Hair LossNCT05019066
Oral Herbal Combination Formulation and Hair Growth in Women
A study testing Herbal Supplementation in people with Hair Loss and Hair Thinning, run by University of California, Davis.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hair Loss, Hair Thinning
- What is being tested?
- Herbal Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
About this study
Official title: 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.
- Conditions
- Hair Loss, Hair Thinning
- Being tested
- Herbal Supplementation
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal SupplementationDietary supplement
A proprietary blend of: Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa.
| Study group | Role | What they receive |
|---|---|---|
| Herbal Combination Group | Active comparator | * 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 Receives: Dietary Supplement: Herbal Supplementation |
| Placebo Group | Placebo comparator | * 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 Receives: Dietary Supplement: Herbal Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 weeks
Secondary outcomes (1)
Global Hair Growth and Global Hair Quality Assessment by investigator Hair Loss Subjective Questionnaire Symptom questionnaire
Measured: 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start30 Sep 2021 (estimated)
- Primary completion22 Feb 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Why it stopped: PI decided not to proceed with study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair LossStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019066
- Sponsor's protocol ID
- 1396273
- Status last verified
- Oct 2021
- First submitted
- 4 Aug 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Oral Herbal Combination Formulation on Hair Growth in Women With Self-perceived Hair Loss
- ClinicalTrials.gov ID
- NCT05019066
- Acronym / sponsor ID
- 1396273
- Conditions
- Hair Loss, Hair Thinning
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decided not to proceed with study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 30 Sep 2021 (estimated)
- Primary completion
- 22 Feb 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Herbal Combination Group | Active comparator | Dietary Supplement: Herbal Supplementation* 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 |
| Placebo Group | Placebo comparator | Dietary Supplement: Herbal Supplementation* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal SupplementationA proprietary blend of: Eclipta alba, Emblica officinalis, Centella asiatica and Hibiscus sabdariffa. | Dietary supplement | Herbal Combination Group, Placebo Group |
Primary outcome
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).
1 secondary outcome
Global Hair Growth and Global Hair Quality Assessment by investigator Hair Loss Subjective Questionnaire Symptom questionnaire
Time frame: 24-weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Herbal Supplementation in people with Hair Loss and Hair Thinning, run by University of California, Davis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scalp photography Microscopic evaluation of hair Trichometry using the HairCheck© device (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.