The Efficacy and Safety of New Herbal Formula (KBMSI-2) in the Treatment of Erectile Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
KBMSI-2
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
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.
Sites / Locations
- Department of Urology, Pusan National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KBMSI-2 6gm
Placebo
Arm Description
Patients were instructed to take investigational products (KBMSI-2 6g) twice a day for 8weeks at least 1 hour after food intake
Patients were instructed to take placebo twice a day for 8weeks at least 1 hour after food intake
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in all domain scores of the IIEF 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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02413099
Brief Title
The Efficacy and Safety of New Herbal Formula (KBMSI-2) in the Treatment of Erectile Dysfunction
Official Title
The Efficacy and Safety of New Herbal Formula (KBMSI-2) in the Treatment of Erectile Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
January 3, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hyun Jun Park
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KBMSI-2 6gm
Arm Type
Experimental
Arm Description
Patients were instructed to take investigational products (KBMSI-2 6g) twice a day for 8weeks at least 1 hour after food intake
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients were instructed to take placebo twice a day for 8weeks at least 1 hour after food intake
Intervention Type
Drug
Intervention Name(s)
KBMSI-2
Other Intervention Name(s)
Better man (brand name)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the EF domain scores of the IIEF questionnaire from baseline
Description
calculated by comparing total scores from questions 1 to 5 and 15 from IIEF questionnaire
Time Frame
Baseline, 4weeks, 8weeks
Secondary Outcome Measure Information:
Title
Change in all domain scores of the IIEF from baseline
Time Frame
Baseline, 4weeks, 8weeks
Title
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
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Urology, Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of New Herbal Formula (KBMSI-2) in the Treatment of Erectile Dysfunction
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