An open label, phase IV, randomized clinical trial of ArnikaPlus Combo Pack on hair problems
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess the efficacy of test products in diffuse hair fall and growth of new hair and hair quality improvement
研究概览
简要总结
This study is an open label, phase 4, single centre trial to monitor the toxicity, risks, utility, benefits and optimal use after the efficacy of ArnikaPlus Combo Pack, containing (ArnikaPlus Aqua Base Hair Root Vitalizer, ArnikaPlus-S Anti-dandruff Hair & Scalp Cleanser and ArnikaPlus Oil Hair Root Nourisher) for 12 weeks in 100 patients to diffuse hair loss/ slow growth of hair that will be conducted in India. For selection of subjects Patch test and following biochemical tests will be assessed: Complete Blood Count (TC, DC, ESR, Hb, PCV, MCV, MCH, MCHC), Blood glucose (F), Dihydrotestosterone (Male), TSH, Total protein, Serum Iron, Oestrogen (Female) and USG lower abdomen (to exclude PCOD). Subjects will follow up at 4 weeks, 8 weeks, and at 12-week treatment endpoint. Clinical efficacy will be assessed by Global photographs (vertex, mid-pattern, frontal, and temporal views), Hair distribution and growth test (7 Point VAS), Hair pull test (right, left, parietal, frontal and occipital areas), Comb test and Assessment of dandruff. Data will be statistically analyzed by examining the improvement score at treatment endpoint in a multivariable linear regression analysis with group and baseline score as the independent variables. Alpha for statistical significance will be set at p less than 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female participants in the age group of 18-40 years.
- •2.Participants willing to give informed consent.
- •3.Participants willing to comply with the study procedures.
- •4.Participants who are fit and no need any hospital administration.
- •5.Complaints for diffuse hair loss/ slow growth of hair.
- •6.Complaints for dandruff and lice.
- •7.Complaints for bad quality of hair (elasticity, strength, fragility, longevity, smoothness).
- •8.Complaints for fungal infection.
排除标准
- •1.History of systemic or cutaneous malignancy or lesions.
- •2.History of psoriasis, polycystic ovarian syndrome.
- •3.Advanced or poorly controlled thyroidisms, diabetes and anemia.
- •4.Unstable cardiovascular disease.
- •5.Clinically significant medical or psychiatric disease.
- •6.Evidence of immunocompromised state.
- •7.Serious local infection (e.g. cellulites, abscess) or systemic infection (e.g. pneumonia, septicemia) within six months prior to enrollment.
- •8.Pregnant and lactating women.
结局指标
主要结局
To assess the efficacy of test products in diffuse hair fall and growth of new hair and hair quality improvement
时间窗: 8 months
次要结局
- To assess the efficacy of test products in diffuse hair fall and growth of new hair and hair quality improvement(3 months)