UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041026 |
|---|---|
| Receipt number | R000046852 |
| Scientific Title | Study on Antioxidant Effect of Pleurotus cornucopiae = Evaluation using 8-OHdG in semen = |
| Date of disclosure of the study information | 2020/07/07 |
| Last modified on | 2022/01/06 13:33:37 |
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Basic information
Public title
Study on Antioxidant Effect of Pleurotus cornucopiae = Evaluation using 8-OHdG in semen =
Acronym
Study on Antioxidant Effect of Pleurotus cornucopiae
Scientific Title
Study on Antioxidant Effect of Pleurotus cornucopiae = Evaluation using 8-OHdG in semen =
Scientific Title:Acronym
Study on Antioxidant Effect of Pleurotus cornucopiae
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Endocrinology and Metabolism | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the antioxidant effect and the effect on semen findings of Pleurotus cornucopiae.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Semen findings (volume, concentration, sperm motility)
Semen components (creatine concentration,8-OHdG concentration)
before and after ingesting the test food
Key secondary outcomes
In vitro fertilization index (fertilization rate, blastocyst arrival rate, pregnancy rate, etc.)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take 6 tablets of biogot tablets, which are tamugitake supplements, for 2 weeks
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
| Not applicable |
Gender
Male
Key inclusion criteria
1. Patients who visited a male infertility clinic.
2. Semen findings: Sperm concentration: 5 million/ml or more, Sperm motility: 5% or more
3. Men over 20 years old
Key exclusion criteria
1.Those who are allergic to the components of the supplement
2.Those who have taken biogot supplements or Tamogi bamboo supplements before administration
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Terai |
Organization
Sugiyama clinic shinjuku
Division name
Urology department
Zip code
160-0023
Address
1-19-6 Nishi Shinjuku, Shinjuku-ku, Tokyo Yamate Shinjuku Building
TEL
03-5381-3000
terai@sugiyama.or.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Terai |
Organization
Sugiyama clinic shinjuku
Division name
Urology department
Zip code
160-0023
Address
1-19-6 Nishi Shinjuku, Shinjuku-ku, Tokyo Yamate Shinjuku Building
TEL
03-5381-3000
Homepage URL
terai@sugiyama.or.jp
Sponsor or person
Institute
Sugiyama clinic shinjuku
Institute
Department
Personal name
Funding Source
Organization
Dantte 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
The Ethics Committee of Sugiyama clinic
Address
1-19-6 Nishi Shinjuku, Shinjuku-ku, Tokyo Yamate Shinjuku Building
Tel
03-5381-3000
terai@sugiyama.or.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 | 07 | Month | 07 | 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
20
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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 05 | 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 | 07 | Month | 07 | Day |
Last modified on
| 2022 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046852
