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Dose-Dependent Efficacy of a Combined Standardized Extract of Fenugreek and Shatavari on Menopausal Symptoms: A
Roopa Nanjangud Kashinath1, Vidya Vishwanath Bhat2, Abhijeet Morde3
1BGS Global Institute of Medical Sciences, Bengaluru, India.
Objective:
To evaluate the efficacy of Fenavari, a novel formulation of standardized Asparagus racemosus and Trigonella foenum-graecum, in alleviating menopausal symptoms in women.
Methods:
This multicenter, randomized, double-blind, placebo-controlled, three-arm, parallel-group study enrolled women aged 40-60 years with menopausal symptoms. A total of 150 participants were randomized (1:1:1) to receive Fenavari 300 mg, Fenavari 500 mg, or placebo once daily for 84 days. Menopausal symptoms were assessed using the Menopause Rating Scale (MRS), sleep using the Pittsburgh Sleep Quality Index, mood using the Profile of Mood States, and anxiety using the Beck Anxiety Inventory at baseline and Days 14, 28, 56, and 84. Hormonal parameters (serum estradiol, progesterone, and follicle-stimulating hormone [FSH]) were measured at baseline and on Days 56 and 84. Safety and laboratory assessments were conducted throughout the study.
Results:
A total of 138 participants completed the study. Both Fenavari 300 mg and 500 mg significantly reduced MRS total scores from Day 14 through Day 84 compared with placebo (Fenavari 300 mg: -8.26 ± 0.46, p < 0.0001; Fenavari 500 mg: -10.40 ± 0.40, p < 0.0001; placebo: -4.09 ± 0.47). Somatic and psychological symptoms improved significantly by Day 84 in both treatment groups, with earlier and greater effects observed in the 500 mg group. Urogenital symptoms showed significant improvement by Day 84 in both groups. Both doses of Fenavari significantly reduced hot flashes and night sweats by Day 84. Significant improvements were also observed in anxiety, sleep quality, and mood by Day 84. Serum estradiol increased significantly with corresponding reductions in FSH by Day 84 compared with placebo. Both doses were well-tolerated with no safety concerns reported.
Conclusion:
Fenavari significantly improved menopausal symptoms across somatic, psychological, and vasomotor domains from Day 14 onward, and improved sleep, anxiety, and mood along with favorable hormonal changes and good tolerability, supporting its potential as a safe nonhormonal option for menopause management.