Unique ID issued by UMIN | UMIN000009405 |
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Receipt number | R000011052 |
Scientific Title | Safety and efficacy of an extract containing Panax ginseng (ginseng) and Lepidium meyenii (maca). |
Date of disclosure of the study information | 2012/11/28 |
Last modified on | 2013/05/27 09:14:48 |
Safety and efficacy of an extract containing Panax ginseng (ginseng) and Lepidium meyenii (maca).
Safety and efficacy of an extract containing ginseng and maca.
Safety and efficacy of an extract containing Panax ginseng (ginseng) and Lepidium meyenii (maca).
Safety and efficacy of an extract containing ginseng and maca.
Japan |
Erectile Dysfunction
Medicine in general | Urology | Adult |
Others
NO
Panax ginseng and Lepidium meyenii are medicinal herbs which have been used in traditional medicine. Several trials have reported effects of improving sexual function by these extracts. The purpose of this study is to evaluate safety and efficacy of an extract containing Panax ginseng and Lepidium meyenii.
Safety,Efficacy
The primary endpoint is evaluation of safety as phase I trial. An evaluation of adverse events.
Efficacy for erectile dysfunction as phase II study. Effects on subjective well-being and erectile dysfunction were evaluated with the International Index of Erectile Function (IIEF-5).
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
An extract containing ginseng and maca is administered for 8 weeks.
Placebo tablets are administered for 8 weeks.
20 | years-old | <= |
70 | years-old | > |
Male
- Age: more than or equal to 20 years at the time of providing informed consent
- Healthy individuals or male subjects with mild to moderate ED, erectile dysfunction.
- Individuals who have never experienced psychological and critical diseases.
- Individuals who have the ability to provide written informed consent.
- Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc) and who is taking any drugs.
- Subjects judged to be inappropriate for the study by the investigator.
30
1st name | |
Middle name | |
Last name | Seika Kamohara MD, PhD |
DHC Corporation
Division of Research Adviser
Minami-azabu 2-7-1, Minato-ku, Tokyo
1st name | |
Middle name | |
Last name | Seika Kamohara MD, PhD |
DHC Corporation
Division of Research Adviser
kamohara-seika@umin.ac.jp
DHC Corporation
DHC Corporation
Profit organization
Suidobashi Medical Clinic
NO
2012 | Year | 11 | Month | 28 | Day |
Unpublished
Completed
2012 | Year | 08 | Month | 31 | Day |
2012 | Year | 09 | Month | 01 | Day |
2012 | Year | 11 | Month | 27 | Day |
2013 | Year | 05 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011052
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