiving a medical treatment for sleep disorders
4) Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutritional supplements during physical fatigue
5) Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation
6) Subjects who take pharmaceuticals or quasi-drugs which having the efficacy for improving sleep quality
7) Subjects who take Foods with Function Claims labeled the effect of improving sleep quality
8) Subjects whose lifestyles are irregular because of night shift or others
9) Subjects who have the possibility of developing allergic symptoms by the test food
10) Female subjects who are pregnant or lactating, or intending to become pregnant during the study
11) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
12) Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study
13) Subjects deemed unsuitable by the investigator
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Inamasu
Organization Kracie Holdings, Ltd.
Division name R&D Innovation Group
Zip code 108-8080
Address 3-20-20, Kaigan, Minato-ku, Tokyo
TEL 070-3350-0767
Email s.inamasu@kracie.co.jp

Public contact
Name of contact person
1st name Kota
Middle name
Last name Watanabe
Organization Soiken Inc.
Division name R&D Division
Zip code 560-0082
Address Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka-shi, Osaka
TEL 06-6871-8888
Homepage URL
Email watanabe_kota@soiken.com

Sponsor
Institute Soiken Inc.
Institute
Department

Funding Source
Organization Kracie Holdings, 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 IRB of Fukuda Clinic
Address Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel 06-6398-0203
Email fukudaclinicIRB@gmail.com

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 医療法人弘正会ふくだ内科クリニック(大阪府)

Other administrative information
Date of disclosure of the study information
2021 Year 10 Month 02 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
2021 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2021 Year 10 Month 02 Day
Last follow-up date
2021 Year 11 Month 22 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 10 Month 01 Day
Last modified on
2021 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051430

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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