Oral Herbal Combination Formulation and Hair Growth in Women

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hair Loss; Hair Thinning
• Intervention / Treatment: Dietary supplement: Herbal Supplementation

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Dietary supplement: Herbal Supplementation; A proprietary blend of: Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa.
PLACEBO_COMPARATOR: 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	Dietary supplement: Herbal Supplementation; A proprietary blend of: Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 30, 2021
• Primary Completion (ANTICIPATED): February 22, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (ACTUAL): August 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hair Diseases; Alopecia; Alopecia Areata; Hypotrichosis
• Other Study ID Numbers: 1396273

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No