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  • Wayal®Poten5X™


    DIETARY SUPPLEMENT

    ----------

    Wayal®
    Poten5X™

    Dietary Supplement

    • Support Male Stamina1
    • Support Sexual Arousal1

    1
    These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

    Contains

    30 Vegetarian Capsules (500mg each) per box

    Suggested Use

    Adults: Take two (2) 500 mg capsules daily with meals as a dietary supplement or as directed by your healthcare professional.

    Supplement Facts

    Wayal® Poten5X™

    Wayal® Poten5X™ Formulation provide psychological and biological contribution by multi-target formulation of herbal ingredients having scientifically standardized high flavonoids and total saponins by

    1. Cynara cardunculus extract
    2. Trigonella foenum graecum extract
    3. Withania somnifera extract
    4. Mucuna pruriens extract
    5. L-arginine

    in appropriate proportion and expected to have a synergistic action in the management of Erectile dysfunction (ED) , Premature ejaculation (PE) and loss of control of erection and ejaculation (LCEE) with high safety profile in a eight (8) weeks double-blind, placebo-controlled, randomized study by medical center. Wayal® Poten5X™ Formulation exerts its activity by managing the stress and anxiety, the testosterone levels, NO levels, and neurotransmitters (dopamine and serotonin) involved in the management of ED, PE and LCEE.

    The oral LD50 of Wayal® Poten5X™ Formulation in rats was found to be >5000mg/kg body weight. No clinical signs of toxicity and mortalities were observed at tested dose in any of the dosed animals.

    Warning

    KEEP OUT OF THE REACH OF CHILDREN.

    DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

    Caution

    Before using any dietary supplement, pregnant or lactating women should consult with a physician or healthcare professional.

    Storage

    Store between 15°-30°C (59°-86°F).

    Free of:

    Milk, egg, fish, shellfish, tree nuts, wheat, peanut and soybeans.

    NON-GMO, GLUTEN FREE, SOY FREE

    Other Ingredients

    Capsules (Hypromellose, Titanium Dioxide), MCC (Microcrystalline cellulose), Silica

    Poten5X™

    2022/01/07, Nature published a systematic review of Erectile dysfunction (ED) prevalence during COVID-19 pandemic, the prevalence of ED ranged from 32% to 87%. Premature Ejaculation (PE) occurs in about 30% to 75% of men in some reviews. And it becomes the most common sexual disorder in the male population. The new taxonomic entity called loss of control of erection and ejaculation (LCEE) views the two sexual symptoms as deeply interrelated.

    However, physical treatments, psychological treatments, oral medications, surgery, or even penis injection need to rule out a huge populations, and to evaluate these severe contraindications, warnings, precautions, adverse reactions, and drug interactions to avoid cardiovascular threats, vision damage, hearing disorders, abnormal blood pressure, and even skin cancer caused by the treatment or common medications or even juice.

    Poten5X™ Formulation provides the high safety and reliable efficacy profile herbal ingredients formula with statistical tested significant, proved by a peer-review randomized double-blind placebo-control clinical study that conducted in compliance with International Conference on Harmonization- Good Clinical Practice (ICH-GCP) guideline, and approved by the Ethics Committee of a famous medical center.

    Poten5X™ Formulation at a dose of 500 mg twice per day was trialed for its ability to support male stamina, in a double-blind, placebo-controlled, randomized study of 60-otherwise healthy, monogamous men, aged 21 to 60. At visit 1st (4 weeks) and visit 2nd (8 weeks), 29 men in the treatment group and 28 in the placebo group were assessed for changes in efficacy and safety parameters from baseline.

    • Primary endpoint was the intravaginal ejaculation time (IELT). Baseline values for all 57 men that completed the study included an IELT < 2 mins.
    • Secondary endpoints included individual and mean scoring of the 4 elements of the Premature Ejaculation Profile (PEP) score:
      1. Control of ejaculation
      2. Distress
      3. Satisfaction
      4. Interpersonal difficulty
      IELT changes were significantly improved (p<0.05) in the Poten5X™ Formulation group alone, as early as 4-weeks into the study, while an overall more than 5-fold increase (p<0.05) in IELT scores were found in the Poten5X™ Formulation group, over placebo at 8 weeks.
    • Clinical Global Impression-Improvement scale (CGI-I) indicates the significant improvement of Much Improve scale of the Poten5X™ Formulation group is from 6.67% (4 weeks) to 83.33% (8 weeks) whereas 0% and 0% respectively for placebo group.
    • The reported adverse events in
      • Poten5X™ Formulation group: constipation 2 (6.67%) and fatigue 1 (3.33%).
      • Placebo group: constipation 1 (3.33%), fatigue 1 (6.67%), and fever 2 (6.67%).
    • No remarkable changes were observed in
      1. Laboratory parameters
      2. Vital signs (heart rate, blood pressure, etc.)
      3. Physical examinations
      4. Systemic examinations

    Cynara cardunculus extract

    Artichoke (Cynara cardunculus) was consumed as a food and used medicinally by ancient people for millenniums.

    • Much of the pharmacologic activity of the Artichoke leaves has been attributed to the presence of
      1. Polyphenolic compounds such as caffeoylquinic acid derivatives
      2. Mono- and di-caffeoylquinic acids, including chlorogenic, neochlorogenic, cryptochlorogenic acids
      3. Luteolin
      4. Cynarin
    • Artichoke thereby delivered researches published on the effect of:
      1. Cardiovascular effects Mocelin 2016, Ben Salem 2017, Bogavac-Stanojevic 2018, Rondanelli 2013
      2. Anti-oxidant activity Colak 2016, El-Boshy 2017, El Morsy 2015, Heidarian 2013, Skarpanska-Stejnborn 2008
      3. Erectile dysfunction (ED) treatment: inhibit phosphodiesterase-5 (PDE5) Singh 2011
      4. Diabetes/Glucose-lowering effects Ben Salem 2017, Ebrahimi-Mameghani 2018
      5. Liver protection Elsebai 2015, Tang 2017, Panahi 2018, Rangboo 2016
      6. Anti-inflammatory effects Ben Salem 2017
      7. Renal protection Khattab 2016, Panahi 2018
      8. Anti-microbial activity Pereira 2016
      9. Anti-Cancer da Silva 2017, Russo 2017
      10. Chemotherapy-induced toxicity Mustafa 2015
      11. Dermatological effects Tanaka 2013
      12. GI effects L azzini 2016, Riezzo 2012
      13. Artichoke may inhibit various CYP-450 isoenzymes, although the mechanism is not fully understood Campos 2018, Elsebai 2016

    Trigonella foenum graecum extract

    Fenugreek (Trigonella foenum-graecum ) is used extensively in various parts of the world as herb, food, spice, and traditional medicine, one of the oldest medicinal plants and its health-promoting effects have been cited in Ayurveda and traditional Chinese medicine. Fenugreek is also "generally recognized as safe" (GRAS) as a flavoring by the U.S. Food and Drug Administration.

    • The phytochemical analysis of Fenugreek reveals the presence of steroids, alkaloids, saponins, polyphenols, flavonoids, lipids, carbohydrates, amino acids, and hydrocarbons.
    • The fenugreek seeds contain saponins and sapogenins, which are responsible for increasing sex hormones, testosterone level, libido, and improvement in LCEE. Studies found that fenugreek extract had a significant influence on sexual arousal, energy, and stamina, and helped participants maintain a normal testosterone level.
    • Extensive preclinical and clinical researches have outlined the pharmaceutical uses of fenugreek as:
      1. Antidiabetic
      2. Anti-hyperlipidemia
      3. Anti-obesity
      4. Anticancer
      5. Anti-inflammatory
      6. Antioxidant
      7. Antifungal
      8. Antibacterial
      9. Galactagogue
      10. Improving women's health
      11. ED, PE and LCEE management
      12. Improve semen quality for late-fertility management
    • Fenugreek interacts with warfarin to cause bleeding
    • Caution should be used in giving high dosages to women with diabetes mellitus or those taking warfarin.

    Withania somnifera extract

    The ashwagandha (Withania somnifera) is one of the most famous herbs of Ayurveda in Asia for centuries and listed in the pharmacopoeia of many countries, and wins the nutrition industry award recently with significant effects on both psychological and physiological aspects of human functioning.

    • The Health department of Canada government reviews ashwagandha statement(s) to the effect of:
      1. Traditionally used in Ayurveda to relieve general debility, especially during convalescence or old age Sukh Dev 2005, API 2001, Upton 1999
      2. Used in Herbal Medicine as an adaptogen to help increase energy and resistance to stress (e.g. in case of mental and physical fatigue related to stress).
      3. Traditionally used in Ayurveda as Rasayana (rejuvenative tonic) API 2001, Kapoor 2001
      4. Traditionally used in Ayurveda for memory enhancement Khare 2004, Upton 2000
      5. Traditionally used in Ayurveda as a sleep aid Kapoor 2001, Khory and Katrak 1999[1903], Nadkarni and Nadkarni 1954
      6. Traditionally used in Ayurveda to balance aggravated Vata. Upton 2000, Nadkarni and Nadkarni 1954
    • Recent researches of ashwagandha are most on:
      1. Reduce stress and anxiety
      2. Enhance cardiorespiratory endurance
      3. Promote muscle strength, size and recovery
      4. Maintain healthy testosterone in men
      5. Promote sexual function in both genders and increase fertility
      6. Maintain normal thyroid and lowers blood sugar and fat
      7. Enhance memory and cognition
      8. Support healthy weight management

    Wayal® choose Ashwagandha extract that owns professional technologies to standardized powerful steroidal alkaloids and steroidal lactone of Ashwagandha to have high performance liquid chromatography (HPLC) processed special concentration with anolides, to be one active ingredient of Wayal® Poten5X™ to provide reliable healthy contributions and irreplaceable high safety.

    Mucuna pruriens extract

    The Mucuna pruriens seeds contain a vast range of phytochemical constituents such as

    • Alkaloids
    • Glycosides
    • Saponins
    • Reducing sugars
    • Tannins
    • L-Dopa (3, 4-dihydroxy-l-phenylalanine, a precursor for neurotransmitter dopamine involved in mood and sexuality. Dopamine stimulates hypothalamus leading to the secretion of gonadotropin releasing hormone, which in turn leads to the stimulation of pituitary gland to secrete follicle stimulating hormone (FSH) and luteinizing hormone (LH) to trigger increased production of testosterone, which is essential for libido. The L-DOPA has well-established aphrodisiac properties and are known to boost the testosterone, LH, dopamine, adrenaline, and noradrenaline levels was observed in infertile men with reduced levels of FSH and prolactin. Mucuna pruriens seeds were extracted by special technology to achieve the high efficacy concentration with high safety profile, and was used in Poten5X™ formulation.
    • Mucuna pruriens is considered as a future restorative herb because of its published activities, such as
      1. Anti-cholesterolemic
      2. Anti-Parkinson
      3. Anti-oxidan
      4. Anti-diabetic
      5. Sexual Enhancing
      6. Anti-inflammatory
      7. Anti-microbial
      8. Anti-venom
      9. Anticancer activities
      10. Parkinson's disease management
    • Mucuna pruriens is poisonous when ingested by ruminants.

    L-arginine

    L-arginine is an amino acid involved in many important bio-chemical reactions, including NO synthesis in the body or helps our body build protein. L-arginine can produced by our own or intake from most protein-rich foods, including fish, red meat, beans, soy, poultry whole grains, and dairy products.

    L-arginine is considered to be generally safe. It might be effective at lowering blood pressure, reducing the symptoms of angina and PAD, and treating erectile dysfunction (ED) by physical cause as PDE5 inhibitor

    • L-arginine research on the use of L-arginine on:
      1. Angina
      2. High blood pressure (hypertension)
      3. High blood pressure during pregnancy
      4. Preeclampsia
      5. Erectile dysfunction by physical cause
      6. Peripheral arterial disease (PAD)
    • L-arginine is NOT recommended for:
      1. Recent heart attack
      2. Allergies or asthma
      3. Cold sores or genital herpes
    • L-arginine possible Drug interactions including:
      • Anticoagulants and anti-platelet drugs, herbs and supplements
      • Blood pressure drugs, herbs and supplements
      • Diabetes drugs, herbs and supplements
      • Isoproterenol (Isuprel)
      • Nitrate
      • Water pills (potassium-sparing diuretics)
      • Sildenafil (such as Viagra)

    Poten5X™

    • Support Male Stamina1
    • Support Sexual Arousal1

    • Ingredients

    Wayal® Poten5X™ choose key active herbs to be extract by advanced professional technologies to standardized powerful ingredients, even using high performance liquid chromatography (HPLC) processed to provide reliable healthy contributions and irreplaceable high safety.

    • Formulation

    Wayal® Poten5X™ Formulation provides psychological and biological health contribution by multi-target formulation of five (5) herbal ingredients having scientifically standardized high efficacy purity in appropriate proportion.

    • Clinical Study

    Wayal® Poten5X™ Formulation provides the high safety and reliable efficacy profile herbal ingredients formula with statistical tested significant, proved by a peer-review randomized double-blind placebo-controlled human clinical study that conducted in compliance with International Conference on Harmonization- Good Clinical Practice (ICH-GCP) guideline, and approved by the Ethics Committee of a famous medical center.

    • FAQ

    Q: How did the formulation for Poten5X come together, i.e. what was it based upon?
    A: Poten5X was inspired by the wisdom of the Ayurveda medical tradition, formulated to be both nourishing and balancing to a variety of systems, but with a synergistic emphasis on hormonal, neuronal and vascular functions.

    Q: What are the actives in Poten5X? Poten5X contains many active molecules, but its unique formulation lends to a composite standard for saponins and flavonoids, which maintains the exclusive fingerprint for the blend. Q: Why are extracts used in Poten5X and not powders?

    A. Extracts are used in Poten5X so that the most active principles, those known to contribute to the biological effects of the individual herbs can be optimized in terms of concentration and quality.

    Q: Is Poten5X clinically-studied?
    A. Yes – Poten5X has been subjected to a double-blind, placebo-controlled, randomized clinical study over the course of 8 weeks in 60 healthy men, age 18-60 years old experiencing reduced sexual stamina. The study has been completed and published results are expected soon.

    Q: Are there any safety studies on Poten5X?
    A. Not specifically, but safety parameters were evaluated for the ingredient during the 56-day clinical study and no significant changes were noted in vital signs or blood, serum or urine markers. There was no difference in mild side effects, of constipation and fatigue between the p and placebo groups.

    Q: What is the clinical dose for Poten5X?
    A. The clinically studied dose of Poten5X for supporting male sexual stamina is 500 mg, 2x per day.

    Q: How soon can results be noticed?
    A. In the clinical study, results were seen in as early as 4-weeks, but results were progressively better with continued use into the 8th week. No further data is available beyond 8-weeks.

    Q: Will Poten5X increase testosterone, or any other hormone levels?
    A. We do not have data on this at this time, however we hope to evaluate this at a future time.

    Q: Can women use Poten5X?
    A. In theory, yes – because the individual components of this formulation have been used by both genders, however we only have clinical evidence at this time for Poten5X use in males for the support of sexual stamina.

    Reference

    1. Bakr, 2022

    2. El-Hamd MA, 2019

    3. Crowdis M, 2021

    5. https://www.pfizer.com/products/product-detail/viagra

    6. https://labeling.pfizer.com/ShowLabeling.aspx?id=652#section-7

    7. https://www.lillymedical.com/en-us/mens-health/cialis

    8. https://uspl.lilly.com/cialis/cialis.html#pi

    9. https://www.bayer.com/sites/default/files/br-levitra-englisch.pdf

    10. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Levitra/pdf/LEVITRA_PI.PDF#page=24

    11. https://www.bayer.com/sites/default/files/br-levitra-englisch.pdf

    12. https://www.medicines.org.uk/emc/product/1269/smpc#gref

    13. https://www.medicines.org.uk/emc/files/pil.1269.pdf

    14. JAMA Intern Med. 2014

    15. https://www.webmd.com

    16. Maheshwari A, 2017

    17. Andersson KE, 2018

    18. Yu MC, 2010

    19. Kalyan C Nagulapalli Venkata 2017

    20. Nasibeh Roozbeh 2021

    21. Health Canada http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monoReq.do?id=35

    22. https://ksm66ashwagandhaa.com

    23. https://www.forbes.com

    24. Shukla KK, 2009

    25. Kavitha C, Thangamani C, 2014

    26. Shukla KK, 2010

    27. Steels E, 2011

    28. Chauhan NS, 2014

    29. Ruhi Pathania , 2020

    30. Waldinger, 2003

    31. https://www.mayoclinic.org/drugs-supplements-l-arginine/art-20364681

    Manufactured and Distributed By

    Manufactured in a cGMP certified U.S.A. Facility.
    Wayal®
    U.S.A.
    +1 626-986-4598
    www.wayal.com

    PRODUCT PHOTO

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    The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected over dosage, the drug's identity should be verified by chemical analysis.

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