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
- 99
- 试验地点
- 1
- 主要终点
- change in GSS score by using CASLite Nova
研究概览
简要总结
This is proof-of-science, prospective, interventional, three-arm, double-blind, randomized, safety and efficacy real world evidence study of herbal and non herbal formulations in healthy human subjects having complaint of hair fall and pre-mature graying.
详细描述
Considering the clinical safety, efficacy study a sufficient number 99 subjects (33 subject/arm) will be enrolled to 90 subjects (30 subject/arm) completed the study. In each arm, fifteen (15) participants per group will be recruited, with one group consisting of individuals experiencing mild to moderate Androgenetic Alopecia (AGA) class 1, 2, 3, while the other group will comprise fifteen (15) healthy subjects with symptoms of hair loss and premature graying. The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. The adult female/male subjects will be instructed to visit the facility as per the below visits.
- Visit 01 (Day -04): Screening, Tattoo creation, Hair Growth Rate measurement
- Visit 02 (Day 01): Enrolment, Hair Growth Rate measurement, All evaluations
- Visit 03 (Day 45 (±2 days)): Treatment Phase
- Visit 04 (Day 87 (±2 days)): Treatment Phase, Tattoo creation, Hair Growth Rate measurement Visit 05 (Day 90 (3 days from visit 04): Hair Growth Rate measurement, All evaluations
- Visit 06: (Day 120 (±2 days)): End of Treatment Phase, All evaluations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
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 beconsidered 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.
- •Willing to use test products throughout the study period.
- •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.
- •Subject must be able to understand and provide written informed consent to participate in the study
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 participated any clinical research study related to hair care products.
- •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.
研究组 & 干预措施
Polyherbal Hair Oil
Apply oil with the help of fingertips on your scalp and massage it gently enabling it to penetrate into the roots (follicle) of your hair. Don't apply with your palms and never rub it vigorously as it may uproot weak hair. Let the oil gradually seep into follicle of your hair & nourish them for the whole night. The oil may be removed in the morning by washing of hair with Ayurvedic Shampoo.
Dosage form: Liquid Frequency: Three times a week Route of Administration: Topical
干预措施: Polyherbal Hair Oil (Other)
Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair Serum
First, apply the herbal hair oil generously to your scalp and hair, ensuring thorough coverage. Gently massage it in with your fingertips to promote circulation and absorption. After the oil application, follow the instructions provided for the application of the minoxidil hair serum. Apply the serum to the areas of your scalp where you desire hair growth, using the dropper provided or as directed. Massage it gently into your scalp to ensure even distribution and absorption. Leave the serum on without rinsing Frequency: For Minoxidil - Daily Night Application For Herbal Hair Oil- Thrice a week Route of Administration: Topical
干预措施: Minoxidil Herbal Hair Oil + Minoxidil 5 (%) Hair Serum (Other)
Minoxidil Hair Serum
Apply the amount prescribed to the area of the scalp being treated, beginning in the center of the area. Frequency: Daily Night Application of Minoxidil Route of Administration: Topical
干预措施: Minoxidil Hair Serum (Other)
结局指标
主要结局
change in GSS score by using CASLite Nova
时间窗: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 120 (+2 days)
To assess the effectiveness of the test products in terms of change in GSS score
change in hair density by using CASLite Nova
时间窗: Baseline before usage of test product on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120
To assess the effectiveness of the test products in terms of hair density by using CASLite Nova.
change in hair fall by using 60 second hair combing test.
时间窗: Baseline before usage of the test products (04 days before Day 01) and after usage of the test on Day 45, Day 90 and Day 120.
To assess the effectiveness of the test products in terms of change in hair fall by using 60 second hair combing test.
change in scalp skin hydration by using Corneometer CM 825
时间窗: 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
To assess the effectiveness of the test products in terms of change in scalp skin hydration
change in hair strength by using hair pull test.
时间窗: Baseline before usage of the test products (04 days before Day 01) and after usage of the test on Day 45, Day 90 and Day 120
To assess the effectiveness of the test products in terms of change in hair strength by using hair pull test
change in Anagen: Telogen (A: T) Ratio by using Hair Pluck Test by dermatologist.
时间窗: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 120
To assess the effectiveness of the test products in terms of change in Anagen: Telogen (A: T) Ratio
change in hair thickness by using CASLite Nova
时间窗: Baseline before usage of test product on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120
To assess the effectiveness of the test products in terms of change in hair thickness by using CASLite Nova.
change in hair growth rate by using CASLite Nova
时间窗: 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 .
To assess the effectiveness of the test products in terms of change in hair growth rate by using CASLite Nova
change in ASFS by using ASFS scoring scale.
时间窗: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45 (+2 days), Day 90 (3 days from the visit 04) and Day 120 (+2 days)
To assess the effectiveness of the test products in terms of change in ASFS where 0-10 scale (0 means no flakes and 10 means heavy flaking)
次要结局
- change in lipid deposition of the hair by using XRF method(Baseline on Day 1 and post application of the test products at 120 Days)
- change in damage repair of the hair by using SEM analysis(Baseline on Day 1 and post application of the test products at 120 Days)
- change in general appearance of hair(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.)
- change in general appearance of scalp.(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.)
- change in digital photographs of the head crown Nikon digital camera D3300(Before usage of the test products on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120.)
- change in products perception questionnaire by using 5-point Likert scale(Before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120)
- sensorial evaluation on the hair tress by 6 expert evaluation.(Baseline and post application of the test products on Day 1 at T 60 minutes)
- change in hair shine using glossymeter GL 200(Baseline and post application of the test products on Day 1 at T 60 minutes)