Hair FallingNCT05972512
A Clinical Study to Assess the Safety and Effectiveness of Plant-based Biotin and Plant Based Biotin with Silica in Healthy Human Subjects with Complaints of Hair Fall, Thin, Dry, & Brittle Hair, and Dry Skin
A study testing Botanical extract of standardized biotin and Botanical extract of standardised biotin with silica in people with Hair Falling and Thin Hair, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
A randomized, double-blind, three-arm, placebo-controlled, safety, and efficacy study of plant-based Biotin and plant-based Biotin with Silica in healthy adult human subjects with complaints of hair fall, thin, dry, and brittle hair, and dry skin. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hair Falling, Thin Hair, Dry Hair
- What is being tested?
- Botanical extract of standardized biotin and Botanical extract of standardised biotin with silica
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteIndia
- Study dates
- 22 Aug 2023to 14 Dec 2023
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20 to 60 years (both inclusive) at the time of consent
- Sex: Healthy males and non-pregnant/non-lactating females.
- Subject have complaints of hair fall, thin, dry and brittle hair, and dry skin.
- Females of childbearing potential must have a reported negative pregnancy test.
- Subject are generally in good health.
- Subject must have negative Hepatitis B Surface Antigen Test at baseline.
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- Subject with self-proclaimed nonpathological thin, dry and brittle hair.
- Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
- Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
- Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
- Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.
- If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
- Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study.
- Subjects are willing to give written informed consent and are willing to follow the study procedure.
- Subjects who have used other marketed products for hair thinning in the past.
- Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-thinning agents) or any other hair growth, treatment for thin hair, or hair products other than the test treatments for the entire duration of the study.
- Willing to use test treatments throughout the study period.
Who cannot join
- Subjects with a history of hair thinning/hair fall due to any clinically significant self-reported problems/s like anaemia, thyroid problems, etc.
- Subject has a history of allergy or sensitivity to the test treatment ingredients.
- Subject has a history of any dermatological condition of the scalp other than hair loss and/or dandruff or active dermatological condition that might interfere with the clinical assessments (e.g. tattoos, eczema, psoriasis, acne, etc.).
- Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
- Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
- Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
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- Subject is currently pregnant/breastfeeding.
- Subject has a history of prior use of hair growth treatment within 3 months.
- Subject has a history of any prior hair growth procedures (e.g., hair transplant or laser).
- Subject has a history of alcohol or drug addiction.
- Subjects who have plans of shaving scalp hair during the study.
- Subject has a past or present condition of irritated or visibly inflamed scalp or severe scalp disease.
- Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
- Pregnant or breastfeeding or planning to become pregnant during the study period.
- History of chronic illness which may influence the cutaneous state.
- Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials or hair/scalp/skin care products within the last four weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Safety, and Efficacy Study of Plant Based Biotin and Plant Based Biotin with Silica in Healthy Adult Human Subjects with Complaints of Hair Fall Thin, Dry, & Brittle Hair, and Dry Skin
A randomized, double-blind, three-arm, placebo-controlled, safety, and efficacy study of plant-based Biotin and plant-based Biotin with Silica in healthy adult human subjects with complaints of hair fall, thin, dry, and brittle hair, and dry skin.
A sufficient number (maximum of 105 (35 subject/test treatment)) of female/male adult subjects will be recruited/enrolled to ensure a total of 96 subjects (32 subjects/test treatment) complete the study.
Read the detailed description
The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. Total study visits will be 8 during this study.
Visit 01 (Within 30 Days): Screening procedure, Informed consent obtain process, baseline evaluations, blood collection, tattoo on scalp, hair growth rate measurement Visit 02 (Day 01): Enrolments, hair growth rate measurement, other evaluations, product distribution, diary distribution, AE reporting (if any.
Visit 03 (Day 27 +2 Days): Treatment period, evaluations, tattoo, hair growth rate measurement, diary card review, AE reporting (if any).
Visit 04 (3 Days from Visit 03): Treatment period, evaluations, diary card review, AE Reporting (if any).
Visit 05 (Day 57 + 2Days): Treatment period, evaluations, tattoo, hair growth rate measurement, diary card review, AE Reporting (if any).
Visit 06 (3 Days from Visit 05): Treatment period, evaluations, diary card review, AE Reporting (if any).
Visit 07 (Day 87 +2 Days): Treatment period, evaluations, tattoo, hair growth rate measurement, diary card review, AE Reporting (if any).
Visit 08 (3 days from Visit 08): Evaluations, dairy card collection, AE reporting, test treatments accountability, End of Study process.
done on Day 04 before Day 01, Day 01 and after test treatment usage will be done on Day 27, Day 30, Day 57, Day 60, Day 87, Day 90 as listed-below.
- 60-S Hair Combing Method: Hair Fall.
- CASALite Nova (Phototrichogram): Hair Density, Thickness, Hair Growth Rate, Scalp Condition.
- PGA Score: Signs of brittle nails, surface roughness, raggedness and peeling.
- Visioscan®VC 20plus (C+K Instrument): Crow's feet area wrinkles, fine lines, skin texture - roughness, dryness, wrinkles, smoothness (Right cheek).
- MoitureMeterEPiD: Skin hydration (Right cheek).
- Hair Pull Test: Hair strength.
- Pluck Test: A:T ratio (Hair Growth Cycle)
- Cutometer: Skin elasticity (Right cheek).
- PGA Griffith Scale: Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness
- Tewameter® TM 300: Skin barrier function (Right Cheek)
- General Appearance of Hair: Hair shininess, hair reflection, hair plasticity, hair fizziness, hair volume, hair density Digital photographs: Facial photographs before test treatment consumption and after test treatment consumption
- Blood parameters: CBC, total Serum Cholesterol, Triglyceride, Random Glucose, LDL, HDL [Note: blood collection will be performed on Day 01 And Day 90]
- Blood parameter: HBsAg (Hepatitis B surface antigen) - Screening only
- Subjective product perception assessment regarding the test treatment's effect on skin elasticity, suppleness, skin color, fragrance, taste, skin hydration, skin tone, firmness, appearance, hair and nails, strongness and shine.
- Conditions
- Hair Falling, Thin Hair, Dry Hair, Brittle Hair, Dry Skin
- Being tested
- Placebo, Botanical extract of standardized biotin, Botanical extract of standardised biotin with silica
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Mode of usage: Two times a day Route of administration: Oral
Botanical extract of standardized biotinDietary supplement
Mode of usage: Two times a day Route of administration: Oral
Botanical extract of standardised biotin with silicaDietary supplement
Mode of usage: Two times a day Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The test treatment will be taken two times a day. Receives: Other: Placebo |
| Botanical Extract of standardised for biotin (1250 mcg) | Experimental | The standardised botanical extract of biotin is specially formulated for healthier hair and skin. Biotin promotes the hair growth. Receives: Dietary Supplement: Botanical extract of standardized biotin |
| Botanical Extract of standardised for biotin (1250mcg) + 10 mg Silica | Experimental | The standardised botanical extract of biotin and silica is specially formulated for healthier hair. The combination of biotin and silica will helpful in hair growth, reduces shedding, and improves the health of hair. Receives: Dietary Supplement: Botanical extract of standardised biotin with silica |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hair fall
To assess the effectiveness of test treatment in terms of change in hair fall by using 60-s hair comb test
Measured: Baseline (Day 01) before dosing to Day 30, Day 60, Day 90 post-dose, between treatments, within treatment and compare with placebo arm
Change in hair thickness (Unit= µm)
To assess the effectiveness of test treatment in terms of change in hair thickness by CASALite Nova thorough Phototrichogram
Measured: From baseline (Day 01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo arm
Change in hair growth rate (Unit= µm)
To assess the effectiveness of test treatment in terms of change in hair growth rate by using CASALite Nova thorough Phototrichogram
Measured: From screening (Within 4 Day) to Day 01, Day 27, Day 30, Day 57, Day 60, Day 87 and Day 90 post-dose, between treatment, within treatment, and compare with placebo arm
Change in PGA score for sign of brittle nails
To assess the effectiveness of test treatment in terms of change in PGA score for sign of brittle nails by using 5-point scoring scale Where 0= None and 5= Severe
Measured: Baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in Hair Density (Unit= sqcm)
- assess the effectiveness of test treatment in terms of change in hair density by using CASALite Nova thorough phototrichogram
Measured: rom baseline (Day 01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo arm
Change in PGA score for sign of Nail Surface Roughness
To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface roughness by using 3 point scoring scale Where 0= None, 3= Severe
Measured: From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in PGA score for sign of Surface Raggedness
To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface raggedness by using 3 point scoring scale Where 0= None, 3= Severe
Measured: From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in PGA score for sign of Peeling
To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface peeling by using 4 point scoring scale where 0= none, 3= severe
Measured: From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Secondary outcomes (19)
Change in facial wrinkle
To assess the effectiveness of test treatment in terms of change in facial wrinkles by using Visioscan VC 20plus (Instrumental Evaluation)
Measured: From baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
Change in fine lines of crow's feet area,
To assess the effectiveness of test treatment in terms of change in fine lines of crow's feet area by using Visioscan VC 20plus (Instrumental Evaluation)
Measured: from baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
Change in skin hydration
To assess the effectiveness of test treatment in terms of change in skin hydration by using MoistureMeterEpiD (Instrumental Evaluation)
Measured: from baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
Change in hair Strength
To assess the effectiveness of test treatment in terms of change in hair strength by using hair pull test
Measured: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in skin elasticity
To assess the effectiveness of test treatment in terms of change in skin elasticity by using Cutometer Dual MPA 580(Instrumental Evaluation)
Measured: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in PGA Score
To assess the effectiveness of test treatment in terms of change in PGA scores i.e. dryness, redness, fine lines, coarse wrinkle, laxity, roughness, and sallowness by using Griffith scale Where 0= No appearance and 9= Severe
Measured: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in barrier function of skin
To assess the effectiveness of test treatment in terms of change in barrier function of skin by using Tewameter TM Hex(Instrumental Evaluation)
Measured: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in general appearance of hair
To assess the effectiveness of test treatment in terms of change in general appearance of hair such as hair shininess, hair reflection, hair volume, hair density, hair plasticity, hair frizziness by dermatologist trained evaluator
Measured: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in Anagen: Telogen ratio
To assess the effectiveness of test treatment in terms of change in Anagen: Telogen ratio of hair by using hair pluck test
Measured: From baseline (Day01) to Day 90 (+2Days), between treatments, within treatment and compare with placebo treated arm
Change in facial photographs(Left/Center/Right)
Change in facial photographs (Left/Center/Right) of the subject by using Nikol Digital Camera D3300
Measured: From baseline before usage of test treatments on Day 01, and after usage of test treatments on Day 30, Day 60, Day 90
Treatment perception questionnaire
To assess the effectiveness of test treatment in terms of treatment perception by using 9 point hedonic scale
Measured: From before dosing of test treatments to after usage of test treatments on Day 30, Day 60, Day 90
Change in Complete Blood Count
Safety of test treatment will be assessed in terms of difference in Complete Blood Count
Measured: From Day 01 and Day 90
Change in silicon deposits on hair cuticle
To assess the effect of test treatments in terms of change silicon deposits on hair cuticle by using Scanning Electrone Microscope (8 subject/ test treatment)
Measured: From baseline (Day01) before dosing to Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in Skin Texture
To assess the effectiveness of test treatment in terms of change in Skin texture by using Visioscan VC 20plus
Measured: From baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
Change in Total Serum Cholesterol
Safety of test treatment will be assessed in terms of difference in Total Serum Cholesterol level
Measured: From Day 01 and Day 90
Change in Triglycerides
Safety of test treatment will be assessed in terms of difference in Triglycerides level
Measured: From Day 01 and Day 90
Change in LDL level
Safety of test treatment will be assessed in terms of difference in LDL level
Measured: From Day 01 and Day 90
Change in HDL level
Safety of test treatment will be assessed in terms of difference in HDL level
Measured: From Day 01 and Day 90
Change in Random Glucose Level
Safety of test treatment will be assessed in terms of difference in Random Glucose Level
Measured: From Day 01 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start22 Aug 2023
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair FallingStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Double-Blind, Placebo-Controlled, Safety, and Efficacy Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Orgenetics, Inc.
- Responsible party
- Principal investigator, Dr Nayan Patel, NovoBliss Research Pvt Ltd
- Investigators
- Dr Nayan K Patel, Principal investigator, Medical Direcor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972512
- Sponsor's protocol ID
- NB230019-OI
- Status last verified
- Nov 2023
- First submitted
- 7 Jul 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Safety, and Efficacy Study of Plant Based Biotin and Plant Based Biotin with Silica in Healthy Adult Human Subjects with Complaints of Hair Fall Thin, Dry, & Brittle Hair, and Dry Skin
- ClinicalTrials.gov ID
- NCT05972512
- Acronym / sponsor ID
- NB230019-OI
- Conditions
- Hair Falling, Thin Hair, Dry Hair, Brittle Hair, Dry Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Orgenetics, Inc.
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 2 Aug 2023 (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.
A randomized, double-blind, three-arm, placebo-controlled, safety, and efficacy study of plant-based Biotin and plant-based Biotin with Silica in healthy adult human subjects with complaints of hair fall, thin, dry, and brittle hair, and dry skin.
A sufficient number (maximum of 105 (35 subject/test treatment)) of female/male adult subjects will be recruited/enrolled to ensure a total of 96 subjects (32 subjects/test treatment) complete the study.
Detailed description
The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. Total study visits will be 8 during this study.
Visit 01 (Within 30 Days): Screening procedure, Informed consent obtain process, baseline evaluations, blood collection, tattoo on scalp, hair growth rate measurement Visit 02 (Day 01): Enrolments, hair growth rate measurement, other evaluations, product distribution, diary distribution, AE reporting (if any.
Visit 03 (Day 27 +2 Days): Treatment period, evaluations, tattoo, hair growth rate measurement, diary card review, AE reporting (if any).
Visit 04 (3 Days from Visit 03): Treatment period, evaluations, diary card review, AE Reporting (if any).
Visit 05 (Day 57 + 2Days): Treatment period, evaluations, tattoo, hair growth rate measurement, diary card review, AE Reporting (if any).
Visit 06 (3 Days from Visit 05): Treatment period, evaluations, diary card review, AE Reporting (if any).
Visit 07 (Day 87 +2 Days): Treatment period, evaluations, tattoo, hair growth rate measurement, diary card review, AE Reporting (if any).
Visit 08 (3 days from Visit 08): Evaluations, dairy card collection, AE reporting, test treatments accountability, End of Study process.
done on Day 04 before Day 01, Day 01 and after test treatment usage will be done on Day 27, Day 30, Day 57, Day 60, Day 87, Day 90 as listed-below.
- 60-S Hair Combing Method: Hair Fall.
- CASALite Nova (Phototrichogram): Hair Density, Thickness, Hair Growth Rate, Scalp Condition.
- PGA Score: Signs of brittle nails, surface roughness, raggedness and peeling.
- Visioscan®VC 20plus (C+K Instrument): Crow's feet area wrinkles, fine lines, skin texture - roughness, dryness, wrinkles, smoothness (Right cheek).
- MoitureMeterEPiD: Skin hydration (Right cheek).
- Hair Pull Test: Hair strength.
- Pluck Test: A:T ratio (Hair Growth Cycle)
- Cutometer: Skin elasticity (Right cheek).
- PGA Griffith Scale: Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness
- Tewameter® TM 300: Skin barrier function (Right Cheek)
- General Appearance of Hair: Hair shininess, hair reflection, hair plasticity, hair fizziness, hair volume, hair density Digital photographs: Facial photographs before test treatment consumption and after test treatment consumption
- Blood parameters: CBC, total Serum Cholesterol, Triglyceride, Random Glucose, LDL, HDL [Note: blood collection will be performed on Day 01 And Day 90]
- Blood parameter: HBsAg (Hepatitis B surface antigen) - Screening only
- Subjective product perception assessment regarding the test treatment's effect on skin elasticity, suppleness, skin color, fragrance, taste, skin hydration, skin tone, firmness, appearance, hair and nails, strongness and shine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A Randomized, Double-Blind, Placebo-Controlled, Safety, and Efficacy Study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboThe test treatment will be taken two times a day. |
| Botanical Extract of standardised for biotin (1250 mcg) | Experimental | Dietary Supplement: Botanical extract of standardized biotinThe standardised botanical extract of biotin is specially formulated for healthier hair and skin. Biotin promotes the hair growth. |
| Botanical Extract of standardised for biotin (1250mcg) + 10 mg Silica | Experimental | Dietary Supplement: Botanical extract of standardised biotin with silicaThe standardised botanical extract of biotin and silica is specially formulated for healthier hair. The combination of biotin and silica will helpful in hair growth, reduces shedding, and improves the health of hair. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Age: 20 to 60 years (both inclusive) at the time of consent
- Sex: Healthy males and non-pregnant/non-lactating females.
- Subject have complaints of hair fall, thin, dry and brittle hair, and dry skin.
- Females of childbearing potential must have a reported negative pregnancy test.
- Subject are generally in good health.
Key exclusion criteria (16 listed)
- Subjects with a history of hair thinning/hair fall due to any clinically significant self-reported problems/s like anaemia, thyroid problems, etc.
- Subject has a history of allergy or sensitivity to the test treatment ingredients.
- Subject has a history of any dermatological condition of the scalp other than hair loss and/or dandruff or active dermatological condition that might interfere with the clinical assessments (e.g. tattoos, eczema, psoriasis, acne, etc.).
- Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
- Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during 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 |
|---|---|---|
| PlaceboMode of usage: Two times a day Route of administration: Oral | Other | Placebo |
| Botanical extract of standardized biotinMode of usage: Two times a day Route of administration: Oral | Dietary supplement | Botanical Extract of standardised for biotin (1250 mcg) |
| Botanical extract of standardised biotin with silicaMode of usage: Two times a day Route of administration: Oral | Dietary supplement | Botanical Extract of standardised for biotin (1250mcg) + 10 mg Silica |
Primary outcome
Change in hair fall
Time frame: Baseline (Day 01) before dosing to Day 30, Day 60, Day 90 post-dose, between treatments, within treatment and compare with placebo arm
To assess the effectiveness of test treatment in terms of change in hair fall by using 60-s hair comb test
Change in hair thickness (Unit= µm)
Time frame: From baseline (Day 01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo arm
To assess the effectiveness of test treatment in terms of change in hair thickness by CASALite Nova thorough Phototrichogram
Change in hair growth rate (Unit= µm)
Time frame: From screening (Within 4 Day) to Day 01, Day 27, Day 30, Day 57, Day 60, Day 87 and Day 90 post-dose, between treatment, within treatment, and compare with placebo arm
To assess the effectiveness of test treatment in terms of change in hair growth rate by using CASALite Nova thorough Phototrichogram
Change in PGA score for sign of brittle nails
Time frame: Baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
To assess the effectiveness of test treatment in terms of change in PGA score for sign of brittle nails by using 5-point scoring scale Where 0= None and 5= Severe
Change in Hair Density (Unit= sqcm)
Time frame: rom baseline (Day 01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo arm
o assess the effectiveness of test treatment in terms of change in hair density by using CASALite Nova thorough phototrichogram
Change in PGA score for sign of Nail Surface Roughness
Time frame: From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface roughness by using 3 point scoring scale Where 0= None, 3= Severe
Change in PGA score for sign of Surface Raggedness
Time frame: From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface raggedness by using 3 point scoring scale Where 0= None, 3= Severe
Change in PGA score for sign of Peeling
Time frame: From baseline (Day 01) before dosing of test treatments to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
To assess the effectiveness of test treatment in terms of change in PGA score for sign of nail surface peeling by using 4 point scoring scale where 0= none, 3= severe
19 secondary outcomes
Change in facial wrinkle
Time frame: From baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
Change in fine lines of crow's feet area,
Time frame: from baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
Change in skin hydration
Time frame: from baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
Change in hair Strength
Time frame: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in skin elasticity
Time frame: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in PGA Score
Time frame: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in barrier function of skin
Time frame: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in general appearance of hair
Time frame: From baseline (Day01) before dosing to Day 30, Day 60 and Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in Anagen: Telogen ratio
Time frame: From baseline (Day01) to Day 90 (+2Days), between treatments, within treatment and compare with placebo treated arm
Change in facial photographs(Left/Center/Right)
Time frame: From baseline before usage of test treatments on Day 01, and after usage of test treatments on Day 30, Day 60, Day 90
Treatment perception questionnaire
Time frame: From before dosing of test treatments to after usage of test treatments on Day 30, Day 60, Day 90
Change in Complete Blood Count
Time frame: From Day 01 and Day 90
Change in silicon deposits on hair cuticle
Time frame: From baseline (Day01) before dosing to Day 90 post-dose, between treatments, within treatment and compare with placebo treated arm
Change in Skin Texture
Time frame: From baseline (Day01) to Day 30, Day 60 and Day 90, between treatments, within treatment and compare with placebo treated arm
Change in Total Serum Cholesterol
Time frame: From Day 01 and Day 90
Change in Triglycerides
Time frame: From Day 01 and Day 90
Change in LDL level
Time frame: From Day 01 and Day 90
Change in HDL level
Time frame: From Day 01 and Day 90
Change in Random Glucose Level
Time frame: From Day 01 and Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Dr Nayan K Patel principal investigator
Medical Direcor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botanical extract of standardized biotin and Botanical extract of standardised biotin with silica in people with Hair Falling and Thin Hair, run by NovoBliss Research Pvt Ltd at 1 site in India.
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 18 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: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in hair fall (time frame: Baseline (Day 01) before dosing to Day 30, Day 60, Day 90 post-dose, between treatments, within treatment and compare with placebo arm). The study lists 8 primary outcomes in all. 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 3 Mar 2025.