A clinical study to check the safety and effectiveness of plant-based Biotin and plant-based Biotin with Silica in Healthy Human who had complaints of hair fall, thin dry and brittle hair and dry ski
- Registration Number
- CTRI/2023/07/055359
- Lead Sponsor
- ORGENETICS INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 105
1)Age: 20 to 60 years (both inclusive) at the time of consent.
2)Sex: Healthy males and non-pregnant/non-lactating females.
3)Subject have complaints of hair fall, thin, dry and brittle hair, and dry skin.
4)Females of childbearing potential must have a reported negative pregnancy test.
5)Subject are generally in good health.
6)Subject must have negative Hepatitis B Surface Antigen Test at baseline.
7)Subject with self-proclaimed nonpathological thin, dry and brittle hair.
8)Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
9)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.
10)Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
11)Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.
12)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.
13)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.
14)Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study.
15)Subjects are willing to give written informed consent and are willing to follow the study procedure.
16)Subjects who have used other marketed products for hair thinning in the past.
17)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.
18)Willing to use test treatments throughout the study period.
1)Subjects with a history of hair thinning/hair fall due to any clinically significant self-reported problems/s like anaemia, thyroid problems, etc.
2)Subject has a history of allergy or sensitivity to the test treatment ingredients.
3)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.).
4)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.
5)Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
6)Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
7)Subject is currently pregnant/breastfeeding.
8)Subject has a history of prior use of hair growth treatment within 3 months.
9)Subject has a history of any prior hair growth procedures (e.g., hair transplant or laser).
10)Subject has a history of alcohol or drug addiction.
11)Subjects who have plans of shaving scalp hair during the study.
12)Subject has a past or present condition of irritated or visibly inflamed scalp or severe scalp disease.
13)Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
14)Pregnant or breastfeeding or planning to become pregnant during the study period.
15)History of chronic illness which may influence the cutaneous state.
16)Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials or hair/scalp/skin care products within the last four weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effectiveness of the test treatments in terms of <br/ ><br>1. Change in hair fall <br/ ><br>2. Change in hair thickness & density <br/ ><br>3.Change in hair growth rate on the scalp <br/ ><br>4. Change in PGA scores for sign of brittle nails, surface roughness, raggedness & peeling. <br/ ><br>Timepoint: Baseline (Day01) to Day 30, Day 60 & Day 90, between treatments, within treatment & compare with placebo treated <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method