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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036485
Receipt No. R000041570
Scientific Title Effect of the compound supplements on QOL in adult men after ingestion of the supplements for 8 weeks
Date of disclosure of the study information 2019/04/15
Last modified on 2019/04/12

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Basic information
Public title Effect of the compound supplements on QOL in adult men
Acronym Effect of the compound supplements on QOL in adult men
Scientific Title Effect of the compound supplements on QOL in adult men after ingestion of the supplements for 8 weeks
Scientific Title:Acronym Effect of the compound supplements on QOL in adult men after ingestion of the supplements for 8 weeks
Region
Japan

Condition
Condition Male menopausal symptoms
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of the compound supplements on QOL in adult men after ingestion of the supplements for 8 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in fatigue VAS after ingestion of the supplements for 8 weeks.
Key secondary outcomes Changes in AMS score anti aging,QOL total blood testosterone and free blood testosteronea after ingestion of the supplements for 8 weeks.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male
Key inclusion criteria 1)Japanese male aged 20 to 75 at the time of informed consent.
2)Subjects who made a visit to outpatient clinic for male menopause and are diagnosed not to need medication for male menopause symptoms.
3) Subjects who need watch and wait and decide to use health food and the like by their own will for the purpose of nutrition support that is insufficient in the diet..
4) Subjects who will intake the compound supplements.
Key exclusion criteria 1)Subjects who are suspected to have serious disease such as digestive, liver, kidney, circulatory, blood, and endocrine disorder or who have the history of these disorders.
2) Subjects who are judged to require testosterone replacement therapy at outpatient clinic
3)Subjects who are judged to require administration of PDE-5 inhibitor at outpatient clinic
4)Subjects who are judged to require the administration of antidepressants or anti-anxiety drug at outpatient clinics
5)Subjects who are currently taking a supplement which contains a same functional substance as the compound supplements
6)Subjects who may cause allergic reactions to foods
7)Subjects who are heavy smoker or heavy user of alcohol
8)Subjects who are judged as unsuitable for the study by the investigator with other reasons.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kei
Middle name
Last name Yui
Organization FANCL Corporation
Division name Research Institute
Zip code 045-820-3569
Address Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa
TEL 045-820-3659
Email tsubokawa_masaya@fancl.co.jp

Public contact
Name of contact person
1st name Isao
Middle name
Last name Takehara
Organization Clinical Support Corpration
Division name Food Service Division
Zip code 060-0061
Address 12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL 045-820-3569
Homepage URL
Email takehara@csc-smo.co.jp

Sponsor
Institute FANCL Corporation
Institute
Department

Funding Source
Organization FANCL Corporation
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 Medical corporation Hokubukai beauty hill hospital ethics review committee
Address No. 61, Maeda, Kiyota-ku, Sapporo, Hokkaido
Tel 011-882-0111
Email wakimoto@ughp-cpc.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
2019 Year 04 Month 15 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
2019 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 15 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 04 Month 12 Day
Last modified on
2019 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041570

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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