Erectile DysfunctionPhase 4NCT02413099
The Efficacy and Safety of New Herbal Formula (KBMSI-2) in the Treatment of Erectile Dysfunction
A Phase 4 study testing KBMSI-2 in people with Erectile Dysfunction, run by Hyun Jun Park at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 40 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- KBMSI-2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to 3 Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Urology, Pusan National University Hospital
Busan, 602-739
About this study
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
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.
- Conditions
- Erectile Dysfunction
- Being tested
- KBMSI-2
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KBMSI-2Drug
Also called Better man (brand name)
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.
| Study group | Role | What they receive |
|---|---|---|
| KBMSI-2 6gm | Experimental | Patients were instructed to take investigational products (KBMSI-2 6g) twice a day for 8weeks at least 1 hour after food intake Receives: Drug: KBMSI-2 |
| Placebo | Placebo comparator | Patients were instructed to take placebo twice a day for 8weeks at least 1 hour after food intake Receives: Drug: KBMSI-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 4weeks, 8weeks
Secondary outcomes (2)
Change in all domain scores of the IIEF from baseline
Measured: 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
Measured: Baseline, 4weeks, 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startFeb 2012
- Primary completionNov 2012
- Study completion3 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyun Jun Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hyun Jun Park, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413099
- Sponsor's protocol ID
- KBMSI-2 Study
- Status last verified
- Aug 2018
- First submitted
- 6 Apr 2015
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02413099
- Acronym / sponsor ID
- KBMSI-2 Study
- Conditions
- Erectile Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hyun Jun ParkUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- 3 Jan 2013 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KBMSI-2 6gm | Experimental | Drug: KBMSI-2Patients were instructed to take investigational products (KBMSI-2 6g) twice a day for 8weeks at least 1 hour after food intake |
| Placebo | Placebo comparator | Drug: KBMSI-2Patients were instructed to take placebo twice a day for 8weeks at least 1 hour after food intake |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- Men with the following conditions were excluded from the study:
- penile anatomical defects,
- spinal cord injury,
- radical prostatectomy,
- and radical pelvic surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KBMSI-2Also: Better man (brand name)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. | Drug | KBMSI-2 6gm, Placebo |
Primary outcome
Change in the EF domain scores of the IIEF questionnaire from baseline
Time frame: Baseline, 4weeks, 8weeks
calculated by comparing total scores from questions 1 to 5 and 15 from IIEF questionnaire
2 secondary outcomes
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
Time frame: Baseline, 4weeks, 8weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing KBMSI-2 in people with Erectile Dysfunction, run by Hyun Jun Park at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the EF domain scores of the IIEF questionnaire from baseline (time frame: Baseline, 4weeks, 8weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.