Protocol development in integrative medicine is not typically a simple process. Individuals require individualized care, and what works for one patient may not work for another.

To establish these protocols, we first developed a Rating Scale that could be used to discern the rigor of evidence supporting a specific nutrient’s therapeutic effect.

The following protocols were developed using only A through C-quality evidence.

Class
Qualifying studies
Minimum requirements
A
Systematic review or meta-analysis of human trials
 
B
RDBPC human trials
2+ studies and/or 1 study with 50 + subjects
C
RDBPC human trials
1 study

Introduction

As men age, concerns with sexual health arise. Erectile dysfunction (ED) is the inability to achieve or maintain an erection that is satisfactory for sexual intercourse. (Leslie 2024) Prevalence of ED increases with age—rates jump from 10% to 79% from the age of 40 to 80 years. Prevalence rates are even higher in individuals with comorbid conditions, particularly metabolic and cardiovascular diseases. (Pellegrino 2022) For example, the pooled estimated prevalence of ED among men with atrial fibrillation is 57%. (Chokesuwattanaskul 2018) Both type 1 and type 2 diabetes mellitus increase the likelihood of ED roughly 3.5-fold. (Kouidrat 2017)

Typical treatment of ED may consist of pharmaceutical interventions or psychological and behavioral interventions. (Burnett 2018)

The ingredients below have demonstrated efficacy in optimizing various aspects of male sexual health. Many of these effects are reflected in measures of sexual function and satisfaction assessed by the International Index of Erectile Function (IIEF), a questionnaire that evaluates sexual activity, intercourse, stimulation, ejaculation, and orgasm. (Rosen 1997)

Ingredients

Korean Ginseng (Panax ginseng)

Dosing: 1,000 mg 2–3 times daily for 8–12 weeks (de Andrade 2007)(Kim 2009)

Supporting evidence:

  • Ginsenosides, the active compounds in ginseng, protect vascular endothelium against oxidative injury and facilitate erections by inducing vasodilation and relaxation of the corpus cavernosum smooth muscle, primarily via nitric oxide (NO) release from endothelial cells and nerves. (Lee 2016) 
  • The authors of a meta-analysis reported that Panax ginseng may be effective for treating erectile dysfunction, as six randomized controlled trials (RCTs) that compared ginseng to placebo showed a significant benefit favoring ginseng (risk ratio = 2.40). (Jang 2008)
  • A systematic review and meta-analysis evaluating the clinical efficacy of herbal medicine in ED found that ginseng monopreparations significantly improved erectile function compared to placebo, as measured by the IIEF-5. (Borrelli 2018) 
Panax ginseng in the Fullscript catalog

Tribulus (Tribulus terrestris)

Dosing: 400–1,500 mg total per day in divided doses, for at least three months (Vilar Neto 2025)

Supporting evidence:

  • A systematic review and meta-analysis of 10 studies, including 483 men ages 16–70, concluded that Tribulus terrestris (TT), dosed at 400–750 mg per day for 1–3 months, improved ED in three of five studies that assessed this parameter. No significant effect was found for its ability to raise testosterone levels. (Vilar Neto 2025)
  • In an RCT with adult men with mild-to-moderate ED (n=172), TT led to significantly improved IIEF scores for intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction compared to placebo. (Kamenov 2017)
  • After three months of TT supplementation, men with ED and lower urinary tract symptoms (LUTS) showed statistically, but not clinically, significant increases in total testosterone levels, along with improvements in Arabic Index of Erectile Function scores. Notably, there were also small but statistically significant increases in mean aspartate transaminase (AST) and prostate-specific antigen (PSA) levels. However, LUTS did not worsen during the intervention. (GamalEl Din 2019)
Tribulus terrestris in the Fullscript catalog

Maca (Lepidium meyenii)

Dosing: 1.5–3 g per day for at least 12 weeks (Ulloa Del Carpio 2024) 

Supporting evidence:

  • In a randomized, double-blind, placebo-controlled trial, men aged 21–56 years who received maca (1,500 mg or 3,000 mg daily) reported increased sexual desire after eight weeks compared with those taking a placebo. This effect appeared independent of hormonal or mood changes, suggesting that other mechanisms may be involved and warrant further investigation. (Gonzales 2002) 
  • In a 12-week randomized, double-blind, placebo-controlled trial, 50 men with mild ED received either 2,400 mg/day of dry maca extract or placebo. Both groups showed improvements in IIEF-5 scores, but the maca group experienced significantly greater gains. (Zenico 2009)
  • In an RCT, researchers evaluated the efficacy of maca in treating symptoms of late-onset hypogonadism (LOH) among 80 men over the age of 40 with Aging Males’ Symptoms (AMS) questionnaire scores >27. Compared to those taking a placebo, maca-treated participants showed significant improvements in AMS total scores (−10.66), a reduction in positive screening rates for androgen deficiency based on the Androgen Deficiency in the Aging Males (ADAM) questionnaire (20.7% reduction relative to baseline), improved IIEF scores (14.00 ± 18.4), and significantly lower International Prostate Symptom Scores (IPSS) (−2.34 ± 4.65). (Shin 2023) 
Maca in the Fullscript catalog

Arginine

Dosing: 5 g one time per day for a minimum of six weeks (El Taieb 2019)

Supporting evidence:

  • A systematic review and meta-analysis of ten RCTs found that arginine supplementation, ranging from 1,500–5,000 mg daily, was associated with improvements in the IIEF subdomain scores of overall satisfaction, intercourse satisfaction, orgasmic function, and erectile function. (Rhim 2019)
  • L-arginine given as an adjunct to tadalafil improved IIEF scores and total testosterone levels compared to the single use of either in diabetic male patients with ED (n=108). (El Taieb 2019)
  • A prospective, randomized, multicenter trial of 300 men with ED also concluded that the combination of tadalafil with L-arginine is superior to either monotherapy for improving erectile function, especially in mild and severe ED categories. In the trial, 300 men received either L-arginine, tadalafil, or both daily for 12 weeks. The combination therapy group showed greater improvement in the IIEF-erectile function score (mean increase from 22.2 ± 2.2 to 29.3 ± 0.9) compared with the L-arginine (22.1 ± 2.2 to 27.5 ± 2.3)  and tadalafil (22.1 ± 2.2 to 27.8 ± 2) groups. (Gallo 2020)
Arginine in the Fullscript catalog

DHEA

*available in the US catalog

50 mg of DHEA for a minimum of 6 months (18)(19)

  • IIEF score increased in patients with ED when supplemented with 50 mg of DHEA for 6 months when compared to placebo (19)
  • All domains of IIEF improved in elderly men with ED supplemented with 50 mg of DHEA (18)

Ashwagandha (Withania somnifera)

Dosing: 300 mg twice daily for at least eight weeks ​​(Chauhan 2022)(Mutha 2025) 

Supporting evidence:

  • Ashwagandha supplementation may increase DHEA‑S and testosterone levels by approximately 18% and 14.7%, respectively, after 16 weeks, providing benefit to men with ED caused by androgen deficiency. (Lopresti 2019)(Wang 2024)
  • Compared to placebo, ashwagandha supplementation resulted in increased total Derogatis Interview for Sexual Functioning-Male (DISF-M) questionnaire scores and serum testosterone levels in an 8-week RCT with 50 male patients with low libido. (Chauhan 2022) 
  • In a prospective, double-blind, randomized, placebo-controlled study of 100 men aged 30–50, ashwagandha root extract enhanced sexual desire and satisfaction, as reflected by improvements in the Sexual Desire Inventory (SDI-2), the orgasm and sexual desire domains of the IIEF, and overall quality of life measured by the Short Form 12 (SF-12) questionnaire. (Mutha 2025) 

Disclaimer

The Fullscript Medical Advisory Team has developed or collected these protocols from practitioners and supplier partners to help health care practitioners make decisions when building treatment plans. By adding this protocol to your Fullscript template library, you understand and accept that the recommendations in the protocol are for initial guidance and may not be appropriate for every patient.

View protocol on Fullscript
References
  1. Borrelli, F., Colalto, C., Delfino, D. V., Iriti, M., & Izzo, A. A. (2018). Herbal dietary supplements for erectile dysfunction: A systematic review and meta-analysis. Drugs, 78(6), 643–673. https://doi.org/10.1007/s40265-018-0897-3
  2. Burnett, A. L., Nehra, A., Breau, R. H., Culkin, D. J., Faraday, M. M., Hakim, L. S., Heidelbaugh, J., Khera, M., McVary, K. T., Miner, M. M., Nelson, C. J., Sadeghi-Nejad, H., Seftel, A. D., & Shindel, A. W. (2018). Erectile dysfunction: AUA guideline. Journal of Urology, 200, 633. https://www.auanet.org/guidelines-and-quality/guidelines/erectile-dysfunction-(ed)-guideline
  3. Chauhan, S., Srivastava, M. K., & Pathak, A. K. (2022). Effect of standardized root extract of ashwagandha (Withania somnifera) on well‐being and sexual performance in adult males: A randomized controlled trial. Health Science Reports, 5(4), e741. https://doi.org/10.1002/hsr2.741
  4. Chokesuwattanaskul, R., Thongprayoon, C., Pachariyanon, P., Sharma, K., Ungprasert, P., Bathini, T., & Cheungpasitporn, W. (2018). Erectile dysfunction and atrial fibrillation: A systematic review and meta-analysis. International Journal of Urology, 25(8), 752–757. https://doi.org/10.1111/iju.13725
  5. de Andrade, E., de Mesquita, A. A., Claro, J. de A., de Andrade, P. M., Ortiz, V., Paranhos, M., & Srougi, M. (2007). Study of the efficacy of Korean Red Ginseng in the treatment of erectile dysfunction. Asian Journal of Andrology, 9(2), 241–244. https://doi.org/10.1111/j.1745-7262.2007.00210.x
  6. El Taieb, M., Hegazy, E., & Ibrahim, A. (2019). Daily oral l-arginine plus tadalafil in diabetic patients with erectile dysfunction: A double-blinded, randomized, controlled clinical trial. The Journal of Sexual Medicine, 16(9), 1390–1397. https://doi.org/10.1016/j.jsxm.2019.06.009
  7. El-Sakka, A. I. (2018). Dehydroepiandrosterone and erectile function: A review. The World Journal of Men’s Health, 36(3), 183–191. https://doi.org/10.5534/wjmh.180005
  8. Fujita, N., Okamoto, T., Yamamoto, H., Yoneyama, T., Hashimoto, Y., Mikami, T., Itoh, K., Ohyama, C., & Hatakeyama, S. (2024). Association between sex hormones and erectile dysfunction in men without hypoandrogenism. Scientific Reports, 14(1), 13433. https://doi.org/10.1038/s41598-024-64339-3
  9. Gallo, L., Pecoraro, S., Sarnacchiaro, P., Silvani, M., & Antonini, G. (2020). The daily therapy with L-arginine 2,500 mg and tadalafil 5 mg in combination and in monotherapy for the treatment of erectile dysfunction: A prospective, randomized multicentre study. Sexual Medicine, 8(2), 178–185. https://doi.org/10.1016/j.esxm.2020.02.003
  10. GamalEl Din, S. F., Abdel Salam, M. A., Mohamed, M. S., Ahmed, A. R., Motawaa, A. T., Saadeldin, O. A., & Elnabarway, R. R. (2018). Tribulus terrestris versus placebo in the treatment of erectile dysfunction and lower urinary tract symptoms in patients with late-onset hypogonadism: A placebo-controlled study. Urologia Journal, 86(2), 74–78. https://doi.org/10.1177/0391560318802160
  11. Gonzales, G. F., Cordova, A., Vega, K., Chung, A., Villena, A., Gonez, C., & Castillo, S. (2002). Effect of Lepidium meyenii (MACA) on sexual desire and its absent relationship with serum testosterone levels in adult healthy men. Andrologia, 34(6), 367–372. https://doi.org/10.1046/j.1439-0272.2002.00519.x
  12. Jang, D.-J., Lee, M. S., Shin, B.-C., Lee, Y.-C., & Ernst, E. (2008). Red ginseng for treating erectile dysfunction: A systematic review. British Journal of Clinical Pharmacology, 66(4), 444–450. https://doi.org/10.1111/j.1365-2125.2008.03236.x
  13. Kamenov, Z., Fileva, S., Kalinov, K., & Jannini, E. A. (2017). Evaluation of the efficacy and safety of Tribulus terrestris in male sexual dysfunction–A prospective, randomized, double-blind, placebo-controlled clinical trial. Maturitas, 99, 20–26. https://doi.org/10.1016/j.maturitas.2017.01.011
  14. Kim, T.-H., Jeon, S. H., Hahn, E.-J., Paek, K.-Y., Park, J. K., Youn, N. Y., & Lee, H.-L. (2009). Effects of tissue-cultured mountain ginseng (Panax ginseng CA Meyer) extract on male patients with erectile dysfunction. Asian Journal of Andrology, 11(3), 356–361. https://doi.org/10.1038/aja.2008.32
  15. Kouidrat, Y., Pizzol, D., Cosco, T., Thompson, T., Carnaghi, M., Bertoldo, A., Solmi, M., Stubbs, B., & Veronese, N. (2017). High prevalence of erectile dysfunction in diabetes: a systematic review and meta-analysis of 145 studies. Diabetic Medicine, 34(9), 1185–1192. https://doi.org/10.1111/dme.13403
  16. Lee, H. S., Lee, Y. J., Chung, Y. H., Lee, M. Y., Kim, S. T., Ko, S. K., Momoi, M., Kondoh, Y., Sasaki, F., & Jeong, J. H. (2016). In vitro and in vivo evaluation of tissue-cultured mountain ginseng on penile erection. Journal of Ginseng Research, 40(4), 334–343. https://doi.org/10.1016/j.jgr.2015.10.003
  17. Leslie, S. W., & Sooriyamoorthy, T. (2024, January 9). Erectile dysfunction. PubMed; StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK562253/
  18. Mutha, A. S., Mutha, S. A., Tejuja, A. H., Beldar, A. S., Mulay, A. M., & Langade, D. (2025). Efficacy and safety of eight-week therapy with ashwagandha root extract in improvement of sexual health in healthy men: Findings of a prospective, randomized, double-blind, placebo-controlled study. Journal of Ayurveda and Integrative Medicine, 16(4), 101155. https://doi.org/10.1016/j.jaim.2025.101155
  19. Pellegrino, F., Sjoberg, D. D., Tin, A. L., Benfante, N. E., Briganti, A., Montorsi, F., Eastham, J. A., Mulhall, J. P., & Vickers, A. J. (2022). Relationship between age, comorbidity, and the prevalence of erectile dysfunction. European Urology Focus, 9(1), 162–167. https://doi.org/10.1016/j.euf.2022.08.006
  20. Reiter, W. J., Pycha, A., Schatzl, G., Pokorny, A., Gruber, D. M., Huber, J. C., & Marberger, M. (1999). Dehydroepiandrosterone in the treatment of erectile dysfunction: A prospective, double-blind, randomized, placebo-controlled study. Urology, 53(3), 590–594; discussion 594-595. https://doi.org/10.1016/s0090-4295(98)00571-8
  21. Reiter, W. J., Schatzl, G., Märk, I., Zeiner, A., Pycha, A., & Marberger, M. (2001). Dehydroepiandrosterone in the treatment of erectile dysfunction in patients with different organic etiologies. Urological Research, 29(4), 278–281. https://doi.org/10.1007/s002400100189
  22. Rhim, H. C., Kim, M. S., Park, Y.-J., Choi, W. S., Park, H. K., Kim, H. G., Kim, A., & Paick, S. H. (2019). The potential role of arginine supplements on erectile dysfunction: A systemic review and meta-analysis. The Journal of Sexual Medicine, 16(2), 223–234. https://doi.org/10.1016/j.jsxm.2018.12.002
  23. Rosen, R. C., Riley, A., Wagner, G., Osterloh, I. H., Kirkpatrick, J., & Mishra, A. (1997). The international index of erectile function (IIEF): A multidimensional scale for assessment of erectile dysfunction. Urology, 49(6), 822–830. https://doi.org/10.1016/s0090-4295(97)00238-0
  24. Shin, D., Jeon, S. H., Piao, J., Park, H. J., Tian, W. J., Moon, D. G., Ahn, S. T., Jeon, K.-H., Zhu, G. Q., Park, I., Park, H.-J., Bae, W. J., Cho, H. J., Hong, S.-H., & Kim, S. W. (2023). Efficacy and safety of maca (Lepidium meyenii) in patients with symptoms of late-onset hypogonadism: A randomized, double-blind, placebo-controlled clinical trial. The World Journal of Men’s Health, 41(3), 692–700. https://doi.org/10.5534/wjmh.220112
  25. Tsujimura, A., Hiramatsu, I., Aoki, Y., Shimoyama, H., Mizuno, T., Nozaki, T., Shirai, M., Kobayashi, K., Kumamoto, Y., & Horie, S. (2017). Atherosclerosis is associated with erectile function and lower urinary tract symptoms, especially nocturia, in middle-aged men. Prostate International, 5(2), 65–69. https://doi.org/10.1016/j.prnil.2017.01.006
  26. Ulloa Del Carpio, N., Alvarado-Corella, D., Quiñones-Laveriano, D. M., Araya-Sibaja, A., Vega-Baudrit, J., Monagas-Juan, M., Navarro-Hoyos, M., & Villar-López, M. (2024). Exploring the chemical and pharmacological variability of Lepidium meyenii: a comprehensive review of the effects of maca. Frontiers in Pharmacology, 15, 1360422. https://doi.org/10.3389/fphar.2024.1360422
  27. Vilar Neto, J. O., de Moraes, W. M. A. M., Pinto, D. V., da Silva, C. A., Caminha, J. S. R., Nunes Filho, J. C. C., Reis, C. E. G., Prestes, J., Santos, H. O., & De Francesco Daher, E. (2025). Effects of tribulus (Tribulus terrestris L.) supplementation on erectile dysfunction and testosterone levels in men—A systematic review of clinical trials. Nutrients, 17(7), 1275–1275. https://doi.org/10.3390/nu17071275
  28. Wang, Y., & Jiang, R. (2024). Androgens and erectile dysfunction: From androgen deficiency to treatment. Sexual Medicine Reviews, 12(3), 458–468. https://doi.org/10.1093/sxmrev/qeae030
  29. Zenico, T., Cicero, A. F. G., Valmorri, L., Mercuriali, M., & Bercovich, E. (2009). Subjective effects of Lepidium meyenii (maca) extract on well-being and sexual performances in patients with mild erectile dysfunction: a randomised, double-blind clinical trial. Andrologia, 41(2), 95–99. https://doi.org/10.1111/j.1439-0272.2008.00892.x