UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039208 |
|---|---|
| Receipt number | 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 14:16:35 |
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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
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
atsujimu@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044654
