A prospective multicenter post marketing observational study to evaluate the effectiveness of an oral multivitamin and multimineral supplement also containing amino acids in patients with hair loss telogen effluvium
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- To evaluate the effectiveness of the treatment with oral nutritional supplements in reducing hair loss at 12 weeks using hair pull test
研究概览
简要总结
This is a prospective multicenter post marketing observational study to evaluate
the effectiveness of an oral multivitamin and multimineral supplement also
containing amino acids in patients with hair loss telogen effluvium with age group
18 to 60 years This multicenter study will enrol approximately 200 patients with
telogen effluvium The patients will be followed up for 3 months after enrolment
The enrolment of patients for the study will be based on the approved protocol by
the local ethics committee All the patients with a clinical diagnosis of telogen
effluvium, meeting all inclusion and none of the exclusion criteria, and ready to
give informed consent for study participation, are eligible for participation in this
observational study The study is planned to be conducted for approximately 12
months.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and Female patients aged 18 to 60 years diagnosed with Telogen Effluvium by a dermatologist Willingness and ability to provide informed consent for participation in the study Agreement to comply with the prescribed Follihair AM PM and attend scheduled follow up assessments during the study period.
排除标准
- •Pregnancy or lactation, as hormonal changes during these periods can influence hair health Use of contraceptive medications with known hormonal effects that could affect hair growth Diagnosed with Androgenetic alopecia Concomitant use of drugs that cause hair loss as per dermatologist’ discretion Use of hair growth medications or treatments within the last 6 months, which may confound the study results as per treating dermatologist’s discretion Use of nutritional supplements for hair loss in the last 3 months as per dermatologist’s discretion Any known history of allergies or adverse reactions to the components of the study products- similar products as per dermatologist’s discretion Current participation in other clinical trials involving hair health or dermatological treatments Any other medical conditions that could impact hair health as per dermatologist’s discretion History of major surgical procedures or significant trauma in the last 6 months.
结局指标
主要结局
To evaluate the effectiveness of the treatment with oral nutritional supplements in reducing hair loss at 12 weeks using hair pull test
时间窗: Baseline and 12 weeks
次要结局
- To evaluate the effectiveness of treatment with oral nutritional(supplements in reducing hair loss at 12 weeks using global assessment score the GAS a 7 point score from minus 3 severe worsening to plus 3 excellent)
研究者
Dr Shehnaz Arsiwala
Renewderm Skin Hair Laser Aesthetics Centre