UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025127 |
|---|---|
| Receipt number | R000028896 |
| Scientific Title | A verification study on effects of improvement sexual function in male: A randomized double-blind placebo-controlled comparison trial |
| Date of disclosure of the study information | 2016/12/02 |
| Last modified on | 2018/05/11 11:05:11 |
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Basic information
Public title
A verification study on effects of improvement sexual function in male: A randomized double-blind placebo-controlled comparison trial
Acronym
A verification study on effects of improvement sexual function in male
Scientific Title
A verification study on effects of improvement sexual function in male: A randomized double-blind placebo-controlled comparison trial
Scientific Title:Acronym
A verification study on effects of improvement sexual function in male
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of test food ingestion on improvement sexual function in male
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
International Index of Erectile Function (IIEF) Japanese version
Key secondary outcomes
1.Blood test
High-sensitivity PSA
Free testosterone
2.Mearsurement of nocturnal penile tumescence during night sleep
3.Subjects symptoms
Androgen decline in the aging male questionnaire
VAS (Visual Analogue Scale)
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Period : 12 weeks
Test materials: Pseudoginseng capsule
Does: 1 capsule for once a day
Administration: Take 1 capsule with water during after dinner and before going to bed
*If you forget to take the capsule, take it as soon as you remember
Interventions/Control_2
Period : 12 weeks
Test materials: Placebo capsule
Does: 1 capsule for once a day
Administration: Take 1 capsule with water during after dinner and before going to bed
*If you forget to take the capsule, take it as soon as you remember
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
Healthy Japanese men who feel declining in sexual functions
Key exclusion criteria
1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
3. Those who have erectile dysfunction (ED) and under treatment of prostatic hyperplasia or have medical history
4. Currently taking medicines and/or herbal medicines, particularly using anticoagulants such as Warfarin
5. Those who eat and/or drink Food for Specified Health Uses and/or Food with Function Claims on a daily basis
6. Allergic to medicines or foods related to test foods of this trial
7. Another clinical test participant within three months before the informed consent form submission
8. Others assessed as inappropriate for this test by the doctor responsible for the test
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
SANWA INTERNATIONAL INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seishin-kai Medical Association Inc, Takara Medical Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Yamashita S, Shiga M, Oshima Y, Ono H, Suzuki N, Iio S, Takara T. Effects of Sanch ginseng Extract on the Sexual Function in Japanese Men-A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial-. Jpn Pharmacol Ther. 2018; 46(4): 561-580.
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
| 2016 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 02 | Day |
Last modified on
| 2018 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028896
