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| Name | Class |
|---|---|
| Vidya Herbs (Sponsor) | UNKNOWN |
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The purpose of this study is to assess how an oral herbal supplement influences hair density, shine, growth, and microbiome.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral herbal supplement | Experimental | Oral supplement containing an herbal blend |
|
| Oral Placebo Supplement | Placebo Comparator | Oral placebo supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral herbal supplement | Dietary Supplement | Oral supplement containing an oral blend taken once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hair density | Change in hair density as measured by Trichogram based photographic analysis | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hair density | Change in hair density as measured by Trichogram based photographic analysis | 4 weeks |
| Hair diameter | Change in hair diameter and hair diameter |
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Inclusion Criteria:
- Men and women between the ages of 25 years old and 65 years old with self-perceived hair thinning.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin and Research | Sacramento | California | 95815 | United States |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Oral placebo supplement | Dietary Supplement | Oral placebo supplement taken once daily |
|
| 24 weeks |
| Hair diameter | Change in hair diameter and hair diameter | 4 weeks |
| Shannon diversity of hair microbiome | Shift in Shannon diversity measure of the hair microbiome | 24 weeks |
| Hair health measured by global photographs as subjective factors graded by the investigator | Change in hair growth, density, and shine measured by global photographs as subjective factors graded by the investigator | 4 weeks |
| Hair health measured by global photographs as subjective factors graded by the investigator | Change in hair growth, density, and shine measured by global photographs as subjective factors graded by the investigator | 24 weeks |
| Self-perception of hair | 10-question survey based self grading of hair growth, density, and shine measured with subjective questionnaire. Answers range from Strongly Agree, Agree, Neutral, Disagree, or Strongly Disagree. | 4 weeks |
| Self-perception of hair | 10-question survey based self grading of hair growth, density, and shine measured with subjective questionnaire. Answers range from Strongly Agree, Agree, Neutral, Disagree, or Strongly Disagree. | 24 weeks |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |