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When compared to the placebo, hair growth and quality significantly improved by day 180.
Investigators tested the efficacy and safety of a nutraceutical oral supplement in male patients with thinning hair.1 The botanical therapy significantly improved hair growth and quality with no adverse effects or changes in sexual function. The nutraceutical was evaluated on its own, not in combination with other therapies.
The randomized, double-blind, multi-center, placebo-controlled trial (NCT05339958) took place between July 2021 and October 2022. It included men between the ages of 21 and 61, with a mean age of 38.4 in the active group and 42.7 in the placebo group. A total of 85 participants were separated into 2 groups, nutraceutical (n=52) and placebo (n=33), at a 2:1 ratio.
The trial focused on men who experience patterned hair loss due to hormones, stress, nutrition, aging, and metabolism. They were classified as Level II, IIA, III, IIIv, and IV using the Norwood–Hamilton scale. Hair thinning was confirmed by a dermatologist and did not include those with a clinical diagnosis of alopecia.
The participants took 4 capsules once a day with food. The supplement ingredients included saw palmetto, ashwagandha, vitamin E, curcumin, and a combination of other botanicals, vitamins, and minerals. Visits took place at baseline, day 90, and day 180 with compliance calls on day 45 and day 135. During these visits, clinicians conducted a physical examination with photographs, hair shed pull tests, and questionnaires.
As endpoints, researchers assessed positive changes in the blinded Global Investigator Ratings for hair growth and quality, the Men's Hair Growth Questionnaire (MHGQ), the Perceived Stress Scale (PSS), and the Arizona Sexual Experience Scale (ASEX). Hair brittleness, dryness, texture, shine, scalp coverage, and overall appearance helped to determine quality.
By day 180, hair growth and quality significantly improved in the nutraceutical compared to placebo (p < 0.01). Compared to baseline, 74% of patients rated their growth and quality as improved versus the placebo at 54% (p = 0.026). The placebo cohort had more ratings of “no change” or “worsened” compared to the supplement group (p > 0.05.) Hair appearance and coverage also improved, according to the MHGQ results.
More patients in the active group reported overall treatment satisfaction, 83% versus 66% respectively. Most participants in both groups expressed the ease of adding the capsules to their routine, saying that it was easier to take the 4 supplements once daily than to apply a topical product once or twice a day.
Both groups remained “moderately stressed” based on the PSS, but the nutraceutical cohort saw slightly improved scores after treatment. There were also no changes in sexual dysfunction, according to ASEX.
Adverse events were noted in 6 patients, 3 from each group. These were all related to gastrointestinal upset such as bloating, irritable stomach, diarrhea, and intermittent nausea. No serious adverse effects were reported, making the therapy well-tolerated.
Although this blind study design is a promising start in evaluating the supplement, upcoming trials should include phototrichograms for metrics to further quantify additional hair count and growth.
Hair loss and thinning affects two-thirds of men over the age of 35.2 Current treatments include OTC topical minoxidil, prescription medications like finasteride, low-level light therapy, platelet-rich plasma injection, and transplants.
“While addressing male hair loss and thinning clinically is usually done through a combination of therapies, the study here provides support for the benefits in hair growth and quality of the nutraceutical alone,” the authors wrote.
References
1. Bhatia N, Ablon G, Farris PK, Hazan A, Raymond I. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Nutraceutical Supplement With Standardized Botanicals in Males With Thinning Hair. J Cosmet Dermatol. 2025;24(1):e16778. doi:10.1111/jocd.16778
2. American Hair Loss Association, “Men's Hair Loss,” 2024, accessed January 17, 2025, https://www.americanhairloss.org/mens-hair-loss/.