SheVari4®, a proprietary root extract from Asparagus racemosus, ameliorates menopausal health: insights from a randomized, double-blind, placebo controlled clinical trial

Raktim Chattopadhyay; Subhankar  Karmakar; Tandra R. Chakraborty; Manashi Bagchi; Samudra P. Banik; Debasis Bagchi

doi:10.29219/fnr.v70.14275

Raktim Chattopadhyay Esperer Onco Nutrition Pvt Ltd, Thane, Navi Mumbai, Maharashtra, India
Subhankar Karmakar Lakshya Hospital, Pune, Maharashtra, India
Tandra R. Chakraborty Biology Department, College of Arts and Sciences, Adelphi University, Garden City, NY, USA
Manashi Bagchi Research & Development Department, Dr. Herbs LLC, Concord, CA, USA
Samudra P. Banik Department of Microbiology, Government General Degree College, Narayangarh, Rathipur, West Bengal, India
Debasis Bagchi Biology Department, College of Arts and Sciences, Adelphi University, Garden City, NY, USA; and Department of Pharmaceutical Sciences, Texas Southern University College of Pharmacy, Houston, TX, USA

DOI: https://doi.org/10.29219/fnr.v70.14275

Keywords: Menopausal Quality of Life, Asparagus racemosus, Shatavarin IV, SheVari4®, Endocrine balance, Psychosocial wellbeing

Abstract

Objective: Menopause marks the natural end of reproductive phase of women caused by decline in levels of estrogen, progesterone and other reproductive hormones. Asparagus racemosus (Shatavari) is a medicinal herb particularly known to be effective in alleviating women’s reproductive health. Shatavarin IV, a steroidal saponin and a primary bioactive component in this herb, acts as a phytoestrogen by modulating the ER-alpha/ER-beta signalling, the TrkB-BDNF axis, and the Hypothalamic-Pituitary-Gonadal (HPG) and Hypothalamic-Pituitary-Adrenal (HPA) axes. In this study, the efficacy of SheVari4^® on alleviating the menopause-specific endocrine dysfunction and subsequent impaired quality of life (QOL) was assessed through a randomized double-blind placebo-controlled parallel arm trial conducted on 60 pre-, peri-, and post-menopausal women.

Methodology: Sixty women (age 50.0 ± 7.4 years) randomized in two equal groups were administered with 100 mg SheVari4^® or placebo capsules once daily for 8 weeks. Assessment of Menopause-Specific Quality of Life (MENQOL) along with domain scores across vasomotor, psychosocial, physical, and sexual function constituted primary endpoint analysis; changes in serum estradiol E2, Follicle Stimulating Hormone (FSH), progesterone, cortisol, Anti Mullerian Hormone (AMH), Sex Hormone-Binding Globulin (SHBG) and free testosterone were assessed as secondary endpoint analysis. Safety of the formulation was evaluated in terms of body mass index, blood biochemistry and liver function test.

Results: SheVari4 induced a 42.8% reduction in MENQOL versus placebo. Significant improvements in functioning (vs. placebo) were observed, respectively, across vasomotor (53.1% vs. 14.5%), psychosocial (53.6% vs. 9.9%), physical (39.2% vs. 6.5%) and sexual (29.4% vs. 10.7%) domains. The formulation also increased E2 (+36.44% vs. –2.08%) and progesterone (+0.30% vs. –2.88%) coupled with marked reduction in levels of FSH (–38.18% vs. +12.97%) and cortisol (–26.87% vs. +17.16%). Concomitantly, AMH, SHBG, and free testosterone were also favorably modulated. Blood biochemistry, liver function tests, and vital signs confirmed the broad-spectrum safety of SheVari4^®.

Conclusion: SheVari4^® significantly improved menopause-specific QOL and endocrine parameters in peri- and post-menopausal women, with a well-established safety profile.

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Author Biography

Debasis Bagchi, Biology Department, College of Arts and Sciences, Adelphi University, Garden City, NY, USA; and Department of Pharmaceutical Sciences, Texas Southern University College of Pharmacy, Houston, TX, USA

Debasis Bagchi, PhD, MACN, FRSM, CNS, FISNFF, CFFS, MAIChE, received his Ph.D. in Medicinal Chemistry in 1982. He is an Adjunct Professor in the College of Pharmacy & Health Sciences, Texas Southern University, Houston, TX; an Adjunct Faculty in the Department of Biology, Adelphi University, Garden City, NY, and the Course Director of Neurotoxicology (BIO 585); an Adjunct Faculty in the Department of Psychology, Gordon F. Derner School of Psychology, Adelphi University, Garden City, NY, and the Course Co-Director of Integrative Neuroscience Seminar (PIA395-001); and Chief Scientific Affairs, Cepham Research Center, Somerset, NJ. Ex-Professor in the Department of Pharmacological and Pharmaceutical Sciences at the University of Houston College of Pharmacy, Houston, TX. He served as the Chief Scientific Officer at Cepham Inc, Belmont, NJ, from June 2013, till Dec 2018, and as the Director of Scientific Affairs, VNI Inc., Bonita Springs, FL, from Jan 2019 to Jan 2023. He served as the Senior Vice President of Research & Development of InterHealth Nutraceuticals Inc, Benicia, CA, from 1998 till Feb 2011; Director of Innovation and Clinical Affairs, of Iovate Health Sciences, Oakville, ON, till June 2013.

Dr. Bagchi received the Master of American College of Nutrition Award in October 2010; became a Fellow of ISNFF in 2021 and awarded an overseas Fellow of Royal Society of Medicine in 2022. He is the Past Chairman of International Society of Nutraceuticals and Functional Foods (ISNFF), Past President of American College of Nutrition, Clearwater, FL, and Past Chair of the Nutraceuticals and Functional Foods Division of Institute of Food Technologists (IFT), Chicago, IL. He is serving as a Distinguished Advisor on the Japanese Institute for Health Food Standards (JIHFS), Tokyo, Japan. Dr. Bagchi is a Member of the Study Section and Peer Review Committee of the National Institutes of Health (NIH), Bethesda, MD. Dr. Bagchi has 437 papers in peer reviewed journals, 46 books and 20 patents. Dr. Bagchi is also a Member of the Society of Toxicology, Member of the New York Academy of Sciences, Fellow of the Nutrition Research Academy, and Member of the TCE stakeholder Committee of the Wright Patterson Air Force Base, OH. Dr. Bagchi is the Associate Editors of the Journal of Functional Foods, Journal of the American College of Nutrition, and Archives of Medical and Biomedical Research, and also serving as Editorial Board Member of numerous peer reviewed journals, including Antioxidants & Redox Signaling, Cancer Letters, Food & Nutrition Research, Toxicology Mechanisms and Methods, The Original Internist, and other peer reviewed journals.