CTRI/2023/07/055432已完成2/3 期
Clinical Study to evaluate the Herbal formulation for its action in promoting Healthy hair growth and minimizing Hair losses
Plantayu life science LLP1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月30日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluate changes in Target Area Hair Count (TAHC) measured by Dermobella hair analyzer.
研究概览
简要总结
The present work is undertaken to assess the action of herbal formulations in promoting hair growth and minimizing hair losses.The study population was 60 healthy volunteers randomly divided in two equal groups of 30 individuals each.
Group A:- Subjects were advised to apply 5-10ml solution on Scalp/area once a day.
Group B:- Subjects were advised to apply Standard formulation as per prescribed dosage once a day.
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.Age from
- •60 yrs 2.Male or female 3.Willing to provide voluntary written informed consent. 4.Patients having self-reported thinning or hair loss for more than 6 months prior to screening 5.Patient clinically confirmed to have hair loss or thinning though physical exam ( for female pattern hair loss Savin Classification score of I 2-II 1,[4] for male pattern hair loss Norwood-Hamilton classification score I, II, III) [5] 6.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. 7.Women of child bearing age willing to adopt medically sound method of birth control during the trial period.
排除标准
- •1.Clinical diagnosis of alopecia areata or scarring forms of alopecia or hair loss due to disease, injury or medical therapy 2.Patient hypersensitive to study product or hair dye and its component.
- •3.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.
- •7.Refusal to provide informed consent.
结局指标
主要结局
Evaluate changes in Target Area Hair Count (TAHC) measured by Dermobella hair analyzer.
时间窗: base line to 60 days
次要结局
- To analyze changes in number of hair loss in comb test & pull test, subjective assessment of hair health variables though 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).(base line to 12 weeks)
研究者
研究点 (1)
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