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Recruitment status Completed
Unique ID issued by UMIN UMIN000015103
Receipt No. R000017578
Scientific Title Effects of mountain ginseng(Panax ginseng C.A. Meyer) on the improvement for male sexual function.
Date of disclosure of the study information 2014/09/10
Last modified on 2014/09/10

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Basic information
Public title Effects of mountain ginseng(Panax ginseng C.A. Meyer) on the improvement for male sexual function.
Acronym Effects of mountain ginseng(Panax ginseng C.A. Meyer) on the improvement for male sexual function.
Scientific Title Effects of mountain ginseng(Panax ginseng C.A. Meyer) on the improvement for male sexual function.
Scientific Title:Acronym Effects of mountain ginseng(Panax ginseng C.A. Meyer) on the improvement for male sexual function.
Region
Japan

Condition
Condition Erectile Dysfunction
Classification by specialty
Medicine in general Urology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of tissue-cultured mountain ginseng (Panax ginseng C.A. Meyer) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration:4weeks
Test material:Mountain ginseng 200mg
Three capsules per day (200mg/day)
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
35 years-old <=
Age-upper limit
70 years-old >=
Gender Male
Key inclusion criteria (1) Males between the age of 35 and 70.

(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 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shukuko EBIHARA
Organization Chiyoda para medical care clinic
Division name Clinic Director
Zip code
Address 2F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL 03-5297-5548
Email cpcc-contact@cpcc.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuhisa SAKANO
Organization CPCC Company Limited
Division name Clinical Research Planning Department
Zip code
Address 4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL 03-5927-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute Omnica Co., Ltd
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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 09 Month 10 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 03 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 08 Day
Last follow-up date
2014 Year 05 Month 06 Day
Date of closure to data entry
2014 Year 05 Month 14 Day
Date trial data considered complete
2014 Year 05 Month 16 Day
Date analysis concluded
2014 Year 05 Month 29 Day

Other
Other related information

Management information
Registered date
2014 Year 09 Month 10 Day
Last modified on
2014 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017578


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