Scientific evaluation of the safety and efficacy of herbal and non-herbal formulations in mitigating hair fall, promoting hair growth, and preventing premature hair graying.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of the test products in terms of change in
研究概览
简要总结
Scientific Evaluation of the Safety and Efficacy of Herbal and Non-Herbal Formulations in Mitigating Hair Fall, Promoting Hair Growth, and Preventing Premature Hair Greying.
A sufficient number of 78 subjects will be enrolled to 75 complete the study. There are total 6 visits in the study.
- Visit 01:Screening, Tattoo creation, Hair Growth Rate measurement
- Visit 02: Enrolment, Hair Growth Rate measurement, All evaluations
- Visit 03: Treatment Phase
- Visit 04: Treatment Phase, Tattoo creation, Hair Growth Rate measurement
- Visit 05: Hair Growth Rate measurement, All evaluations
- Visit 06: End of Treatment Phase, All evaluations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18 to 55 years and above (both inclusive) at the time of consent.
- •Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- •Females of childbearing potential must have a self-reported negative urine pregnancy.
- •Subject is in good general health as determined by the Investigator on the basis of medical history.
- •Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
- •Subject having AGA and premature Gray hair at a time of screening.
- •Subject having premature gray hair at a time of screening.
- •Subject with pro-claimed nonpathological thinning of hair.
- •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.
- •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.
- •Subjects are willing to give written informed consent and are willing to follow the study procedure.
- •Subjects who commit not to use any other medicated/ prescription shampoos/hair care products (containing Minoxidil), any other hair growth products or hair colour or dye, other than the test products for the entire duration of the study.
- •Subject is willing and able to follow and allow study staff to performed study test methods.
- •Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
排除标准
- •Subject have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
- •Subject have history of any dermatological condition of the scalp other than hair loss and dandruff.
- •Subject have history of any prior hair growth procedures (e.g. hair transplant or laser).
- •Subject who had taken topical treatment of hair loss for at least 4 weeks.
- •Subject who had taken any systemic treatment for at least 3 months.
- •History of alcohol or drug addiction.
- •Subject having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
- •Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study.
- •Pregnant or breast feeding or planning to become pregnant during the study period.
- •History of chronic illness which may influence the cutaneous state.
- •Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
结局指标
主要结局
To evaluate the effectiveness of the test products in terms of change in
时间窗: From baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120 | for pluck test and GSS score - from baseline before usage of the test products on Day 01 and after usage of the test products on Day 120
1.hair thickness, hair density and scalp condition, hair strength, scalp skin hydration, ASFS score
时间窗: From baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120 | for pluck test and GSS score - from baseline before usage of the test products on Day 01 and after usage of the test products on Day 120
2.hair growth rate
时间窗: From baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120 | for pluck test and GSS score - from baseline before usage of the test products on Day 01 and after usage of the test products on Day 120
3.hair fall
时间窗: From baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120 | for pluck test and GSS score - from baseline before usage of the test products on Day 01 and after usage of the test products on Day 120
4.A:T ratio
时间窗: From baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120 | for pluck test and GSS score - from baseline before usage of the test products on Day 01 and after usage of the test products on Day 120
5.GSS score
时间窗: From baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120 | for pluck test and GSS score - from baseline before usage of the test products on Day 01 and after usage of the test products on Day 120
次要结局
- 1.To evaluate the effectiveness of the test products in terms of change in general appearance of hair like hair volume, air plasticity, hair density, hair shininess, hair smoothness, hair oiliness from baseline before and after usage of the test products and between the test products.(from baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120 by dermatologist and dermatologist trained evaluator and also compare with the between test products.)
- 2.To evaluate the effectiveness of the test products in terms of change in general appearance of scalp like Itchiness, redness, roughness, and scaliness from baseline before and after usage of the test products and between the test products.(from baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120 by dermatologist or dermatologist trained evaluator and also compare with the between test products.)
- 3.To evaluate the effectiveness of the test products in terms of change in digital photographs of the head crown from baseline before and after usage of the test products and between the test products.(from before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120 by using Nikon digital camera D3300 and also compare the between test products and also compare with the between test products.)
- 4.To evaluate the effectiveness of the test products in terms of product perception questionnaire from the baseline before and after usage of the test products and between the test products.(before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120 by using 5-point Likert scale and also compare with the between test products)
- To evaluation effect of the test product in terms of change in hair sensorial parameter at different time points through the 6-expert panel.(Before and after usage of test products on Day 01.)
- To evaluate the effectiveness of the test products in terms of change in shine of the hair after usage of the test products at different time points.(Before and after usage of test products on Day 01.)
- To evaluate the effectiveness of the test products in terms of change in damage repair from baseline before and after usage of the test products and between the test products.(Before and after usage of test products on Day 01.)
- To evaluate the effectiveness of the test products in terms of change in lipid deposition through the XRF method.(Before and after usage of test products on Day 01.)
研究者
Maheshvari Patel
NovoBliss Research Private Limited