A Phase 4 interventional study of KBMSI-2 in Erectile Dysfunction, sponsored by Hyun Jun Park. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-08-29.
Sponsored by Hyun Jun Park · Phase 4, Interventional, and Treatment
Background: KBMSI-2, which is the herbal formular consisted of Ginseng Radix Rubra, Dioscorea tenuipes, Cornus officinalis Sieb. Et Zucc, Lycium Chinese Mill, Curcuma logna Linn, Honey, improved the erectile function by preserving the smooth muscle content and inhibiting the fibrosis of the corpus cavernosum in STZ-induced diabetic rat model. In this study, the researchers investigated the efficacy and safety of the herbal formula (KBMSI-2) in the treatment of ED.
Material and Methods: Patients were instructed to take investigational products (KBMSI-2 6g or placebo) twice a day for 8 weeks at least 1 hour after food intake. The primary efficacy variable was the change in the EF domain scores of the IIEF questionnaire from baseline. Secondary efficacy measures included change in all domain scores of the IIEF from baseline, change in question 2 and 3 of the SEP2,3, from baseline.
682 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.
This study's enrollment of 44 is below the median of 72 across 541 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →This is the only study on the registry with Hyun Jun Park as lead sponsor.
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Exclusion criteria were as follows:
Patients were instructed to take investigational products (KBMSI-2 6g) twice a day for 8weeks at least 1 hour after food intake
Drug: KBMSI-2
Patients were instructed to take placebo twice a day for 8weeks at least 1 hour after food intake
Drug: KBMSI-2
The KBMSI-2 capsules (6gm/capsule) and placebo were provided by Korean Bio Medical Science Institute (Seoul, Korea). KBMSI-2 was analyzed by high-performance liquid chromatography. KBMSI-2 contained major ginsenoside-Rb1: 260.53ug/g, -Rb2: 543.91ug/g, -Rc: 424.92ug/g, -Re: 377.32ug/g, -Rf: 1160.55ug/g, -Rg1: 703.97ug/g, Curcumin 60.73ug/g, Allantoin 98.66ug.g, and Loganin 744.13ug/g. During the study period, two capsules were taken daily for 8 weeks. The placebo capsules were identical in shape, color, and taste.
Also known as: Better man (brand name)
Change in the EF domain scores of the IIEF questionnaire from baseline
calculated by comparing total scores from questions 1 to 5 and 15 from IIEF questionnaire
Time frame: Baseline, 4weeks, 8weeks
Change in all domain scores of the IIEF from baseline
Time frame: Baseline, 4weeks, 8weeks
change in question 2 and 3 of the Sexual Encounter Profile (SEP2: Were you able to insert your penis in your partner's vagina? SEP3: Did your erection last long enough for you to have a successful intercourse?) from baseline
change in question 2 and 3 of the Sexual Encounter Profile (SEP2: Were you able to insert your penis in your partner's vagina? SEP3: Did your erection last long enough for you to have a successful intercourse?) from baseline
Time frame: Baseline, 4weeks, 8weeks
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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