- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02413099
The Efficacy and Safety of New Herbal Formula (KBMSI-2) in the Treatment of Erectile Dysfunction
The Efficacy and Safety of New Herbal Formula (KBMSI-2) in the Treatment of Erectile Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Busan, Korea, Republic of, 602-739
- Department of Urology, Pusan National University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria were as follows:
- men with history of ED for at least 6 months according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance);
- erectile function (EF) domain scores of the International Index of Erectile Function (IIEF) questionnaire ≤ 25;
- age range between 19 and 40 years old;
- patients were required to be involved in a stable, monogamous relationship with a female sexual partner and having failed >50% of at least four sexual attempts during the run-in period.
Exclusion criteria were as follows:
- Men with the following conditions were excluded from the study:
- penile anatomical defects,
- spinal cord injury,
- radical prostatectomy,
- and radical pelvic surgery;
- a primary diagnosis of another sexual disorder;
- uncontrolled DM (HBA1C> 12%);
- serum creatinine>2.5mg/dL;
- major uncontrolled psychiatric disorder;
- history of major hematological, renal, or hepatic abnormalities;
- recent (within the previous 6 months) history of cardiovascular disease, stroke or myocardial infarction, cardiac failure, unstable angina, life-threatening arrhythmia and a history of alcoholism or substance abuse.
- Patients having taken PDE5 inhibitors and testosterone replacement therapy within 2 weeks were excluded in the study. Concomitant use of ED treatment was forbidden.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: KBMSI-2 6gm
Patients were instructed to take investigational products (KBMSI-2 6g) twice a day for 8weeks at least 1 hour after food intake
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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.
Other Names:
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Placebo Comparator: Placebo
Patients were instructed to take placebo twice a day for 8weeks at least 1 hour after food intake
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the EF domain scores of the IIEF questionnaire from baseline
Time Frame: Baseline, 4weeks, 8weeks
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calculated by comparing total scores from questions 1 to 5 and 15 from IIEF questionnaire
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Baseline, 4weeks, 8weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in all domain scores of the IIEF from baseline
Time Frame: Baseline, 4weeks, 8weeks
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Baseline, 4weeks, 8weeks
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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
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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
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Baseline, 4weeks, 8weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KBMSI-2 Study
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