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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043288
Receipt No. R000049422
Scientific Title Effect of ingestion of fermented black maca-containing food "Aged black maca Macarhythm" on fatigue and QOL Placebo-controlled, double-blind, randomized, controlled trial
Date of disclosure of the study information 2022/06/17
Last modified on 2021/02/09

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Basic information
Public title Effect of ingestion of fermented black maca-containing food "Aged black maca Macarhythm" on fatigue and QOL
Placebo-controlled, double-blind, randomized, controlled trial

Acronym Effect of ingestion of fermented black maca-containing food "Aged black maca Macarhythm" on fatigue and QOL
Scientific Title Effect of ingestion of fermented black maca-containing food "Aged black maca Macarhythm" on fatigue and QOL
Placebo-controlled, double-blind, randomized, controlled trial
Scientific Title:Acronym Effect of ingestion of fermented black maca-containing food "Aged black maca Macarhythm" on fatigue and QOL
Region
Japan

Condition
Condition healthy individuals
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For male and female subjects who are tired on a daily basis, we will continue to ingest fermented black maca-containing foods for 4 weeks and examine the effects on fatigue and QOL.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CFS (Chalder Fatigue Scale)
Fatigue VAS
QOLVAS
Athens Insomnia Scale
OSA sleep questionnaire
Urine frequency
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
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 Ingestion of study food for 4 weeks
Interventions/Control_2 Ingestion of control food substance 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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) Subjects of men and women aged 20 to 80
(2) Subjects who are tired on a daily basis
(3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Key exclusion criteria (1) Subjects with a history of liver disease, renal disease, digestive system disease, heart disease, respiratory disease, peripheral angiopathy, and other diseases that may affect the results of this study, or subjects with a history of surgery
(2) Subjects with diseases currently being treated
(3) Subjects who have been diagnosed with psychiatric disorders such as chronic insomnia, depression, anxiety disorders, and schizophrenia
(4) Subjects with food and drug allergies
(5) Subjects on a diet
(6) Subjects with irregular lives
(7) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(8) Subjects who are continuously taking medicines (including OTC and prescription medicines)
(9) Subjects taking excessive alcohol intake
(10) Subjects who cannot stop drinking from the day before the test to the day of the test
(11) Pregnant, lactating, or prospective pregnant or lactating subjects during the study period
(12) Subjects who are participating in or will participate in other clinical trials at the start of this study, and within 4 weeks after the end of the study.
(13) Other subjects judged by the investigator to be inappropriate
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name MIura
Organization Miura Clinic, Medical Corporation Kanonkai
Division name Internal Medicine
Zip code 530-0044
Address Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL 0661355200
Email info@miura-cl.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Terashima
Organization Oneness Support Co., Ltd.
Division name Clinical Trial Division
Zip code 530-0044
Address Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL 0648018917
Homepage URL
Email mterashima@oneness-sup.co.jp

Sponsor
Institute Miura Clinic, Medical Corporation Kanonkai
Institute
Department

Funding Source
Organization Fraijeu 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 Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel 0661355200
Email 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 医療法人花音会みうらクリニック(大阪府) Miura Clinic, Medical Corporation Kanonkai(Osaka)

Other administrative information
Date of disclosure of the study information
2022 Year 06 Month 17 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 01 Month 26 Day
Date of IRB
2021 Year 01 Month 28 Day
Anticipated trial start date
2021 Year 02 Month 16 Day
Last follow-up date
2021 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
2021 Year 02 Month 09 Day
Last modified on
2021 Year 02 Month 09 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049422

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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