A randomized, double blind, active controlled comparative study to assess the efficacy and safety of a Follicles Regen in treatment of excessive hair fall
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.reduction in level of hair fall as measured by trichometer and subject self-assessment records as compared to the comparator
研究概览
简要总结
The study will enrol adultsaged between 18-65 years that have been suffering from excessive hair fall. Eligible participantsscreened in baseline interview (assessment visit 1) will be randomized into twogroups to be treated with either the test product FolliclesRegen oil or comparator.The baseline interview will collect data such as age, level ofdandruff, itching in scalp and Measurements of hair length, hair diameter, andHair Mass Index. Hair Breakage Index and the Healthy Hair Index values will becalculated from the trichometer measurements, and subject self-assessmentquestionnaires. Subjectswill be evaluated on first, second and third month (assessment visits)subsequent to the initiation of treatment. Safety analyses will be done at eachvisit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants must be adults, aged 18-65 years old with complain of excessive hair fall or damage.
- •At screening, subjects must complete questionnaires that would provide investigators with information on their medical and hair health history and demographics.
- •Each subject’s hair length, styled layer length, average hair diameters, Hair Mass Index (HMI), Hair Breakage Index (HBI), and Healthy Hair Index (HHI) readings will be measured, calculated, and recorded.
- •2.Females Subjects must have a negative pregnancy test.
- •Pregnant patients or individual with history of pregnancy will be excluded from the study.
- •3.Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview.
- •4.Participants must be willing to apply the test product and return for assessment visits for evaluation.
- •5.Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or nonprescription medications for hair fall or dandruff treatment.
- •Participants must agree to take healthy diet and life style.
排除标准
- •Single or married subjects who are pregnant or have borne children in past one year.
- •Participants with a history of shampooing hair less than three times a week as part of their current hair care regimen.
- •Participants with a history of illness or fever in past few months OR greater than 20 percent weight loss in the past 12 months OR nutritional deficiency or being on a new diet in the past six months
- •Participants with evidence or history of medical or surgical event in the past year that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders OR thyroid problems OR history of depression or severe anxiety in the past six months.
- •Participants with history of a scalp or hair loss disorder, such as alopecia, in the past 12 months
- •Patients reporting use of prescription or non-prescription drugs during the study period OR Willing to continue the use of their current hair oil.
结局指标
主要结局
1.reduction in level of hair fall as measured by trichometer and subject self-assessment records as compared to the comparator
时间窗: Baseline Day 0 | Day 30 | Day 60 | Day 90
3.Improvement in overall scalp health
时间窗: Baseline Day 0 | Day 30 | Day 60 | Day 90
2.Improvement in the texture, shine and hair length.
时间窗: Baseline Day 0 | Day 30 | Day 60 | Day 90
次要结局
- Safety including documentation of all adverse events, clinically significant and serious adverse events (SAEs)(Baseline Day 0)