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

• ClinicalTrials.gov Identifier: NCT03389867
• Recruitment Status: Completed
• First Posted: January 4, 2018
• Last Update Posted: January 4, 2018
• Sponsor: Supplement Formulators, Inc.
• Information provided by (Responsible Party): Supplement Formulators, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Erectile Function	Dietary Supplement: Kaempferia parviflora extract	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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.
• Actual Study Start Date: June 30, 2014
• Actual Primary Completion Date: November 29, 2015
• Actual Study Completion Date: March 15, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Male Sexual Health Formulation; Kaempferia parviflora extract 100mg daily	Dietary Supplement: Kaempferia parviflora extract; Other Name: KaempMax™

Outcome Measures

Primary Outcome Measures :

1. IIEF (International Index of Erectile Dysfunction) questionnaire scores [ Time Frame: 30 days ]
   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.

Secondary Outcome Measures :

1. GAQ (Global Assessment Question) [ Time Frame: 30 days ]
   Response (yes or no) from Global Assessment Question
2. Levels of Free Testosterone [ Time Frame: 30 days ]
   Mean change in Free Testosterone levels in pg/ml
3. Levels of Total Testosterone [ Time Frame: 30 days ]
   Mean change in Total Testosterone levels in ng/dl
4. Levels of Estradiol [ Time Frame: 30 days ]
   Mean change in Estradiol levels in pg/ml
5. Levels of DHEA-S [ Time Frame: 30 days ]
   Mean change in DHEA-S levels in ug/dl
6. Levels of PSA [ Time Frame: 30 days ]
   Mean change in PSA levels in ng/ml
7. Levels of Total Cholesterol [ Time Frame: 30 days ]
   Mean change in Total Cholesterol levels in mg/dl
8. Levels of LDL Cholesterol [ Time Frame: 30 days ]
   Mean change in LDL Cholesterol levels in mg/dl
9. Levels of HDL Cholesterol [ Time Frame: 30 days ]
   Mean change in HDL Cholesterol levels in mg/dl
10. Levels of Triglycerides [ Time Frame: 30 days ]
    Mean change in Triglyceride levels in mg/dl
11. Body Mass Index [ Time Frame: 30 days ]
    Mean change in body mass index in kg/m^2 calculated by formula using the body weight (lb.) and the height (in.)

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Sponsors and Collaborators

Supplement Formulators, Inc.

Investigators

• Principal Investigator: Steven Joyal; Life Extension

More Information

Additional Information:

Kaempferia parviflora 

Publications:

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.

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.

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

Shabsigh R, Anastasiadis AG. Erectile dysfunction. Annu Rev Med. 2003;54:153-68. Epub 2002 Aug 19. Review.

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.

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. Epub 2007 Jan 13.

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.

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.

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

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. Epub 2006 Oct 13.

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.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Supplement Formulators, Inc.
• ClinicalTrials.gov Identifier: NCT03389867
• Other Study ID Numbers: CL073
• First Posted: January 4, 2018
• Last Update Posted: January 4, 2018
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Supplement Formulators, Inc.:

Male sexual health; Erectile function