Effects of Shatavari (Asparagus racemosus) Root Extract on Sexual Wellness in Women: Findings from a Prospective, Randomized, Double-Blind, Three-Arm, Parallel-Group, Placebo-Controlled Study

John Ademola,1 Supriya Mahajan,2 Mayakalyani Srivathsan,3 Deepak Langade3 1Department of Clinical Research, San Francisco Research Institute, San Francisco, CA, 94127, USA; 2Department of Gynecology and Obstetrics, Tieten Medi City Hospital, Thane, Maharashtra, 400610, India; 3Department of Pharmacology, D Y Patil University of School and Medicine, Navi Mumbai, Maharashtra, 400706, IndiaCorrespondence: Mayakalyani Srivathsan, Department of Pharmacology, D Y Patil University of School and Medicine, Nerul, Navi Mumbai, Maharashtra, 400706, India, Tel +919820182621, Email [email protected]: Women’s sexual health is affected by physical, psychological, and emotional aspects. In Ayurvedic medicine, Shatavari (Asparagus racemosus) is traditionally classified as a Rasayana known to promote reproductive health and overall well-being in women. The present study aims to evaluate the safety and efficacy of a standardized Shatavari root extract (SHT) in improving women’s sexual health.Patients and Methods: A prospective, randomized, double-blinded, placebo-controlled, three-armed study was conducted over 8 weeks with 135 women participants. Participants were randomly assigned to receive either SHT, Shatavari with Ashwagandha root extracts (SHT-ARE), or a placebo (PL). The primary outcome was assessed using the Female Sexual Function Index (FSFI). Secondary outcomes were measured by Satisfying Sexual Events (SSEs), Female Sexual Distress Scale (FSDS), Profile of Mood States (POMS), Oxford Happiness Questionnaire (OHQ), and Pittsburgh Sleep Quality Index (PSQI), which were used for efficacy analysis. The safety parameters were monitored by treatment-emergent adverse events and changes in liver, thyroid, and renal function markers.Results: At post-intervention (8 weeks), the SHT-ARE group demonstrated improvements in FSFI Arousal (P = 0.041), Lubrication (P = 0.027), Orgasm (P = 0.031), and Total FSFI (P = 0.005) scores compared to the PL group, whereas the SHT group showed improvements in only Total FSFI (P = 0.025) and Satisfaction (P < 0.0001). The number of sexual intercourses between SHT-ARE and PL was increased significantly (P = 0.001), while FSDS scores showed a significant difference in both SHT-ARE (P < 0.0001) and SHT (P = 0.008) when compared to the PL group. Improved OHQ scores in the SHT-ARE group (P