A prospective, randomized double-blind, placebo-controlled study for safety and efficacy of SesZen-BioTM: a proprietary Sesbania grandiflora extract in managing hair and scalp health in healthy adults

Ratna Upadhyay, Mihir C. Gadani, Sneha Badak, Nayan Patel, Apeksha Merja, Maheshvari Patel
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Abstract

Background: Hair loss, a common multifactorial condition affecting both genders, results from causes like extrinsic factors (pollution, sun, humidity, and temperature), nutritional variation, or intrinsic factors such as ageing, heredity, hormonal and medical conditions. Some of the damages caused by these factors can be effectively managed with multivitamins, minerals, antioxidant natural products. Present study assessed use of standardised herbal Sesbania grandiflora extract for improving hair density, hair thickness and scalp health along with a serum biomarker to establish the probable mechanism of action. Methods: The study was approved by the ethics committee and was conducted as per standard national regulations. 51 randomized subjects (mean age: 39.40±5.80 years) received either test-treatment or placebo for consecutive 56 days. Instrumental assessments included a phototrichogram to assess hair density, thickness, and scalp condition. Results: SesZen-BioTM which is derived from Sesbania grandiflora extracts showed an improvement in hair density, hair thickness and ferritin in 8 weeks of usage suggesting it stimulates the keratin production which resulted in improved follicle growth. By day 56 of usage, hair density and thickness improved by 58.92±28.69 cm2 and 3.68±2.69 μm respectively from baseline (both p<0.0001) in the treatment group. This indicates towards 25% improvement in hair density, 16.94% in hair thickness and almost 72% volunteers indicated an improvement in hair health along with 27% increase in serum ferritin. Conclusions: Sesbania grandiflora extract -SesZen-Bio® showed beneficial nutritional effects on research subjects, proving its usefulness as a well-tolerated and efficient daily supplement to improve hair health.
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一项前瞻性、随机双盲、安慰剂对照研究,以了解 SesZen-BioTM(一种专有的大叶芝麻提取物)对健康成年人头发和头皮健康管理的安全性和有效性
背景:脱发是一种影响男女两性的常见多因素疾病,其原因包括外在因素(污染、阳光、湿度和温度)、营养变化或内在因素(老化、遗传、荷尔蒙和医疗状况)。这些因素造成的一些损害可以通过多种维生素、矿物质和抗氧化天然产品得到有效控制。本研究评估了标准化草本大叶黄杨提取物在改善头发密度、头发厚度和头皮健康方面的作用,并通过血清生物标记物来确定可能的作用机制:该研究已获得伦理委员会的批准,并按照标准的国家法规进行。51 名随机受试者(平均年龄:39.40±5.80 岁)连续 56 天接受试验治疗或安慰剂治疗。仪器评估包括光密度图,以评估头发密度、厚度和头皮状况:SesZen-BioTM是从大叶芝麻提取物中提炼出来的,使用 8 周后,头发密度、头发厚度和铁蛋白均有所改善,这表明它能刺激角蛋白生成,从而改善毛囊生长。使用第 56 天时,治疗组的头发密度和厚度分别比基线提高了 58.92±28.69 cm2 和 3.68±2.69 μm(均 p<0.0001)。这表明头发密度提高了 25%,头发厚度增加了 16.94%,近 72% 的志愿者表示头发健康状况有所改善,血清铁蛋白增加了 27%:Sesbania grandiflora extract -SesZen-Bio® 对研究对象产生了有益的营养影响,证明了其作为一种耐受性良好且有效的日常补充剂,在改善头发健康方面的作用。
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