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

What this trial studies

NUTRAFOL® Women's Balance supplement is a novel nutraceutical supplement, scientifically formulated to specifically target the multiple underlying causes of hair loss and thinning in women. NUTRAFOL® Women's Balance capsules are comprised of primary and secondary ingredients, designed to restore hair health from the inside out. In addition to the necessary vitamins, minerals, proteins to support the nutritional needs of hair, it also contains nutraceutical-grade botanical bioactives that are standardized and clinically tested. The formulation leverages the multidimensional properties of power plants, which possess a full spectrum of phytochemicals with innate capacities to work in synergy with each other to fulfill their specific therapeutic roles.

Conditions in scope

• Hair Thinning

Interventions

• Nutrafol Supplement Capsules (Dietary Supplement) — 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…
• Placebo Capsules (Other) — The placebo capsules contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial amount of food.

Who can join

Women only · Ages 40 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• \. 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.
• \. Clinically-determined general good health as determined by responses to the initial study assessment.
• \. Females with self-perceived thinning hair as confirmed on initial study assessment by the Investigator (This will not include patients with medically diagnosed telogen effluvium).
• \. Females willing to maintain their normal hair shampooing frequency.
• \. Females willing to add the provided oral supplement to their current daily routine.
• \. Females willing to not substantially change their current diet, medications, or exercise routines for the duration of the study. If a subject receives physician guidance during the study to change diet, medications, or exercise routine, the subject will need to notify the clinic as soon as possible.
• \. Females willing to undergo a brief physical exam to include height, weight, blood pressure, pulse, general physical findings and a scalp exam. The physical exam will occur at Visits 1, 2, 3, 4 and 5.
• \. Females with Fitzpatrick I-IV photo skin types.

Exclusion criteria

• Females who are of childbearing potential defined as still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal.
• Females with any known allergy or sensitivity to any shampoo/conditioner.
• Females with known stressful incident within the last six months (ie. death in family).
• Females who are participating on any clinical research study at ASIRC or at another research center or doctors office.
• Females who have recently (within the last 6 months) started the use of hormone replacement therapy (HRT). Women currently using hormones for HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study (the initiation of HRT should not have been associated with the initiation of hair loss/thinning).
• Females currently using any Low Level Laser Therapy (LLLT) to treat thinning hair.
• Females who have regularly used Rogaine (Minoxidil) within the last 3 months.
• Females who have used prescription drugs known to affect the hair growth cycle within the last 6 months (e.g., cyproterone acetate, aldactone/spironolactone, Finasteride or any 5-alpha-reductase inhibitor).

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2019-06-19
• Primary completion: 2020-09-30
• Last update posted: 2025-04-06
• First posted: 2019-08-07

Sponsor & contact

Lead sponsor: Ablon Skin Institute Research Center (Other)

Collaborators: Nutraceutical Wellness Inc.

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Number of Terminal Hairs in the Target Area of the Scalp (180 days)
  Terminal hair is defined as coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of 40 micrometers.
• Number of Vellus Hairs in the Target Area of the Scalp (180 days)
  Vellus hair is defined as fine, short hairs found on the scalp with maximum cross-sectional diameter of 40 micrometers.
• Number of Total Hairs in the Target Area of the Scalp (180 days)
  Total Hairs equals the sum of Terminal and Vellus Hairs in the Target Area

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.