Open Label Study to Evaluate the Effect of Kaempferia Parviflora in Support of Erectile Function and Male Sexual Health

Primary Inclusion Criteria:

1. Healthy male volunteers between the age of 50-70 inclusive

2. Having been (or attempted to be) sexually active for at least the last 6 months

3. Having been in a stable sexual relationship for the past 6 months or more

4. Be able to comply with a 14-day washout period of all sexual performance enhancing
medications, nutritional supplements or herbs prior to Day 1 randomization

5. Be able to comply with a 14-day washout period of all nutritional supplements that
may contain any of the components of the formulation prior to Day 1 enrollment

Primary Exclusion Criteria:

1. Having a Body Mass Index greater than 34.9

2. Currently receiving or having received treatment in the past 6 months for any sexual
disorder or dysfunction (including treatment for erectile function, intercourse
satisfaction, orgasmic function, or sexual desire)

3. Attain a score of < 16 on the IIEF-5 questionnaire

4. Primary diagnosis of another sexual disorder (e.g., premature ejaculation)

5. Currently taking supplements including Kaempferia parviflora, DHEA
(Dehydroepiandrosterone), chrysin, pregnenolone, grape seed extract, bitter orange,
country mallow, ephedra, bitter melon, catuaba, horny goat weed, mucuna pruriens,
maca, tribulus terrestris, muira puama, yohimbe or sativa, fenugreek, tongkat ali,
Activali, Eurycoma longifolia Jack and goat's rue or any other supplement which has
effects on sexual health. Also, testosterone and aromatase inhibitors (letrozole,
anastrozole, exemestane, tesolactone) and phosphodiesterase type 5 inhibitors (e.g.
sildenafil, tadalafil, vardenafil) unless willing to washout 14 days prior to
baseline

6. Having any of the following disorders: benign prostatic hyperplasia (BPH), diabetes
mellitus, cancer (including prostate and male breast cancer), insomnia, sleep apnea,
heart disease, hypertension, renal disease, liver disease, vascular disease,
endocrine abnormalities (e.g. hypogonadism or hypo/hyperthyroidism), multiple
sclerosis, psychiatric disorder, acute genitourinary disorder, history of spinal
cord injury, herniated disc, penile injury or disease (e.g. Peyronie's disease,
priapism or genital anatomic abnormalities) or any other significant medical or
surgical procedure that precludes participation in the judgment of the
investigator/sub-investigator

7. Currently taking medications for benign prostatic hyperplasia (e.g. tamsulosin,
dutasteride, finasteride, terazosin), theophylline medications, antihypertensive
medications (e.g. diuretics, sympatholytics, beta blockers, calcium channel
blockers), antidiabetic medications, psychiatric medications (e.g. antipsychotic
agents, antidepressants, or anxiolytic agents), androgenic and antiandrogenic
medications, digitalis, histamine H2-receptor blockers, ketoconazole, niacin, MAOI
(monoamine oxidase inhibitor) (e.g. phenelzine), phenobarbital, phenytoin,
anticoagulants (e.g. warfarin, high dose aspirin, cilostazol [Pletal], clopidogrel
[Plavix], dalteparin [Fragmin], enoxaparin [Lovenox], heparin, ticlopidine [Ticlid])
or receiving nitrate therapy -

8. Laboratory: bilirubin > 2 x ULN (Upper limit of normal) , AST/SGOT (aspartate
aminotransferase/serum glutamic oxaloacetic transaminase) and ALT/SGPT (alanine
aminotransferase/serum glutamic pyruvic transaminase) ( > 2 x ULN, serum creatinine
> 1.5 mg/dL, total cholesterol > 347.9mg/dl, triglycerides > 300mg/dl, and PSA > 4
ng/mL