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

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

Detailed Description
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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.

Official Title
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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.

Conditions
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Erectile Function

Intervention / Treatment
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* Dietary Supplement: Kaempferia parviflora extract


Participation Criteria
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Eligibility Criteria
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Primary Inclusion Criteria: Healthy male volunteers between the age of 50-70 inclusive Having been (or attempted to be) sexually active for at least the last 6 months Having been in a stable sexual relationship for the past 6 months or more 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 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: Having a Body Mass Index greater than 34.9 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) Attain a score of < 16 on the IIEF-5 questionnaire Primary diagnosis of another sexual disorder (e.g., premature ejaculation) 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 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 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 - 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Male Sexual Health Formulation<br>Kaempferia parviflora extract 100mg daily | Dietary Supplement: Kaempferia parviflora extract<br> <br> * Other names: KaempMax™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF (International Index of Erectile Dysfunction) questionnaire scores | Mean change in IIEF scores. There are five specific areas addressed including Erectile Function (questions:1-5 & 15;score range: 0-5, maximum score:30); Orgasmic Function (questions:9-10; score range:0-5; maximum score:10); Sexual desire (questions:11-12; score range:1-5; maximum score:10); Intercourse satisfaction (questions:6-8; score range:0-5; maximum score:15); Overall satisfaction (questions:13-14; score range:1-5; maximum score:10). The lower the score represents greater dysfunction within each domain. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GAQ (Global Assessment Question) | Response (yes or no) from Global Assessment Question | 30 days | 
| Levels of Free Testosterone | Mean change in Free Testosterone levels in pg/ml | 30 days | 
| Levels of Total Testosterone | Mean change in Total Testosterone levels in ng/dl | 30 days | 
| Levels of Estradiol | Mean change in Estradiol levels in pg/ml | 30 days | 
| Levels of DHEA-S | Mean change in DHEA-S levels in ug/dl | 30 days | 
| Levels of PSA | Mean change in PSA levels in ng/ml | 30 days | 
| Levels of Total Cholesterol | Mean change in Total Cholesterol levels in mg/dl | 30 days | 
| Levels of LDL Cholesterol | Mean change in LDL Cholesterol levels in mg/dl | 30 days | 
| Levels of HDL Cholesterol | Mean change in HDL Cholesterol levels in mg/dl | 30 days | 
| Levels of Triglycerides | Mean change in Triglyceride levels in mg/dl | 30 days | 
| Body Mass Index | Mean change in body mass index in kg/m^2 calculated by formula using the body weight (lb.) and the height (in.) | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male sexual health, Erectile function