A prospective, randomized double-blind, placebo-controlled study for safety and efficacy of SesZen-Bio™: a proprietary Sesbania grandiflora extract in managing hair and scalp health in healthy adults
DOI:
https://doi.org/10.18203/2349-3259.ijct20240929Keywords:
Biotin, Sesbania grandiflora, Hair loss, Hair thinning, AlopeciaAbstract
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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References
Nestor MS, Ablon G, Gade A, Han H, Fischer DL. Treatment options for androgenetic alopecia: Efficacy, side effects, compliance, financial considerations, and ethics. J Cosmet Dermatol. 2021;20(12):3759-81.
Ludwig E. Classification of the types of androgenetic alopecia (common baldness) occuring in the female sex. Br J Dermatol. 1977;97:247–54.
Levy LL, Emer JJ. Female pattern alopecia: current perspectives. Int J Womens Health. 2013;5:541–56.
Phillips TG, Slomiany WP, Allison R. Hair loss: common causes and treatment. Am Fam Physician. 2017;96(6):371-8.
Fabbrocini G, Cantelli M, Masarà A, Annunziata MC, Marasca C, Cacciapuoti S. Female pattern hair loss: A clinical, pathophysiologic, and therapeutic review. Int J Womens Dermatol. 2018;4(4):203-11.
Olsen EA. Female pattern hair loss. J Am Acad Dermatol. 2001;45:S70–80.
Singal A, Sonthalia S, Verma P. Female pattern hair loss. Indian J Dermatol Venereol Leprol. 2013;79:626-40.
Guo EL, Katta R. Diet and hair loss: effects of nutrient deficiency and supplement use. Dermatol Pract Concept. 2017;7(1):1-10.
Birch MP, Lalla SC, Messenger AG. Female pattern hair loss. Clin Exp Dermatol. 2002;27:383–8.
Park S, Lee J. Modulation of hair growth promoting effect by natural products. Pharmaceutics. 2021;13(12):2163.
World Health Organization. Preventing and controlling micronutrient deficiencies in populations affected by an emergency. Availability at: https://www.who.int/publications/m/item/WHO-WFP-UNICEF-statement-micronutrients-deficiencies-emergency#:~:text=More%20than% 202%20billion%20people,in%20more%20than%20one%20micronutrient. Accessed 02 December 2023.
Almohanna HM, Ahmed AA, Tsatalis JP, Tosti A. The role of vitamins and minerals in hair loss: A Review. Dermatol Ther (Heidelb). 2019;9(1):51-70.
Dattola A, Silvestri M, Bennardo L, Passante M, Scali E, Patruno C, et al. Role of vitamins in skin health: A systematic review. Curr Nutr Rep. 2020;9:226-35.
Williamson D, Gonzalez M, Finlay AY. The effect of hair loss on quality of life. J Eur Acad Dermatol Venereol. 2001;15(2):137-9.
Reid EE, Haley AC, Borovicka JH. Clinical severity does not reliably predict quality of life in women with alopecia areata, telogen effluvium, or androgenic alopecia. J Am Acad Dermatol. 2012;66(3):e97-e102.
Govindan S, Shanmugasundaram ER. Evaluation of the nutritive value of agathi (Sesbania grandiflora) leaf protein concentrates. Indian J Nutr Diet. 1987;24(12):370–5.
Yadav P, Harisha CR, Prajapati PK. Pharmacognostical and physicochemical evaluation of Agasti leaf. Int J Ayurveda Res. 2010;1(4):231-6.
Arthanari S, Periyasamy P. Phenolic composition, antioxidant and anti-fibrotic effects of Sesbania grandiflora L. (Agastya) - An edible medicinal plant. Ayu. 2020;41(4):242-9.
Gadani M, Upadhyay R, Raut S, Pandey K. Characterization of plant-based biotin from SesZenBioTM and in silico studies to prove its potential in hair care. Int J Biochem Res. 2022;31(3):32-8.
Soleymani T, Shapiro J. The infatuation with biotin supplementation: is there truth behind its rising popularity? a comparative analysis of clinical efficacy versus social popularity. J Drugs Dermatol. 2017;16(5):496-500.
Patel DP, Swink SM, Castelo-Soccio L. A Review of the Use of Biotin for Hair Loss. Skin Appendage Disord. 2017;3(3):166-9.
Kim SO, Han Y, Ahn S. Kojyl cinnamate esters are peroxisome proliferator-activated receptor α/γ dual agonists. Bioorg Med Chem. 2018;26(21):5654-63.
Dickinson A, Shao A, Boyon N, Franco JC. Use of dietary supplements by cardiologists, dermatologists and orthopedists: report of a survey. Nutr J. 2011;10:20.
Gokce N, Basgoz N, Kenanoglu S. An overview of the genetic aspects of hair loss and its connection with nutrition. J Prev Med Hyg. 2022;63(2 Suppl 3):E228-E238.
Sebetić K, Sjerobabski Masnec I, Cavka V, Biljan D, Krolo I. UV damage of the hair. Coll Antropol. 2008;32(Suppl 2):163-5.
Beoy LA, Woei WJ, Hay YK. Effects of tocotrienol supplementation on hair growth in human volunteers. Trop Life Sci Res. 2010;21(2):91-9.
Zempleni J, Hassan YI, Wijeratne SS. Biotin and biotinidase deficiency. Expert Rev Endocrinol Metab. 2008;3(6):715-24.
Trüeb RM. Serum Biotin Levels in Women Complaining of Hair Loss. Int J Trichology. 2016;8(2):73-7.
Limat A, Suormala T, Hunziker T. Proliferation and differentiation of cultured human follicular keratinocytes are not influenced by biotin. Arch Dermatol Res. 1996;288:31–8.
Merja A, Nayan P, Maheshvari P. Safety and efficacy of Arcedin™ infused anti-gray hair serum in adult human subjects with partially gray hair. J Dermat Cosmetol. 2023;7(4):115-23.
Hochman LG, Scher RK, Meyerson MS. Brittle nails: response to daily biotin supplementation. Cutis. 1993;51(4):303-5.
Cashman MW, Sloan SB. Nutrition and nail disease. Clin Dermatol. 2010;28:420–5.
Natarelli N, Gahoonia N, Sivamani RK. Integrative and mechanistic approach to the hair growth cycle and hair loss. J Clin Med. 2023;12(3):893.
Ablon G. A 3-month, randomized, double-blind, placebo-controlled study evaluating the ability of an extra-strength marine protein supplement to promote hair growth and decrease shedding in women with self-perceived thinning hair. Dermatol Res Pract. 2015;2015:841570.
Park SY, Na SY, Kim JH, Cho S, Lee JH. Iron plays a certain role in patterned hair loss. J Korean Med Sci. 2013;28(6):934-8.
Aslam MF, Khalid M, Amad Aslam M. The association of serum ferritin levels with non-scarring alopecia in women. Cureus. 2022;14(12):e32123.
Treister-Goltzman Y, Yarza S, Peleg R. Iron deficiency and nonscarring alopecia in women: Systematic review and meta-analysis. Skin Appendage Disord. 2022;8(2):83-92.
Friedman ES, Friedman PM, Cohen DE, Washenik K. Allergic contact dermatitis to topical minoxidil solution: etiology and treatment. J Am Acad Dermatol. 2002;46(2):309-12.
Jacobs D, Buttigieg CF. Minoxidil experience in Australia. Med J Aust. 1981;1(9):477-8.
Ramírez-Marín HA, Tosti A. Role of Oral Minoxidil in Patterned Hair Loss. Indian Dermatol Online J. 2022;13(6):729-33.
Merja A, Patel N, Patel M, Patnaik S, Ahmed A, Maulekhi S. Safety and efficacy of RegendilTM infused hair growth promoting product in human subject having hair fall complaints (alopecia). J Cosmet Dermatol. 2024;23(3):938-48.
Stephens TJ, Berkowitz S, Marshall T, Kogan S, Raymond I. A prospective six-month single-blind study evaluating changes in hair growth and quality using a nutraceutical supplement in men and women of diverse ethnicities. J Clin Aesthet Dermatol. 2022;15(1):21-6.
Gadani M, Badak S, Upadhyay R. Development of micronutrient standardized bio-potentiated Sesbania Grandiflora extract- SesZen-BioTM - a Potential Candidate for Hair Growth. (Under review, J Appl Pharm Res, 2024).
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