A verification study on effects of improvement sexual function in male: A randomized double-blind placebo-controlled comparison trial

Not Applicable

• Conditions: Healthy adults

• Registration Number: JPRN-UMIN000025127
• Lead Sponsor: ORTHOMEDICO Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Index of Erectile Function (IIEF) Japanese version

Secondary Outcome Measures

Name	Time	Method
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)