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临床试验/NCT03659201
NCT03659201已完成4 期

Randomized Clinical Trial, Placebo Controlled and Active Comparator, to Evaluate Efficacy and Safety of Neosil in Chronic Effluvium

EMS1 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2018年9月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
232
试验地点
1
主要终点
Hair density

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of Neosil in the treatment of chronic effluvium

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants who present hair loss for more than 6 months;
  • Do not use other possible cosmetic or dermatological treatments, during the trial;
  • Not change the diet during the trial and not be any restrictive diet during this period.

排除标准

  • Pregnancy or risk of pregnancy and lactating patients;
  • Use of any products to promote hair growth within the 6 months prior to the Baseline Visit;
  • History of hair transplants;
  • Current skin disease;
  • History hypersensitivity to the active ingredients used in the study;
  • Participation in clinical trial in the year prior to this study;
  • Known history of non controled systemic disease (diabetes, hypertension, anemia, iron deficiency, and others);
  • Gastric diseases;
  • History of systemic disease (HIV, non specify autoimmune disease, hepatitis, and others).

研究组 & 干预措施

Neosil complete

Experimental

The patient will take the tablets, as follow:

3 tablets of Neosil, Oral, per day - during the initial 12 weeks; and

2 tablets of Neosil Oral, per day - during the last 12 weeks.

干预措施: Neosil complete (Drug)

Pantogar

Experimental

The patient wil take the tablets, as follow:

3 tablets of Placebo, Oral, per day - during the initial 12 weeks; and

3 tablets of Pantogar, Oral, per day - during the last 12 weeks.

干预措施: Pantogar (Drug)

Neosil

Experimental

The patient will take the tablets, as follow:

2 tablets of Neosil Oral, per day - during the 12 weeks.

干预措施: Neosil (Drug)

结局指标

主要结局

Hair density

时间窗: 24 weeks

次要结局

  • Incidence and severity of adverse events recorded during the study(24 weeks)

研究者

发起方
EMS
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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Efficacy and Safety of Neosil on Chronic Effluvium | 临床试验