Efficacy and safety study of Ayurvedic hair oil formulations in healthy volunteers with self perceived hair thinning and hair loss.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Evaluate changes in hair density
研究概览
简要总结
The present work is undertaken to assess the efficacy and safety of hair oil formulations in healthy volunteers with self-perceived hair thinning and hair loss. It was a twelve-week study with four weeks of follow-up. The study population was 120 healthy volunteers randomly divided into four equal groups of 30 individuals. Group HO - 1, Group HO - 2, Group HO - 3 was the interventional group, and Group HO - 0 was the comparator group. Hair oil formulations were topically administered. The primary outcome of the study was to analyze changes in hair density from Baseline to Week 12 and week 16 and the secondary outcomes was to analyze changes in the number of hair loss in comb test and pull test, subjective assessment of hair health variables through Modified Self-assessment questionnaire, effect on dandruff through Adherent Scalp Flaking Score (ASFS), acceptability of hair oil formulation though modified topical product usability questionnaire and collecting information regarding self observed and reported Adverse events (AEs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Willing to provide voluntary written informed consent 2.Patients having selfreported thinning or hair loss for more than 6 months prior to screening 3.Patient clinically confirmed to have hair loss or thinning though physical exam for female pattern hair loss Savin Classification score of I 2 TO II 1for male pattern hair loss NorwoodHamilton classification score I AND II AND III 3.Patient willing to maintain same hair style hair color and hair regimen throughout the study and use mild non medicated shampoo during the study period 4.Women of child bearing age willing to adopt medically sound method of birth control during the trial period.
排除标准
- •Clinical diagnosis of alopecia areata or scarring forms of alopecia or hair loss due to disease injury or medical therapy
- •Patient hypersensitive to study product or hair dye and its component.
- •History of hair transplant.
- •4.Patients with diagnosed organic disease of scalp with dermatological origin (other than mild to moderate dandruff determined by Adherent Scalp Flaking Score) like psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis which requires medication.
- •5.Pregnant or lactating women 6.Diagnosis of organic diseases including Uncontrolled diabetes mellitus (DM), endocrinal disorder, Hypertension, neoplastic, severe cardiovascular diseases, renal insufficiency, psychiatric disorders, iron deficiency, coagulopathies etc or on any medication that can cause potential hair loss or affects hair growth.
结局指标
主要结局
Evaluate changes in hair density
时间窗: Time Frame Baseline to Week 12and week 16
次要结局
- To analyze changes in the number of hair loss in comb test and pull test, subjective assessment of hair health variables through Modified Self-assessment questionnaire, effect on dandruff through Adherent Scalp Flaking Score (ASFS), acceptability of hair oil formulation though modified topical product usability questionnaire, Safety will be assessed at all visits through vital signs and scalp evaluations for symptoms of irritation and self observed and reported Adverse events (AEs).(Time Frame Baseline to Week 12and week 16)