{"title":"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","authors":"Ratna Upadhyay, Mihir C. Gadani, Sneha Badak, Nayan Patel, Apeksha Merja, Maheshvari Patel","doi":"10.18203/2349-3259.ijct20240929","DOIUrl":null,"url":null,"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.\nMethods: 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.\nResults: 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.\nConclusions: 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.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"12 11","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"Ratna Upadhyay, Mihir C. Gadani, Sneha Badak, Nayan Patel, Apeksha Merja, Maheshvari Patel\",\"doi\":\"10.18203/2349-3259.ijct20240929\",\"DOIUrl\":null,\"url\":null,\"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.\\nMethods: 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.\\nResults: 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.\\nConclusions: 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.\",\"PeriodicalId\":13787,\"journal\":{\"name\":\"International Journal of Clinical Trials\",\"volume\":\"12 11\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-04-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Clinical Trials\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.18203/2349-3259.ijct20240929\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Clinical Trials","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.18203/2349-3259.ijct20240929","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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
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.