UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015931 |
|---|---|
| Receipt number | R000018542 |
| Scientific Title | Effects of mountain ginseng(Panax ginseng C.A. Meyer) short-term intake, on the improvement for male sexual function and in fatigue. |
| Date of disclosure of the study information | 2014/12/12 |
| Last modified on | 2015/03/10 11:37:25 |
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Basic information
Public title
Effects of mountain ginseng(Panax ginseng C.A. Meyer) short-term intake, on the improvement for male sexual function and in fatigue.
Acronym
Effects of mountain ginseng(Panax ginseng C.A. Meyer) short-term intake, on the improvement for male sexual function and in fatigue.
Scientific Title
Effects of mountain ginseng(Panax ginseng C.A. Meyer) short-term intake, on the improvement for male sexual function and in fatigue.
Scientific Title:Acronym
Effects of mountain ginseng(Panax ginseng C.A. Meyer) short-term intake, on the improvement for male sexual function and in fatigue.
Region
| Japan |
Condition
Condition
Erectile Dysfunction
Classification by specialty
| Medicine in general | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of tissue-cultured mountain ginseng (Panax ginseng C.A. Meyer) short-term intake, on male with erectile dysfunction and fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
International Index of Erectile Function and Aging Male Symptoms rating scale.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 7days
Test material: Placebo
4 capsules per day
Interventions/Control_2
Duration: 7days
Test material: Mountain ginseng 200mg
4 capsules per day (200mg/day)
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
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Males between the age of 20 and 49.
(2) Males who have the sexual decline.
(3) Subjects who answered IIEF5(International Index of Erectile Function 5) score more than /equal 21.
(4) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1) Subjects who are allergic to food related to the test material of this trial.
(2) Subjects who have previous medical history of the serious diseases (heart, liver, kidney, blood, digestive system,metabolism system)
(3) Subjects who are under treatment for hypertension, or who untreated hypertension (not less than level 2).
(4) Subjects who contract or are under treatment for diseases of prostatic.
(5) Subjects who are under treatment for diabetes.
(6) Subjects who are judged as inappropriate for this study by physicians.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruo MARUYAMA |
Organization
Universal Clinical Systems Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
4F Komori Build. 2-5-3 Kyobashi Chuo-ku, Tokyo Japan
TEL
03-3816-3121
info@uc-system.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MARIKO MOMOI |
Organization
Omnica Co.,Ltd
Division name
Research team
Zip code
Address
TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5840-9815
Homepage URL
momoi@omnica.co.jp
Sponsor or person
Institute
Universal Clinical Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Omnica 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
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 12 | 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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 15 | 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
| 2014 | Year | 12 | Month | 12 | Day |
Last modified on
| 2015 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018542
