Open Label Study to Evaluate the Effect of Kaempferia Parviflora in Support of Erectile Function and Male Sexual Health
NCT ID: NCT03389867
Last Updated: 2018-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
14 participants
INTERVENTIONAL
2014-06-30
2016-03-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effects of a Nitrate Supplementation on Erectile Function
NCT06213077
Effect of Udenafil on Spermatogenesis
NCT01230541
Treatment of Erectile Dysfunction - Long Term Safety and Efficacy
NCT01065012
Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men
NCT06571318
The Impact of Dietary Pattern on Erectile Function
NCT04349059
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Male Sexual Health Formulation
Kaempferia parviflora extract 100mg daily
Kaempferia parviflora extract
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Kaempferia parviflora extract
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Exclusion Criteria
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
50 Years
70 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Supplement Formulators, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steven Joyal
Role: PRINCIPAL_INVESTIGATOR
Life Extension
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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. doi: 10.1016/j.chroma.2007.01.033. 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. doi: 10.1016/j.jep.2006.09.037. 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
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.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CL073
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.