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

NCT06146166 | Active Not Recruiting

• 1 other identifier: i23-10-VIDYA_HAIR_SUPP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hair Thinning

Outcome Measures

Primary Outcomes (1)

• Hair density

  Change in hair density as measured by Trichogram based photographic analysis

  24 weeks

Secondary Outcomes (8)

• Hair density

  4 weeks

• Hair diameter

  24 weeks

• Hair diameter

  4 weeks

• Shannon diversity of hair microbiome

  24 weeks

• Hair health measured by global photographs as subjective factors graded by the investigator

  4 weeks

Study Arms (2)

Oral herbal supplement

EXPERIMENTAL

Oral supplement containing an herbal blend

Dietary Supplement: Oral herbal supplement

Oral Placebo Supplement

PLACEBO COMPARATOR

Oral placebo supplement

Dietary Supplement: Oral placebo supplement

Interventions

Oral herbal supplement DIETARY_SUPPLEMENT

Oral supplement containing an oral blend taken once daily

Oral herbal supplement

Oral placebo supplement DIETARY_SUPPLEMENT

Oral placebo supplement taken once daily

Oral Placebo Supplement

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integrative Skin Science and Research: lead
• Vidya Herbs (Sponsor): collaborator

Study Sites (1)

Integrative Skin and Research

Sacramento, California, 95815, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: February 22, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)