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Oral Herbal Combination Formulation and Hair Growth in Women

Primary Purpose

Hair Loss, Hair Thinning

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Herbal Supplementation
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hair Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Herbal Combination Group

    Placebo Group

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Global Hair Growth and Global Hair Quality Assessment by investigator Hair Loss Subjective Questionnaire Symptom questionnaire

    Full Information

    First Posted
    August 4, 2021
    Last Updated
    October 19, 2021
    Sponsor
    University of California, Davis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05019066
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI decided not to proceed with study.
    Study Start Date
    September 30, 2021 (Anticipated)
    Primary Completion Date
    February 22, 2022 (Anticipated)
    Study Completion Date
    June 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Davis

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hair Loss, Hair Thinning

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Herbal Combination Group
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Placebo Group
    Arm Type
    Placebo Comparator
    Arm Description
    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 Type
    Dietary Supplement
    Intervention Name(s)
    Herbal Supplementation
    Intervention Description
    A proprietary blend of: Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa.
    Primary Outcome Measure Information:
    Title
    Scalp photography Microscopic evaluation of hair Trichometry using the HairCheck© device
    Description
    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).
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Global Hair Growth and Global Hair Quality Assessment by investigator Hair Loss Subjective Questionnaire Symptom questionnaire
    Time Frame
    24-weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Women with self-perceived hair loss as confirmed by the investigator.
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Oral Herbal Combination Formulation and Hair Growth in Women

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