Dietary Supplement for Hair Loss

Recruiting at 2 trial locations

Overseen By Emily Hu

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Nutraceutical Wellness Inc.

Must not be taking: Steroids, Immunosuppressants, Antidepressants, others

Disqualifiers: Hair loss disorders, Skin infections, others

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

174 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to avoid using any prescription or over-the-counter products that claim to impact hair loss or growth during the study. If you are on hormone replacement therapy, you must maintain a stable dose. Other medications may need to be reviewed for eligibility.

What data supports the effectiveness of the treatment Dietary Supplement for hair loss?

Research shows that certain dietary supplements can help with hair growth. For example, a study on a nutraceutical supplement found it significantly increased hair growth and improved hair quality in women with thinning hair. Another study on a supplement called Nourkrin showed positive effects on hair growth without side effects. ^{1 2 3 4 5}

Is the dietary supplement for hair loss safe for humans?

Some studies have shown that certain natural products used in hair loss treatments, like epigallocatechin gallate and saw palmetto extract, are generally safe and have beneficial effects on hair growth. However, there is a lack of regulatory oversight and comprehensive safety data for many dietary supplements marketed for hair health. ^{6 7 8 9 10}

How is the dietary supplement treatment for hair loss different from other treatments?

This dietary supplement is unique because it uses a blend of highly purified and standardized botanical extracts that target multiple causes of hair loss, such as inflammation and stress, unlike traditional treatments like minoxidil and finasteride which focus on single mechanisms. It offers a natural alternative that addresses both the triggers and the downstream effects of hair loss. ^{1 4 10 11 12}

What is the purpose of this trial?

A study to assess the safety and efficacy of a dietary supplement when used over the course of 9 months by men with self-perceived hair thinning.

Eligibility Criteria

This trial is for aging males who notice their hair thinning. Participants should be experiencing hair loss conditions like Alopecia Areata but not have hairy birthmarks or other forms of Alopecia.

Inclusion Criteria

I consider myself to be in good health.

I am willing to undergo the Hair Pull Test.

I am willing to avoid hair extensions, tight braids, or weaves.

Exclusion Criteria

I am experiencing hair loss due to a specific cause.

Having a pregnant partner or a partner planning to become pregnant during the study

Having specific hairstyles or hair lengths

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the dietary supplement or placebo for 9 months

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dietary Supplement

Trial Overview The study tests a dietary supplement against a placebo over 9 months to see if it's safe and effective in treating men's hair thinning.

Participant Groups

Group I: Active Experimental Treatment 1 Intervention

Dietary Supplement

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Nutraceutical Wellness Inc.

Lead Sponsor

Trials

8

Recruited

1,000+

Findings from Research

In a randomized, placebo-controlled study involving 15 healthy women over 180 days, an oral supplement significantly increased the number of terminal hairs in participants, with counts rising from 271 to 609.6 hairs compared to no change in the placebo group.

Participants taking the supplement reported noticeable improvements in hair volume, scalp coverage, and hair thickness, with no adverse events, indicating both safety and efficacy of the treatment for temporary hair thinning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Double-blind, Placebo-controlled Study Evaluating the Efficacy of an Oral Supplement in Women with Self-perceived Thinning Hair. Glynis, A.[2021]

A 6-month study involving 40 adult women showed that the nutraceutical supplement Nutrafol® significantly increased hair growth and quality, with improvements observed at both 90 and 180 days compared to a placebo.

The supplement was found to be safe, with no reported adverse events, and it effectively addressed hair loss by targeting inflammation, stress, and oxidative damage through its unique blend of active botanicals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Six-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Women With Self-Perceived Thinning Hair. Ablon, G., Kogan, S.[2018]

Viviscal®, a nutraceutical supplement containing proteins, lipids, and glycosaminoglycans from marine sources, has been shown in clinical studies to effectively stimulate hair growth and reduce hair shedding.

The supplement is considered safe and is part of a multi-therapy approach to treat alopecia and thinning hair, which is particularly challenging to diagnose and manage in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of a Sustainable Marine Extract for the Treatment of Thinning Hair: A Summary of New Clinical Research and Results from a Panel Discussion on the Problem of Thinning Hair and Current Treatments. Hornfeldt, CS., Holland, M., Bucay, VW., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Double-blind, Placebo-controlled Study Evaluating the Efficacy of an Oral Supplement in Women with Self-perceived Thinning Hair. [2021]

2. India pubmed.ncbi.nlm.nih.gov

Comparing the Effects of Zinc Sulfate, Calcium Pantothenate, Their Combination and Minoxidil Solution Regimens on Controlling Hair Loss in Women: A Randomized Controlled Trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Nourkrin: objective and subjective effects and tolerability in persons with hair loss. [2017]

4. India pubmed.ncbi.nlm.nih.gov

Controversy: is there a role for adjuvants in the management of male pattern hair loss? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Six-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Women With Self-Perceived Thinning Hair. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Safety Concerns of Skin, Hair and Nail Supplements in Retail Stores. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Real-World, Open-Label Study of the Efficacy and Safety of a Novel Serum in Androgenetic Alopecia. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Topically used herbal products for the treatment of hair loss: preclinical and clinical studies. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Safety and Effectiveness of Nutritional Supplements for Treating Hair Loss: A Systematic Review. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A Novel Multi-Targeting Approach to Treating Hair Loss, Using Standardized Nutraceuticals. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of a Sustainable Marine Extract for the Treatment of Thinning Hair: A Summary of New Clinical Research and Results from a Panel Discussion on the Problem of Thinning Hair and Current Treatments. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

QR678 & QR678 Neo Hair Growth Formulations: A Cellular Toxicity & Animal Efficacy Study. [2022]