Safety study of Herbified® shilajit resin
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20260438Keywords:
Shilajit, Preclinical study, Safety, Acute toxicity, Pharmacology, Clinical trial, Quality of lifeAbstract
Background: Shilajit is an ancient herbo-mineral compound with numerous proven health benefits. In recent times, Shilajit has been extensively studied in preclinical and clinical models to validate its documented effects. However, there are very few preclinical safety studies from India, and they are scattered.
Methods: In the present study, we evaluated the safety of Herbified® Shilajit resin in a subacute oral toxicity study in Wistar rats. The study was conducted for 28 days for the treatment and control groups. For the satellite control and satellite reversal group, the study was extended for an additional 14 days. In the current manuscript, we documented body weight, biochemical and hematological parameters, and histopathological analysis of vital organs in male and female groups.
Results: The study showed that treatment with low-, moderate-, and high-dose Herbified® Shilajit was safe, and outcomes across all parameters were comparable to those of the control group. Also, the outcomes in the satellite control and satellite reversal groups were similar to those in the control group.
Conclusions: Based on the results of this study, 206.65 mg/kg, p.o., of Shilajit in rats is safe, equivalent to approximately 2000 mg of Shilajit for an adult human (60 kg).
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References
Biswas TK, Pandit S, Mondal S, Biswas SK, Jana U, Ghosh T, et al. Clinical evaluation of spermatogenic activity of processed Shilajit in oligospermia. Andrologia. 2010;42(1):48-56. DOI: https://doi.org/10.1111/j.1439-0272.2009.00956.x
Cagno V, Donalisio M, Civra A, Cagliero C, Rubiolo P, Lembo D. In vitro evaluation of the antiviral properties of Shilajit and investigation of its mechanisms of action. J Ethnopharmacol. 2015;166:129-34. DOI: https://doi.org/10.1016/j.jep.2015.03.019
Das A, El Masry MS, Gnyawali SC, Ghatak S, Singh K, Stewart R, et al. Skin transcriptome of middle-aged women supplemented with natural herbo-mineral Shilajit shows induction of microvascular and extracellular matrix mechanisms. J Am Coll Nutr. 2019;38(6):526-36. DOI: https://doi.org/10.1080/07315724.2018.1564088
Gupta A, Kumar S, Singh P, Gupta P, Sastry J. Subacute oral toxicity assessment of a herbomineral formulation with Shilajit, Swarna Bhasma and other ingredients. J Drug Res Ayurvedic Sci. 2019;4(1):8-21. DOI: https://doi.org/10.5005/jdras-10059-0070
Iqubal A, Qadir A. Cardioprotective effect of Asphaltum punjabianum (Shilajit): An evidence-based review. Int J Herb Med. 2025;13(3):43-52. DOI: https://doi.org/10.22271/flora.2025.v13.i3a.987
Iqubal A, Qadir A. Clinical studies and safety evidence for human consumption of Shilajit: A herbo-mineral compound with multifaceted health benefits. Int J Basic Clin Pharmacol. 2025;14(4):630-40. DOI: https://doi.org/10.18203/2319-2003.ijbcp20251850
Keller JL, Housh TJ, Hill EC, Smith CM, Schmidt RJ, Johnson GO. The effects of Shilajit supplementation on fatigue-induced decreases in muscular strength and serum hydroxyproline levels. J Int Soc Sports Nutr. 2019;16(1):3. DOI: https://doi.org/10.1186/s12970-019-0270-2
Mansour EE, Abd Elhady EE, EL-Gawish AM. Prospective protective effect of Shilajit aqueous extract on nephrotoxicity induced by cypermethrin in albino rats. Egypt J Nutr Health. 2025;20(1):65-84. DOI: https://doi.org/10.21608/ejnh.2025.418673
Pandit S, Biswas S, Jana U, De RK, Mukhopadhyay SC, Biswas TK. Clinical evaluation of purified Shilajit on testosterone levels in healthy volunteers. Andrologia. 2016;48(5):570-575. DOI: https://doi.org/10.1111/and.12482
Pingali U, Nutalapati C. Shilajit extract reduces oxidative stress, inflammation, and bone loss to dose-dependently preserve bone mineral density in postmenopausal women with osteopenia: A randomized, double-blind, placebo-controlled trial. Phytomedicine. 2022;105:154334. DOI: https://doi.org/10.1016/j.phymed.2022.154334
Rajpoot A, Pandey AK, Roy VK, Mishra RK. Shilajit mitigates diabetes-induced testicular dysfunction in mice: A modulation in insulin sensitivity, germ cell-junctional dynamics, and oxido-apoptotic status. Andrologia. 2025;2025:5517176. DOI: https://doi.org/10.1155/and/5517176
Saheera S, Krishnamurthy P. Cardiovascular changes associated with hypertensive heart disease and aging. Cell Transplant. 2020;29:963689720920830. DOI: https://doi.org/10.1177/0963689720920830
Velmurugan C, Vivek B, Wilson E, Bharathi T, Sundaram T. Evaluation of safety profile of black shilajit after 91 days repeated administration in rats. Asian Pac J Trop Biomed. 2012;2(3):210. DOI: https://doi.org/10.1016/S2221-1691(12)60043-4
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