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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038641
Receipt No. R000042542
Scientific Title Double blind Study of arabinogalactane derived from Hyuganatsu orange to bone metabolism.
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/20

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Basic information
Public title Double blind Study of arabinogalactane derived from Hyuganatsu orange to bone metabolism.
Acronym DB-SAHBo Study (Double blind study of arabinogalactane derived from Hyuganatsu orange to bone metabolism)
Scientific Title Double blind Study of arabinogalactane derived from Hyuganatsu orange to bone metabolism.
Scientific Title:Acronym DB-SAHBo Study (Double blind study of arabinogalactane derived from Hyuganatsu orange to bone metabolism)
Region
Japan

Condition
Condition Prevention of the osteoporosis
Classification by specialty
Obsterics and gynecology Orthopedics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate serum TRACP5b level before and after taking Hyuganatsu orange juice containing arabinogalactane
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes TRACP5b concentration before and after intake of Hyuganatsu juice
Key secondary outcomes Effects of BAP, HS-PTH, P1NP and 25hydroxy vitamin D levels after intake of Hyuganatsu juice.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Hyuganatsu juice intake group; Take 125ml of Hyuganatsu juice containing arabinogalactane every day for 90days.
Interventions/Control_2 Take 125ml of Placebo drink, every day for 90days.
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
90 years-old >
Gender Female
Key inclusion criteria 1) Female at least 2 years after menopause
2) Volunteer after informed consent with written notice
Key exclusion criteria female with
1) elevated kidney and liver function data
2) suffering some disease that is known to
affect bone metabolism,such as bone fracture, Diabetes mellitus
3) taking medicine that affect bone metabolism, such as steroid, bisphosphonates.
4) allergy to orange.
5) persons who take orange at least one orange everyday within 3 months
6) Others
Target sample size 64

Research contact person
Name of lead principal investigator
1st name Masatoshi
Middle name
Last name Yamaguchi
Organization University of Miyazaki
Division name Department of OB/GYN
Zip code 889-1692
Address 5200 Kihara, Kiyotake-Cho, Miyazaki 889-1692, Japan
TEL +81985850988
Email myama@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name Masatoshi
Middle name
Last name Yamaguchi
Organization University of Miyazaki
Division name Department of OB/GYN
Zip code 889-1692
Address 5200 Kihara, Kiyotake-Cho, Miyazaki 889-1692, Japan
TEL +81985850988
Homepage URL
Email myama@med.miyazaki-u.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology, University of Miyazaki
Institute
Department

Funding Source
Organization MIYAZAKIKEN NOKYO KAJU CO. LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor 1) SOJO UNIVERSITY Faculty of Biotechnology and Life Science
2) Center for Collaborative Research & Community Cooperation University of Miyazaki
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of the University of Miyazaki of Medical Sciences
Address 5200, Kihara, Kiyotkecho, Miyazaki, Japan
Tel +81-985-85-9403
Email rinken@med.miyazaki-u.ac.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 宮崎大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 01 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 11 Month 30 Day
Date of IRB
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2020 Year 07 Month 28 Day
Date of closure to data entry
2020 Year 09 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 20 Day
Last modified on
2019 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042542

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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