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Efficacy and safety of a standardized botanical nutraceutical supplement in perimenopausal and menopausal women with thinning hair

Randomized, double-blind, placebo-controlled trial evaluating the ability and safety of a nutraceutical supplement with standardized herbal ingredients to promote hair growth in perimenopausal, menopausal, and postmenopausal women with self-perceived thinning hair

NUTRAFOL® Women's Balance is a new nutraceutical supplement scientifically formulated specifically to address many of the leading causes of hair loss and thinning in women. NUTRAFOL® Women's Balance Capsules are formulated with primary and secondary ingredients designed to restore hair health from within. In addition to essential vitamins, minerals and proteins to meet the nutritional needs of hair, it also contains nutraceutical grade botanical bioactives that are standardized and clinically tested. The formula utilizes the multifaceted properties of power plants that have a full spectrum of phytochemicals with innate abilities to work in synergy with each other to fulfill their specific therapeutic role. Using the latest biotechnologies, these ingredients are bio-optimized and standardized, extracted using proprietary methods that preserve their bioactive integrity and become more bioavailable and bioabsorbable with special proprietary technologies.

Taking a NUTRAFOL® Women's Balance supplement for six (6) months will strengthen and promote hair growth in perimenopausal, menopausal, and postmenopausal women with a self-perceived thinning hair compared to baseline and those taking a placebo pill. , with further improvement over the next six (6) months of the open extended period.

Study Overview

DETAILED DESCRIPTION

NUTRAFOL® Women's Balance is a new nutraceutical supplement scientifically formulated specifically to address many of the leading causes of hair loss and thinning in women. NUTRAFOL® Women's Balance Capsules are formulated with primary and secondary ingredients designed to restore hair health from within. In addition to essential vitamins, minerals and proteins to meet the nutritional needs of hair, it also contains nutraceutical grade botanical bioactives that are standardized and clinically tested. The formula utilizes the multifaceted properties of power plants that have a full spectrum of phytochemicals with innate abilities to work in synergy with each other to fulfill their specific therapeutic role. Using the latest biotechnologies, these ingredients are bio-optimized and standardized, extracted using proprietary methods that preserve their bioactive integrity and become more bioavailable and bioabsorbable with special proprietary technologies.

Synergen Complex Plus® by NUTRAFOL is a formulation based on the patented Synergen Complex®, a combination of botanicals with powerful anti-inflammatory, anti-stress, adaptogenic, antioxidant, DHT inhibiting and hormone balancing properties. major factors that compromise hair growth and health. Some key ingredients include Sensoril Ashwagandha, BCM-95 BioCurcumin, Saw Palmetto, EVNolMax 20% Tocotrienol/Tocopherol Complex, Gelatinized Maca, Astaxanthin, Bioperine (Piperine), and Capsimax (Capsaicin), all of which are biooptimized and clinically tested.

Taking a NUTRAFOL® Women's Balance supplement for six (6) months will strengthen and promote hair growth in perimenopausal, menopausal, and postmenopausal women with a self-perceived thinning hair compared to baseline and those taking a placebo pill. , with further improvement over the next six (6) months of the open extended period. Primary endpoints will be favorable analysis using the Canon Power Shot G16 with 3GEN Dermlite FOTO Pro for macrophotographic analysis of terminal, vellus and general hair at three (3) and six (6) months. Secondary endpoints will include favorable analysis using the Canon Power Shot G16 with 3GEN Dermlite FOTO Pro for macrophotographic analysis of terminal, vellus and general hair at nine (9) and twelve (12) months visits. Other secondary endpoints would be a beneficial improvement in terminal hair diameter measured with a Dino-Lite digital microscope, a beneficial improvement in hair growth and quality as measured by a global hair assessment by a blind physician, a reduction in hair loss with a hair washing procedure, and a statistically significant positive feedback. on questionnaires on the Women's Hair Loss Quality of Life Scale, Self-Report, Treatment Satisfaction and Ease of Use, Hair Satisfaction, and Menopause at three (3), six (6), nine (9), and twelve (12) month visits. The study end point would be a favorable improvement in hair tuft measurement with the Hair Check Device for Hair Mass Index (HMI) at three (3), six (6), nine (9), and twelve (12) months of visit. See Table of Test Procedures.

A minimum of seventy (70) women will be included in this clinical study; Forty (40) subjects will receive the active substance and thirty (30) subjects will receive a placebo.

Contacts and location

This section provides contact information for individuals conducting the study and information about where the study is conducted.