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罗斯马甘™作为促进头发生长和头皮健康的天然疗法:一项双盲、随机、三臂、安慰剂对照临床试验。

Rosmagain™ as a Natural Therapeutic for Hair Regrowth and Scalp Health: A Double-Blind, Randomized, Three-Armed, Placebo-Controlled Clinical Trial.

作者信息

Patel Maheshvari N, Tuli Natasha, Patel Nayan, Merja Apeksha

机构信息

Clinical Research, NovoBliss Research, Ahmedabad, IND.

Pharmacology, Swaminarayan University, Ahmedabad, IND.

出版信息

Cureus. 2025 Jun 13;17(6):e85906. doi: 10.7759/cureus.85906. eCollection 2025 Jun.

DOI:10.7759/cureus.85906
PMID:40656290
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12256010/
Abstract

Introduction Alopecia is a common condition marked by progressive hair loss, influenced by aging, genetics, hormones, and environmental factors. It affects individuals of all ages, often impacting self-esteem and quality of life. Rosemary and lavender oils have gained attention for their antioxidant, anti-inflammatory, and antimicrobial properties, promoting scalp health, follicular stimulation, and hair regrowth. While rosemary oil enhances circulation and extends the anagen phase, lavender oil soothes the scalp and supports hair growth. This study evaluates the efficacy and safety of rosemary-lavender oil and rosemary-castor oil in comparison of coconut oil in promoting hair growth and scalp health. Method This prospective, double-blind, randomized, three-arm, placebo-controlled clinical trial evaluated the efficacy and safety of rosemary-lavender oil and rosemary-castor oil, in comparison with coconut oil for hair growth over 90 days. This study was conducted per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP), Declaration of Helsinki (2013), and Indian Council of Medical Research (ICMR) guidelines, the study received ethical approval (ACEAS IEC, February 10, 2024) and was registered with Clinical Trials Registry - India (CTRI; CTRI/2024/07/071115). Ninety healthy participants (18-55 years) were randomized equally. Study assessed the hair growth rate, thickness, density, length, scalp condition, and anagen:telogen (A:T) ratio using a phototrichogram (CASLite Nova, Catseye Systems & Solutions Pvt Ltd, Navi Mumbai, India). Visual/tactile assessments were done by a certified dermatologist. Statistical analysis used SPSS v29.0.1.0 (IBM Inc., Armonk, New York) and Excel 2019 (Microsoft, Redmond, Washington), applying paired t-tests (p< 0.05). Result The study demonstrated that rosemary-lavender oil and rosemary-castor oil significantly improved hair growth rate, thickness, density, length, and reduced hair fall compared to coconut oil (p<0.0001). Hair growth rate increased 0.22 ± 0.04 mm/day to 0.34 ± 0.05 mm/day or 57.73% (p<0.0001) change from baseline (CFB) in rosemary-lavender oil and 0.23 ± 0.04 mm/day to 0.33 ± 0.05 mm/day or 47.59% CFB (p<0.0001) in rosemary-castor oil. Hair thickness improved by 68.70% and 66.07% (p<0.0001), while hair density increased by 32.21% and 32.15%, respectively (p< 0.0001). Hair length showed a 28.78% and 37.67% increase, while hair fall reduction exceeded 40% in both rosemary groups (p<0.0001).  Conclusion The findings demonstrate that rosemary-lavender, Rosmagain™, and rosemary-castor oils significantly provide beneficial effects in hair growth parameters. Their ability to enhance hair thickness, density, length, and reduced hair fall suggests they may serve as effective natural therapeutic alternatives for hair regrowth. With a favourable safety profile, these formulations offer a promising plant-based solution for good hair and scalp health. This formulation is designed to restore balance to the hair growth cycle, creating an optimal scalp environment for sustained and healthy hair growth.

摘要

引言

脱发是一种常见病症,其特征为渐进性脱发,受衰老、遗传、激素和环境因素影响。它影响各个年龄段的人,常常对自尊和生活质量产生影响。迷迭香油和薰衣草油因其抗氧化、抗炎和抗菌特性而受到关注,有助于促进头皮健康、刺激毛囊和促进头发生长。迷迭香油可增强血液循环并延长生长期,而薰衣草油则可舒缓头皮并支持头发生长。本研究评估了迷迭香 - 薰衣草油和迷迭香 - 蓖麻油与椰子油相比在促进头发生长和头皮健康方面的功效和安全性。

方法

这项前瞻性、双盲、随机、三臂、安慰剂对照临床试验评估了迷迭香 - 薰衣草油和迷迭香 - 蓖麻油与椰子油相比在90天内对头发生长的功效和安全性。本研究按照国际人用药品注册技术协调会(ICH)的《药物临床试验质量管理规范》(GCP)、《赫尔辛基宣言》(2013年)以及印度医学研究理事会(ICMR)的指南进行,该研究获得了伦理批准(ACEAS IEC,2024年2月10日),并在印度临床试验注册中心(CTRI;CTRI/2024/07/071115)进行了注册。90名健康参与者(18 - 55岁)被平均随机分组。研究使用毛发照像仪(CASLite Nova,Catseye Systems & Solutions Pvt Ltd,印度新孟买)评估头发生长速率、厚度、密度、长度、头皮状况以及生长期与休止期(A:T)比率。由一名认证皮肤科医生进行视觉/触觉评估。统计分析使用SPSS v29.0.1.0(IBM公司,纽约州阿蒙克)和Excel 2019(微软公司,华盛顿州雷德蒙德),采用配对t检验(p < 0.05)。

结果

研究表明,与椰子油相比,迷迭香 - 薰衣草油和迷迭香 - 蓖麻油显著提高了头发生长速率、厚度、密度、长度,并减少了脱发(p < 0.0001)。迷迭香 - 薰衣草油组的头发生长速率从基线(CFB)的0.22 ± 0.04毫米/天增加到0.34 ± 0.05毫米/天,变化率为57.73%(p < 0.0001);迷迭香 - 蓖麻油组从0.23 ± 0.04毫米/天增加到0.33 ± 0.05毫米/天,变化率为47.59%(p < 0.0001)。头发厚度分别改善了68.70%和66.07%(p < 0.0001),而头发密度分别增加了32.21%和32.15%(p < 0.0001)。头发长度分别增加了28.78%和37.67%,两个迷迭香组的脱发减少均超过40%(p < 0.0001)。

结论

研究结果表明,迷迭香 - 薰衣草油(Rosmagain™)和迷迭香 - 蓖麻油在头发生长参数方面具有显著的有益效果。它们增强头发厚度、密度、长度以及减少脱发的能力表明,它们可能成为促进头发生长的有效天然治疗替代品。由于具有良好的安全性,这些配方为头发和头皮健康提供了一种有前景的植物性解决方案。该配方旨在恢复头发生长周期的平衡,为持续健康的头发生长创造最佳的头皮环境。

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An Overview of Commonly Used Natural Alternatives for the Treatment of Androgenetic Alopecia, with Special Emphasis on Rosemary Oil.雄激素性脱发常用天然替代疗法概述,重点介绍迷迭香油
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