Oral Herbal Combination Formulation and Hair Growth in Women

Study Overview
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Brief Summary
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The purpose of this research is to test the effects of an herbal combination formulation on hair growth in women with self-perceived hair loss.The information from this study may help to better understand how certain herbal supplements can affect hair growth. This may lead to better understanding of the hair, hair loss and help develop naturally-based treatment regimens in the future.

Official Title
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The Effect of an Oral Herbal Combination Formulation on Hair Growth in Women With Self-perceived Hair Loss

Conditions
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Hair Loss, Hair Thinning

Intervention / Treatment
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* Dietary Supplement: Herbal Supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and above Subject must be able to read and comprehend study procedures and consent forms. Women with self-perceived hair loss as confirmed by the investigator. Willing to maintain the same hairstyle, hair color, hair length and hair regimen throughout the study period. Subjects with color-treated hair will have the color treatment performed at the same time interval prior to each visit (if the color treatment was done 1 week prior to Visit 1, it should be repeated 1 week prior to Visit 2). Willing to keep diet and exercise routine consistent throughout study Exclusion Criteria: Subjects should be generally healthy and have no smoking history in the past one year. Subjects must have no history of diabetes, metabolic syndrome, HIV, immune deficiency, autoimmune disease known cardiovascular disease, malignancy, kidney disease, or chronic steroid use. Women who are pregnant, planning to become pregnant or breastfeeding Those who are unable to discontinue medicated shampoos or topical scalp medications for two weeks prior to and during the study. Those who are unable to discontinue supplements containing Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa for one month prior to starting the study Those who have a known allergy to Eclipta alba, Emblica officinalis, Centella asiatica or Hibiscus sabdariffa Use of hair regrowth products in the previous 6 months Using or planned use of non-breathable wigs Those with a history of hair transplantation procedure Presence of other dermatological disorders causing alopecia Chemotherapy, radiation therapy or laser therapy (of scalp) in the last 6 months Light therapy in the past 3 months Participants using hormonal birth control unless on a stable / unchanged regimen for at least 3 months. Systemic treatment during the last 3 months before study inclusion that could interfere with the study medications (ie, minoxidil, corticosteroids, Aminexil, topical estrogens, ketoconazole, beta blocker, cimetidine, diazoxide, isotretinoin or vitamin A intake >10,000 IU/d) Use of ocular prostaglandins for less than 4 months before first study visit Those that are prisoners or cognitively impaired

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Herbal Combination Group<br>Tablets of the herbal formulation will be supplied from Banyan Botanicals (https://www.banyanbotanicals.com/healthy-hair-tablets-10) Each 500 mg tablet contains a proprietary blend of: Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa Dose: subjects in this group will take 2 herbal formulation tablets twice per day for a total of 4 tablets per day | Dietary Supplement: Herbal Supplementation<br>* A proprietary blend of: Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa.<br>|
| Placebo Comparator: Placebo Group<br>Supplement appearing similar to the herbal combination formulation. Each placebo tablet will contain microcrystalline cellulose, dicalcium phosphate, PVPK30, sodium starch glycolate, magnesium stearate, OpaDry orange coating. Dose: subjects in this group will take 2 placebo tablets twice per day for a total of 4 tablets per day | Dietary Supplement: Herbal Supplementation<br>* A proprietary blend of: Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scalp photography Microscopic evaluation of hair Trichometry using the HairCheck© device | The HairCheck Trichometer will be used to measure hair caliber and hair density together and expresses them as a single number called the Hair Mass Index (HMI) or Hair Number. The hair mass index (HMI) is ratio of the cross-sectional area of an isolated bundle of hair and the pre-measured area of skin from which it was taken using the trichometer device. The Folliscope (LeadM Corp, Seoul, South Korea)a phototrichogram device.5 will be used to measure density and hair diameter (per/cm2). | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Hair Growth and Global Hair Quality Assessment by investigator Hair Loss Subjective Questionnaire Symptom questionnaire |  | 24-weeks |