Oral Herbal Combination Formulation and Hair Growth in Women

Hair Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05019066
• Other study ID #: 1396273
• Status: Withdrawn
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2022
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Hair Loss
• Hair Thinning
• Hypotrichosis

Intervention

Dietary Supplement:
• Herbal Supplementation
A proprietary blend of: Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Global Hair Growth and Global Hair Quality Assessment by investigator Hair Loss Subjective Questionnaire Symptom questionnaire		24-weeks