Oral Herbal Combination Formulation and Hair Growth in Women

• ClinicalTrials.gov Identifier: NCT05019066
• Recruitment Status: Withdrawn
• First Posted: August 24, 2021
• Last Update Posted: October 27, 2021
• Sponsor: University of California, Davis
• Information provided by (Responsible Party): University of California, Davis

Tracking Information

• First Submitted Date: August 4, 2021
• First Posted Date: August 24, 2021
• Last Update Posted Date: October 27, 2021
• Estimated Study Start Date: September 30, 2021
• Estimated Primary Completion Date: February 22, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 19, 2021)

Scalp photography Microscopic evaluation of hair Trichometry using the HairCheck© device [ Time Frame: 24 weeks ]

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).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: August 19, 2021): Global Hair Growth and Global Hair Quality Assessment by investigator Hair Loss Subjective Questionnaire Symptom questionnaire [ Time Frame: 24-weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oral Herbal Combination Formulation and Hair Growth in Women
• Official Title: The Effect of an Oral Herbal Combination Formulation on Hair Growth in Women With Self-perceived Hair Loss
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Other

Condition

• Hair Loss
• Hair Thinning

Intervention

Dietary Supplement: Herbal Supplementation

A proprietary blend of: Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa.

Study Arms

• 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
  Intervention: Dietary Supplement: Herbal Supplementation
• 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
  Intervention: Dietary Supplement: Herbal Supplementation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: October 19, 2021): 0
• Original Estimated Enrollment (submitted: August 19, 2021): 36
• Estimated Study Completion Date: June 1, 2022
• Estimated Primary Completion Date: February 22, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Women with self-perceived hair loss as confirmed by the investigator.

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05019066
• Other Study ID Numbers: 1396273
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of California, Davis
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, Davis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of California, Davis
• Verification Date: October 2021