Subjective effects of a proprietary Eurycoma longifolia and Polygonum minus combination on well-being and sexual performance in patients with mild erectile dysfunction
| ISRCTN | ISRCTN87153230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87153230 |
| Secondary identifying numbers | BIOT1000 |
- Submission date
- 14/11/2011
- Registration date
- 23/02/2012
- Last edited
- 08/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
The root of the flowering plant Eurycoma longifolia (Tongkat Ali) has been used as a traditional medicine and promoted as a tonic, energy enhancer, and aphrodisiac. In this study, a commercial product containing an extract of Eurycoma longifolia, ‘Physta’, was tested for its effectiveness and safety for improving sexual performance and well-being in men with reduced sexual potency. The product also contained an extract of Polygonum minus, added for its antioxidant benefits.
Who can participate?
Men aged 40-65 with mild erectile dysfunction.
What does the study involve?
Participants are randomly allocated to receive either a combination of extracts of Eurycoma longifolia and Polygonum minus, or an identical placebo (dummy), daily for 12 weeks. Participants complete erectile dysfunction and quality of life questionnaires at the start of the study and after 6 and 12 weeks.
What are the possible benefits and risks of participating?
Benefits include improved sexual performance, quality of life and well-being.
Where is the study run from?
Staywell Research clinical research site in Northridge, CA, USA.
When is the study starting and how long is it expected to run for?
September 2009 to August 2010.
Who is funding the study?
Biotropics Malaysia.
Who is the main contact?
Jay Udani
Contact information
Scientific
18250 Roscoe Boulevard Suite 220
Northridge, CA
91325
United States of America
Study information
| Study design | Randomized double-blind placebo-controlled parallel-design trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Subjective effects of a proprietary Eurycoma longifolia and Polygonum minus combination on well-being and sexual performance in patients with mild erectile dysfunction: a randomized controlled trial |
| Study hypothesis | The purpose of this study is to compare the effects of a proprietary Tongkat ali/Polygonum minus combination with placebo on well-being and sexual performance in patients with mild erectile dysfunction. |
| Ethics approval(s) | Copernicus Group Institutional Review Board, 14/09/2009 |
| Condition | Erectile dysfunction |
| Intervention | Males aged 40-65 with mild erectile dysfunction were studied as outpatients in this double- blind, randomized, placebo-controlled, parallel-group pilot trial. Participants, researchers, and individuals dealing with the data were blinded to the treatment group. Subjects received one of the following two interventions: identical placebo or 300mg of a combination of proprietary freeze-dried water extracts of Eurycoma longifolia + Polygonum minus daily for twelve weeks. Thirty men were randomized to the study (N=15 per group), and 26 completed the study (N=12 in the treatment group). These 26 subjects were included in the analysis. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Eurycoma longifolia + Polygonum minus |
| Primary outcome measure | 1. Index of Erectile Function (IIEF-5) is a six-point scale ranging from 0 to 5. The higher the score, the better the function 2. Erectile Dysfunction Inventory for Treatment Satisfaction (EDITS) Questionnaire is a point scale ranging from 0 to 4 3. Percentage of successful sexual intercourse attempts (SIA) (from patient event logs) 10 questions most of which are yes or no and are coded as 1 or 0, respectively 4. Erection Hardness Scale (EHS) is a four-point scale, with scores ranging from 1 to 4 5. Sexual Health Inventory Questionnaire is a six-point scale for each question, ranging from 0 to 5 6. Aging Male Symptom Score is a six-point Likert scale ranging from 0 to 5. A higher score indicates worse function Measured at screening, baseline, week 6, and week 12 |
| Secondary outcome measures | 1. Self-Esteem and Relationship Questionnaire (SEAR) uses a six-point Likert scale ranging from 0 to 5. A higher score indicates better function 2. Beck Depression Index and Beck Anxiety Index The Beck Depression Inventory and Beck Anxiety Inventory score individual items on a four-point scale (0-3). Scores across domains are summed. Total scores ≥21 indicate concern for depression. Measured at screening, baseline, week 6, and week 12 |
| Overall study start date | 22/09/2009 |
| Overall study end date | 11/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 26 |
| Participant inclusion criteria | 1. Male subjects between the ages of 40 and 65 at the time of screening, and in a stable heterosexual relationship for at least six months. Both partners had to agree to attempt intercourse at least once a week on average during the study. 2. Subjects with testosterone levels ≤ 450ng/dL 3. Index of erectile dysfunction scores between17-25 |
| Participant exclusion criteria | 1. Subjects with a history of prostate cancer, elevated prostate-specific antigen (PSA), benign prostate hypertrophy (BPH) scores ≥ 40, penile anatomical abnormalities, premature ejaculation 2. Cardiovascular disease, resting hypotension (resting systolic blood pressure <90mmHg) or hypertension (resting systolic blood pressure >170mmHg or diastolic pressure >110mmHg) 3. Primary hypoactive sexual desire 4. Seizures 5. Hereditary degenerative retinal disorders or loss of vision 6. Liver disease 7. Clinically significant chronic hematological disease, bleeding disorders 8. Significant active peptic ulceration 9. Symptomatic postural hypotension or syncope within the previous six months 10. Malignancy within the previous five years (other than squamous or basal cell) 11. A positive test for hepatitis B surface antigen or hepatitis C 12. Alcoholism (an alcohol screening score ≥2) 13. Congenital spinal cord deformities or traumatic injuries, congenital or traumatic brain injuries 13. An abnormal prostate exam during the screening visit |
| Recruitment start date | 22/09/2009 |
| Recruitment end date | 11/08/2010 |
Locations
Countries of recruitment
- United States of America
Study participating centre
91325
United States of America
Sponsor information
Industry
Level 52, North Wing
Menara TM
Jalan Pantai Baharu
Kuala Lumpur
50672
Malaysia
"ROR" |
https://ror.org/00jsvb253 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
