The Effects of an Oral Hair Supplement on Hair Density, Growth, and Microbiome

NCT ID: NCT06146166

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-22
• Study Completion Date: 2025-01-10

Brief Summary

The purpose of this study is to assess how an oral herbal supplement influences hair density, shine, growth, and microbiome.

Detailed Description

Hair thinning and hair loss are highly prevalent conditions affecting both men and women. Various factors can contribute to hair thinning and loss, including nutrition, medications, family history, and more. Overall, hair thinning and loss have a significant impact on quality of life and patients with these concerns have limited options. For example, minoxidil, finasteride, hair transplantations, and platelet rich plasma are effective options but each are paired with their own limitations. Thus, those with hair thinning or loss are increasingly turning to natural therapies shown to improve hair density and self-perceived hair thinning.

Nutrition is closely related to hair health, as evidenced by hair thinning and loss that occur with malnutrition or restrictive diets. Additionally, the hair follicle microbiome has been shown to modulate inflammation that exacerbates inflammatory scalp diseases, and ultimately hair thinning and hair loss.

Thus, an oral supplement that addresses nutrient deficiencies and targets the hair follicle microbiome could support hair health. In this study, we examine the effects of an herbal oral supplement on hair density, shine, and growth.

Conditions

Hair Thinning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oral herbal supplement

Oral supplement containing an herbal blend

Group Type: EXPERIMENTAL

Oral herbal supplement

Intervention Type: DIETARY_SUPPLEMENT

Oral supplement containing an oral blend taken once daily

Oral Placebo Supplement

Oral placebo supplement

Group Type: PLACEBO_COMPARATOR

Oral placebo supplement

Intervention Type: DIETARY_SUPPLEMENT

Oral placebo supplement taken once daily

Interventions

Oral herbal supplement

Oral supplement containing an oral blend taken once daily

Intervention Type: DIETARY_SUPPLEMENT

Oral placebo supplement

Oral placebo supplement taken once daily

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Men and women between the ages of 25 years old and 65 years old with self-perceived hair thinning.

Exclusion Criteria

• Individuals who are pregnant or breastfeeding.
• Prisoners.
• Adults unable to consent.
• Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
• Subjects with scarring forms of alopecia.
• Any history of procedures affecting hair growth, such as transplantation
• Any known allergy to any of the ingredients in the study product.
• Any laser treatments for hair growth in the past 3 months
• Use of any over-the-counter or pharmaceutical or dietary products known to affect hair growth
• Subjects unwilling to not alter hair color or style for the duration of the study.
• Subjects taking any hair growth oral supplementation within the past 3 months.
• Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
• Those who have been on an oral antibiotic within 1 month prior enrolling
• Those who are unwilling to discontinue oral probiotics-based supplementation or supplement ingredients found in the study's oral, product 1 month prior to enrollment

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vidya Herbs (Sponsor)

UNKNOWN

Sponsor Role: collaborator

Integrative Skin Science and Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Integrative Skin and Research

Sacramento, California, United States

Countries

United States

Other Identifiers

i23-10-VIDYA_HAIR_SUPP

Identifier Type: -

Identifier Source: org_study_id