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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039208
Receipt No. R000044654
Scientific Title Randomized comparative study on the spermatogenesis function of mixed supplements and Hochuekkito.
Date of disclosure of the study information 2020/01/21
Last modified on 2020/01/21

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Basic information
Public title Randomized comparative study on the spermatogenesis function of mixed supplements and Hochuekkito.
Acronym Randomized comparative study on the spermatogenesis function of mixed supplements and Hochuekkito.
Scientific Title Randomized comparative study on the spermatogenesis function of mixed supplements and Hochuekkito.
Scientific Title:Acronym Randomized comparative study on the spermatogenesis function of mixed supplements and Hochuekkito.
Region
Japan

Condition
Condition asthenozoospermia
oligozoospermia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 efficiency
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes improve semen analysis parameter
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 antioxidant supplement
three times a day for 12-week
Interventions/Control_2 Hochuu-Ekki-to
Onece 2.5g three times a day for 12-week
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
60 years-old >=
Gender Male
Key inclusion criteria Infertile male patients with oligo- and/or asthenozoospermia who agreed to participate in our study.
Key exclusion criteria Patients with azoospermia, severe oligozoospermia (sperm concentration less than 5 million/mL), and severe asthenozoospermia (sperm motility less than 5%) were excluded.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Kazutaka
Middle name
Last name Terai
Organization Juntendo university
Division name Department of Urology
Zip code 113-8431
Address Hongo 3-1-3, Bunkyo-ku, Tokyo 113-8431, Japan
TEL 03-3813-3111
Email k-terai@juntendo.ac.jp

Public contact
Name of contact person
1st name Akira
Middle name
Last name Tsujimura
Organization Juntendo University Urayasu Hospital
Division name Department of Urology
Zip code 279-0021
Address 2-1-1 Tomioka, Urayasu, Chiba
TEL +81-47-353-3111
Homepage URL
Email atsujimu@juntendo.ac.jp

Sponsor
Institute Juntendo University Hospital
Institute
Department

Funding Source
Organization no
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University Hospital
Address Hongo 3-1-3, Bunkyo-ku, Tokyo 113-8431, Japan
Tel 03-3813-3111
Email k-terai@juntendo.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

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 21 Day

Related information
URL releasing protocol https://onlinelibrary.wiley.com/doi/full/10.1002/rmb2.12308
Publication of results Published

Result
URL related to results and publications https://onlinelibrary.wiley.com/doi/full/10.1002/rmb2.12308
Number of participants that the trial has enrolled 31
Results Total motile sperm count was significantly improved in supplement group.
Results date posted
2020 Year 01 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics male infertile patients
Participant flow Anti oxidant supplement group: 15
Tochu-ekki-to group: 16
Adverse events no
Outcome measures semen analysis: semen volume, sperm concentration, sperm motility, total motile sperm count
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 07 Month 01 Day
Date of IRB
2016 Year 06 Month 16 Day
Anticipated trial start date
2016 Year 09 Month 30 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 20 Day
Last modified on
2020 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044654

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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