WORLD JOURNAL OF ADVANCE
HEALTHCARE RESEARCH

Dr. Aarati Patil, Prof. Sadhana Sathaye, Ms. Gayatri Sawale, Dr. Kshitija Berde, *Dr. Aishwarya Deshpande

ABSTRACT

Background: Gynoveda® JEEHV Ayurvedic Tablets are a polyherbal formulation developed to support women’s reproductive health and enhance natural fertility. Given the potential for prolonged use in clinical settings, a systematic evaluation of its safety profile is essential. Objective: To assess the sub-acute oral toxicity of Gynoveda® JEEHV Ayurvedic Tablets following repeated administration over 28 days in Wistar rats, in accordance with OECD Test Guideline 407. Methods: A total of 40 Wistar rats (20 males and 20 females) were randomized into four groups: control, low dose (200 mg/kg/day), medium dose (400 mg/kg/day), and high dose (1000 mg/kg/day). The doses were derived using allometric scaling from the human therapeutic dose. The formulation was administered orally once daily for 28 consecutive days. Clinical observations, body weight, food and water intake were monitored throughout the study. At study termination, haematological and serum biochemical parameters were evaluated, followed by necropsy and histopathological examination of major organs. A satellite group from the high-dose cohort was observed for an additional 14-day recovery period. Results: No mortality or treatment-related clinical signs of toxicity were observed in any group. All animals exhibited normal growth patterns with no significant changes in food or water intake. Haematological parameters remained within physiological limits, although a dose-dependent increase in platelet counts was noted. Serum biochemical analysis revealed no significant alterations in liver and kidney function markers across all groups. Elevated triglyceride levels were observed, particularly in female rats; however, these changes were reversible, as evidenced by normalization in the satellite group. Histopathological evaluation of vital organs showed no treatment-related abnormalities. Conclusion: Repeated oral administration of Gynoveda® JEEHV Ayurvedic Tablets for 28 days did not produce any significant toxicological effects in Wistar rats, even at doses up to five times the human therapeutic equivalent. The formulation can be considered safe under the conditions of this study, supporting its potential for long-term use.

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