Oral Herbal Combination Formulation and Hair Growth in Women
NCT ID: NCT05019066
Last Updated: 2021-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-09-30
2022-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Herbal Combination Group
* 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
Herbal Supplementation
A proprietary blend of: Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa.
Placebo Group
* 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
Herbal Supplementation
A proprietary blend of: Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa.
Interventions
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Herbal Supplementation
A proprietary blend of: Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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University of California, Davis
OTHER
Responsible Party
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Other Identifiers
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1396273
Identifier Type: -
Identifier Source: org_study_id