NCT03389867

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
Last Updated

January 4, 2018

Status Verified

December 1, 2017

Enrollment Period

1.4 years

First QC Date

December 5, 2017

Last Update Submit

December 26, 2017

Conditions

Erectile Function

Keywords

Male sexual healthErectile function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • GAQ (Global Assessment Question)

    30 days

  • Levels of Free Testosterone

    30 days

  • Levels of Total Testosterone

    30 days

  • Levels of Estradiol

    30 days

  • Levels of DHEA-S

    30 days

  • +6 more secondary outcomes

Study Arms (1)

Male Sexual Health Formulation

EXPERIMENTAL

Kaempferia parviflora extract 100mg daily

Dietary Supplement: Kaempferia parviflora extract

Interventions

Kaempferia parviflora extractDIETARY_SUPPLEMENT
Also known as: KaempMax™
Male Sexual Health Formulation

Eligibility Criteria

Age50 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Ayta IA, McKinlay JB, Krane RJ. The likely worldwide increase in erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJU Int. 1999 Jul;84(1):50-6. doi: 10.1046/j.1464-410x.1999.00142.x.

    PMID: 10444124BACKGROUND

  • Chivapat S, Chavalittumrong P, Attawish A et al. Chronic Toxicity Study of Kaempferia parviflora Wall ex. Extract. Thai J Vet. Med. 40(4):377-383, 2010.

    BACKGROUND

  • . Report from Tokiwa Phytochemical Co. LTD. Sirtmax® PCT/JP2012/084000.

    BACKGROUND

  • Shabsigh R, Anastasiadis AG. Erectile dysfunction. Annu Rev Med. 2003;54:153-68. doi: 10.1146/annurev.med.54.101601.152212. Epub 2002 Aug 19.

    PMID: 12525671BACKGROUND

  • Sudwan P, Saenphet K, Saenphet S, Suwansirikul S. Effect of Kaempferia parviflora Wall. ex. Baker on sexual activity of male rats and its toxicity. Southeast Asian J Trop Med Public Health. 2006;37 Suppl 3:210-5.

    PMID: 17547083BACKGROUND

  • Sutthanut K, Sripanidkulchai B, Yenjai C, Jay M. Simultaneous identification and quantitation of 11 flavonoid constituents in Kaempferia parviflora by gas chromatography. J Chromatogr A. 2007 Mar 2;1143(1-2):227-33. doi: 10.1016/j.chroma.2007.01.033. Epub 2007 Jan 13.

    PMID: 17266972BACKGROUND

  • Tambi MI, Imran MK, Henkel RR. Standardised water-soluble extract of Eurycoma longifolia, Tongkat ali, as testosterone booster for managing men with late-onset hypogonadism? Andrologia. 2012 May;44 Suppl 1:226-30. doi: 10.1111/j.1439-0272.2011.01168.x. Epub 2011 Jun 15.

    PMID: 21671978BACKGROUND

  • Tep-Areenan P, Sawasdee P, Randall M. Possible mechanisms of vasorelaxation for 5,7-dimethoxyflavone from Kaempferia parviflora in the rat aorta. Phytother Res. 2010 Oct;24(10):1520-5. doi: 10.1002/ptr.3164.

    PMID: 20878704BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 17113256BACKGROUND

  • Wattanathorn J, Muchimapura S, Tong-Un T, Saenghong N, Thukhum-Mee W, Sripanidkulchai B. Positive Modulation Effect of 8-Week Consumption of Kaempferia parviflora on Health-Related Physical Fitness and Oxidative Status in Healthy Elderly Volunteers. Evid Based Complement Alternat Med. 2012;2012:732816. doi: 10.1155/2012/732816. Epub 2012 Jul 31.

    PMID: 22899957BACKGROUND

  • Wattanathorn J, Pangphukiew P, Muchimapura S et al Aphrodisiac Activity of Kaempferia parviflora. American Journal of Agricultural and Biological Sciences. 7(2);114-120, 2012

    BACKGROUND

  • 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.

    PMID: 29880257DERIVED

Related Links

Study Officials

  • Steven Joyal

    Life Extension

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2017

First Posted

January 4, 2018

Study Start

June 30, 2014

Primary Completion

November 29, 2015

Study Completion

March 15, 2016

Last Updated

January 4, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share