CTRI/2023/07/055359已完成Unknown
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 - NI
ORGENETICS INC0 个研究点目标入组 105 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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