A Randomized double-blind placebo-controlled clinical trial to evaluate the safety and efficacy of hair vitamin gummies in reducing hair fall and improving hair and nail health in adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1.Change in the hair density in the target area by phototrichogram at screening visit and end of the study.
研究概览
简要总结
Multiple studies have linked hair loss to negative feelings in both men and women and can contribute to stress, decrease body image satisfaction, diminish quality of life, lowered self-esteem and decreased confidence. Hairs are associated with vitality, virility, and beauty. Hair loss can lead to feelings unattractiveness, age and loss of strength. These effects are more pronounced in men and women who begin losing their hair at an early age. Individual with hair problem, especially thinning and balding is often thought to appear older since in our culture, losing one’s hair signifies getting older. For anyone who suffer from hair loss, regardless of gender, changes in self-esteem and confidence are challenging. It influences how one feel and perceived, both personally and professionally
A Hair loss, formally known as alopecia, can happen for a variety of reasons, including age, hormonal imbalances, high stress levels and untreated medical conditions. A deficiency of nutrition may affect the growth and structure of hair. Micronutrient "shortfalls" can result from inadequate intakes, especially because dietary patterns that are energy-rich diets but void of nutrients. When dietary approaches like dietary modification, fortification, or food provision are unable to achieve adequate intake, vitamin supplements are needed. Vitamin gummies are more palatable, convenient to administer, colorful, and come in a variety of flavors to suit the palate.
The present research is an attempt of clinical validation of vitamin hair gummies in subjects suffering from hair fall, and to improve hair & nail health. With the present clinical trial, we can provide nutrition in easy-to-use form, hassle free gummies to prevent and resolve nutritional deficiencies to get healthy and happy hairs & nails, every day. There is need to come up with a formulation for to promote regrowth of hair to improve scalp coverage, to prevent or slow further hair thinning and loss, treat dandruff and relieve itchy scalp which could be achieved through the present research. We can utilize these outcomes to develop a strategy to achieve healthier, nourished, thicker and stronger hair and nails.
The study has completed and the data is available with the sponsor of the study on individual request basis.
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 35.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female subjects in general good health; 2.Subjects in the age group of 18-35 years (both inclusive); 3.Subjects willing to give a written informed consent and agree to come for a regular follow up visit;
- •Female subjects falling under Grade roman number one-1 to roman number two-1 of Savins pictorial grading of female pattern hair loss or male subjects falling under Grade two to four A of hair loss severity grade evaluated as per Norwood scale; 5.Subject with at least one of the following complaints- •Dry damaged hair •Brittle and thin hair •Hair loss evident while combing or after washing •Perceived reduced hair density •Scalp related complaints like itching, dandruff or irritation.
排除标准
- •1.Subjects who are undergoing hair growth treatment within 3 months before screening into the study; 2.Subjects having any active scalp disease which may interfere in the study; 3.Subjects on treatment for active acne; 4.Subjects with history or active phase of malignancy and chemotherapy; 5.Subjects who have history of alcoholism and/ or psychiatric disorder including trichotillomania; 6.Subjects who have had hair transplant; 7.Subjects who take pharmaceutical product which cause hirsutism; 8.Subjects on oral hair growth medications which will compromise the study; 9.Chronic illness which may influence the study; 10.Subjects participating in other similar cosmetic or therapeutic trial within last two weeks; 11.Pregnant or lactating mothers; 12.Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension (›140/90 mmHg), HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness; 13.Any other condition, as per the discretion of the investigator, that can impact the study outcome or subjects will not be considered in the study.
结局指标
主要结局
1.Change in the hair density in the target area by phototrichogram at screening visit and end of the study.
时间窗: Screening, day 30, day 60 and day 90
2.Change in hair growth rate from screening visit to end of the study.
时间窗: Screening, day 30, day 60 and day 90
3.Change in anagen to telogen ratio (A/T ratio) at screening visit and end of the study.
时间窗: Screening, day 30, day 60 and day 90
次要结局
- 1.Change in the number of terminal hairs, vellus hairs and hair diameter in the target area by phototrichogram at screening visit and end of the study.(2.Change in the number of shredded hairs after “60 Second Hair Comb test†from screening to end of the study.)