NUTRAFOL's Synergen Complex Plus® is a formulation based on a patent-pending Synergen Complex®, a combination of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant, DHT-inhibiting and hormone-rebalancing properties - combined to synergistically combat the multiple underlying 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 bio-optimized and clinically tested.
Subjects to take four (4) Nutrafol Supplement capsules by mouth daily for 180 days with a substantial meal.

The placebo capsules contain no active ingredients. Subjects to take four (4) Placebo capsules by mouth daily for 180 days with a substantial meal.

During the 6 month open label extension all 70 subjects will receive NUTRAFOL's Synergen Complex Plus® which is a formulation based on a patent-pending Synergen Complex®, a combination of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant, DHT-inhibiting and hormone-rebalancing properties - combined to synergistically combat the multiple underlying 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 bio-optimized and clinically tested.
Subjects to take four (4) Nutrafol Supplement capsules by mouth daily for the six month extension with a substantial meal.

Hair Thinning

1. Females, age 40-65, who are perimenopausal, menopausal or post-menopausal. Perimenopausal is defined as increased variability in menstrual cycle length and defined as persistent difference of 7 days or more in length of consecutive cycles. Later stages include amenorrhea for 60 days or longer and/or vasomotor symptoms. These should have been present for at least 6 months prior to study. Menopause is defined as absence of menstrual bleeding for at least 12 months or 12 months status post complete Hysterectomy with Oophorectomy.

NUTRAFOL's Synergen Complex Plus® is a formulation based on a patent-pending Synergen Complex®, a combination of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant, DHT-inhibiting and hormone-rebalancing properties - combined to synergistically combat the multiple underlying 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 bio-optimized and clinically tested. The Nutafol supplement capsules are compared to the placebo capsules which contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial meal.

Nutrafol Supplement Capsules

The placebo capsules contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial amount of food.

Placebo Capsules

Ablon Skin Institute & Research Center

Efficacy and Safety of a Nutraceutical Supplement With Standardized Botanicals in Peri-menopausal and Menopausal Women With Thinning Hair

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Ability And Safety Of A Nutraceutical Supplement With Standardized Botanicals To Promote Hair Growth In Perimenopausal, Menopausal And Post-Menopausal Women With Self-Perceived Thinning Hair

Terminal hair is defined as coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of 40 micrometers.

Vellus hair is defined as fine, short hairs found on the scalp with maximum cross-sectional diameter of 40 micrometers.

Total Hairs equals the sum of Terminal and Vellus Hairs in the Target Area

Terminal hair is defined as coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of 40 micrometers. Vellus hair is defined as fine, short hairs found on the scalp with maximum cross-sectional diameter of 40 micrometers. Total Hairs equals the sum of Terminal and Vellus Hairs in the Target Area

Ten (10) terminal hairs just outside the border of the 2 cm x 2 cm area used for the Hair Check Hair Mass Index (HMI) will be randomly chosen (not all from one direct area) and cut at the surface of the scalp thus not creating any bald patches. The Dino-Lite Microscope will then be used to measure the diameter of each of the ten (10) hairs at 1mm from the cut end of the hair. All calibrations and measurement will be done at the setting of 230X. The ten (10) hair measurements will then be recorded on the Hair Diameter Log Form. All ten (10) diameters will be added together and then divided by 10 to attain an average hair diameter for the area and the average diameter will be recorded in the CRF. See Appendix IV.

Subjects will be instructed to wash their hair at home 24 hours in advance of study visits 1, 2, 3, 4 and 5. Subjects will then have their hair washed (shampooed) with a gentle shampoo in the office over a sink containing cheesecloth. The cheesecloth will be positioned to collect shedding hair. The number of hairs collected in the cheesecloth will be counted and recorded. Subjects will be allowed to dry and style their hair. Subjects will have their hair washed and shedding hairs counted on Visits 1, 2, 3, 4 and 5. See Appendix V.

The treating investigator will complete this live assessment by circling the number on the scale that corresponds to the description that best fits the current global growth improvement and current hair quality Investigator Assessment Scale
3 Greatly increased
2 Moderately increased
1 Slightly increased 0 No change
1 Slightly worsened
2 Moderately worsened
3 Greatly worsened

Please complete the following questions by circling the number in the column which best describes your opinion for each characteristic.
Very Much (4) A Lot (3) A Little (2) Not At All (1) Not Relevant (0)
I am embarrassed by my thinning hair.
Because of my thinning hair, I avoid social gatherings.
I don't like meeting new people as I feel they are judging me because of my thinning hair.
I avoid going out during the day because of my thinning hair.
My condition impacts my emotional state at work.
I feel my thinning hair has impacted my ability to succeed in interviews.
My condition has prevented my participation in a sports activity.
My condition impacts my self esteem.
My condition makes me feel self conscious about my thinning hair.
Because of my thinning hair, I fear being the center of attention.
I feel my thinning hair is affecting my personal relationships.
Because of my thinning

Please complete the following questions by circling the number in the column which best describes your opinion for each characteristic; from +3 (greatly increased/improved) to -3 (greatly decreased/worsened)
Greatly Increased/Improved +3
Moderately Increased/Improved +2
Slightly Increased/Improved +1
No Change 0
Slightly Decreased/Worsened -1
Moderately Decreased/Worsened -2
Greatly Decreased/Worsened -3
Overall hair growth Overall hair volume Scalp coverage Thickness of hair body Hair amount Hair quality Hair color Hair shine Hair strength Softness of hair body Amount of new hair Hair growth rate Hair length Ease of styling Overall hair appearance Sleep Quality Overall Well-Being Nail strength +3 Nail Growth rate Growth of Eyebrow hair Growth of eyelashes Skin smoothness Overall skin health Energy levels Libido (Sex drive)
Please complete the following questions by circling the number in

Subject Treatment Satisfaction:
Please circle the number on the scale that corresponds to the description that you believe best fits your current satisfaction with the study treatment.
Subject Satisfaction Scale Description
3 Extremely Satisfied
2 Moderately Satisfied
1 Slightly Satisfied 0 No change
1 Slightly Unsatisfied
2 Moderately Unsatisfied
3 Greatly Unsatisfied

Questionnaire
Subject Hair Satisfaction Questionnaire:
Please check the box next to the description of your current state of hair health, which most accurately describes your current feelings of how satisfied you are with the amount and quality of hair on your scalp, including scalp coverage, volume and overall appearance.
Subject Satisfaction Scale Description
3 Extremely Satisfied
2 Moderately Satisfied
1 Slightly Satisfied 0 No change
1 Slightly Unsatisfied
2 Moderately Unsatisfied
3 Greatly Unsatisfied

Questionnaire This is a standardized scale and cannot be copied into this document.

Ablon Skin Institute Research Center

Nutraceutical Wellness Inc.

This is a six (6) month double-blind, randomized, placebo-controlled study with a six (6) month open-label extension to assess the safety and efficacy of Nutrafol® Women's Balance oral supplement in improving hair growth in perimenopausal, menopausal and post-menopausal female subjects with self-perceived thinning hair. After an initial screening period to determine eligibility, subjects will be randomly assigned to one of the following treatment arms: Nutrafol® vs. Placebo for the initial 6 months of the trial. All subjects (Nutrafol® and placebo groups) will receive the active treatment (Nutrafol®) throughout the latter 6-month open-label extension/follow-up period.

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Efficacy and Safety of a Nutraceutical Supplement With Standardized Botanicals in Peri-menopausal and Menopausal Women With Thinning Hair

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