NCT05339958

Nutraceutical Supplement With Standardized Botanicals in Males With Thinning Hair

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Nutraceutical Supplement With Standardized Botanicals in Males With Self-Perceived Thinning Hair

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Nutraceutical Wellness Inc. · Industry
• Sex: Male
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to assess the effectiveness and safety of a novel dietary supplement containing botanical ingredients for hair thinning in men over the course of six months of continuous daily usage.

Detailed description

Hair thinning is a common condition affecting both men and women that is more recently understood to be the result of multiple causes. Although it is generally a benign condition, hair thinning can have a significant, detrimental impact on self-esteem, psychosocial functioning and the overall quality of life of affected individuals. It can also represent a substantial financial burden on individuals seeking treatment. The objective of this randomized, double-blind, placebo-controlled study is to assess the effectiveness and safety of a novel dietary supplement containing botanical ingredients for hair thinning over the course of six months of continuous daily usage. The study supplement is scientifically formulated to specifically target the multiple underlying causes of hair thinning. In addition to the necessary vitamins, minerals, and proteins to support the nutritional needs of hair, it also contains clinically tested, standardized pharmaceutical-grade botanicals (substances obtained from plants) that target hormones, stress and inflammatory markers.

Conditions

• Hair Thinning

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutrafol® Men Hair Growth Nutraceutical	Nutrafol® Men contains patented Synergen Complex® is a blend of proprietary formulation of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant and DHT-inhibiting properties - combined to synergistically combat the multiple underlying factors that compromise hair growth and health. These ingredients include Sensoril Ashwagandha, BCM-95 BioCurcumin, USPlus Saw Palmetto, EVNolMax 20% Tocotrienol/Tocopherol complex, Bioperine (piperine), Cynatine HNS (solubilized keratin), and Capsimax (capsaicin).
OTHER	Placebo Supplement	The placebo capsules contain no active ingredients.

Timeline

• Start date: 2021-07-19
• Primary completion: 2023-04-05
• Completion: 2023-04-05
• First posted: 2022-04-21
• Last updated: 2023-08-01

Locations

2 sites across 1 country: United States