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Erectile FunctionNCT03389867

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

A study testing Kaempferia parviflora extract in people with Erectile Function, run by Supplement Formulators, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 50 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for
Erectile Function
What is being tested?
Kaempferia parviflora extract
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
No sites listed yet
Study dates
30 Jun 2014to 15 Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

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

About this study

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.

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

Read the 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.

Being tested
Kaempferia parviflora extract
Keywords
Male sexual health, Erectile function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kaempferia parviflora extractDietary supplement

    Also called KaempMax™

Study groups in NCT03389867
Study groupRoleWhat they receive
Male Sexual Health FormulationExperimentalKaempferia parviflora extract 100mg daily
Receives: Dietary Supplement: Kaempferia parviflora extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 days

Secondary outcomes (11)

  1. GAQ (Global Assessment Question)

    Response (yes or no) from Global Assessment Question

    Measured: 30 days

  2. Levels of Free Testosterone

    Mean change in Free Testosterone levels in pg/ml

    Measured: 30 days

  3. Levels of Total Testosterone

    Mean change in Total Testosterone levels in ng/dl

    Measured: 30 days

  4. Levels of Estradiol

    Mean change in Estradiol levels in pg/ml

    Measured: 30 days

  5. Levels of DHEA-S

    Mean change in DHEA-S levels in ug/dl

    Measured: 30 days

  6. Levels of PSA

    Mean change in PSA levels in ng/ml

    Measured: 30 days

  7. Levels of Total Cholesterol

    Mean change in Total Cholesterol levels in mg/dl

    Measured: 30 days

  8. Levels of LDL Cholesterol

    Mean change in LDL Cholesterol levels in mg/dl

    Measured: 30 days

  9. Levels of HDL Cholesterol

    Mean change in HDL Cholesterol levels in mg/dl

    Measured: 30 days

  10. Levels of Triglycerides

    Mean change in Triglyceride levels in mg/dl

    Measured: 30 days

  11. 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.)

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2018
  2. Study start30 Jun 2014
  3. Primary completion29 Nov 2015
  4. Study completion15 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03389867
Sponsor's protocol ID
CL073
Status last verified
Dec 2017
First submitted
5 Dec 2017
Last updated
4 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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. doi: 10.1046/j.1464-410x.1999.00142.x.

    PubMed 10444124

  • 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. doi: 10.1146/annurev.med.54.101601.152212. Epub 2002 Aug 19.

    PubMed 12525671

  • 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.

    PubMed 17547083

  • 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.

    PubMed 17266972

  • 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.

    PubMed 21671978

  • 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.

    PubMed 20878704

  • 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. doi: 10.1016/j.jep.2006.09.037. Epub 2006 Oct 13.

    PubMed 17113256

  • 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.

    PubMed 22899957

  • 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

  • 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.

    PubMed 29880257

Questions about this trial

What is this clinical trial studying?

A study testing Kaempferia parviflora extract in people with Erectile Function, run by Supplement Formulators, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IIEF (International Index of Erectile Dysfunction) questionnaire scores (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03389867, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2018.

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