Clinical trial NCT03389867: Open Label Study to Evaluate the Effect of Kaempferia Parviflora in Support of Erectile Function and Male Sexual Health
Official title: An Open Label Study to Evaluate the Effect of Kaempferia Parviflora in Support of Erectile Function and Male Sexual Health Among Overall Healthy Males 50-70.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Function
Keywords: Male sexual health
Erectile function
Lead sponsor: Supplement Formulators, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-04
Enrollment: 14
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to evaluate the overall efficacy and safety of Kaempferia parviflora in overall healthy male human subjects.

Detailed description: This study was an open label safety and efficacy study. Each subject received a specific dose of a formulation containing Kaempferia parviflora. There would be attempted telephone or e-mail contact in 2 weeks following enrollment.

Participants would undergo assessments of blood tests, vital signs, body weight with completion of questionnaires.

The primary objective was to assess the effect of Kaempferia parviflora on erectile function among overall healthy males age 50 to 70.

Eligibility criteria: 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

Primary outcomes:
measure: IIEF (International Index of Erectile Dysfunction) questionnaire scores
timeFrame: 30 days
Secondary outcomes:
measure: GAQ (Global Assessment Question)
timeFrame: 30 days
measure: Levels of Free Testosterone
timeFrame: 30 days
measure: Levels of Total Testosterone
timeFrame: 30 days
measure: Levels of Estradiol
timeFrame: 30 days
measure: Levels of DHEA-S
timeFrame: 30 days
measure: Levels of PSA
timeFrame: 30 days
measure: Levels of Total Cholesterol
timeFrame: 30 days
measure: Levels of LDL Cholesterol
timeFrame: 30 days
measure: Levels of HDL Cholesterol
timeFrame: 30 days
measure: Levels of Triglycerides
timeFrame: 30 days
measure: Body Mass Index
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Life Extension
name: Steven Joyal
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Wannanon P, Wattanathorn J, Tong-Un T et al. Efficacy Asssessment of Kaempferia Parviflora for the Management of Erectile Dysfunction. OnLine Journal of Biological Sciences. 12 (4), 149-155, 2012
citation: Wattanapitayakul SK, Suwatronnakorn M, Chularojmontri L, Herunsalee A, Niumsakul S, Charuchongkolwongse S, Chansuvanich N. Kaempferia parviflora ethanolic extract promoted nitric oxide production in human umbilical vein endothelial cells. J Ethnopharmacol. 2007 Apr 4;110(3):559-62. doi: 10.1016/j.jep.2006.09.037. Epub 2006 Oct 13.
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citation: Stein RA, Schmid K, Bolivar J, Swick AG, Joyal SV, Hirsh SP. Kaempferia parviflora ethanol extract improves self-assessed sexual health in men: a pilot study. J Integr Med. 2018 Jul;16(4):249-254. doi: 10.1016/j.joim.2018.05.005. Epub 2018 May 26.