Table 1_Efficacy and safety of Ashwagandha (Withania somnifera) root extract in pregnant women: a prospective, randomized, comparative, open-label, 12-week study.docx

IntroductionPregnancy is associated with increased risk of anemia, high psychological stress, and sleep disturbances, yet safe therapeutic options remain limited. Ashwagandha (Withania somnifera) root extract (ARE) possesses adaptogenic and hematopoietic potential, but evidence in pregnant women is scarce. The aim of the current study is to evaluate the efficacy and safety of ARE on hematological parameters and on stress, sleep quality, and laboratory safety markers in pregnant women.
MethodsThis 12-week, prospective, randomized, open-label, comparative trial enrolled 70 pregnant women in the second trimester. Participants received either ARE 300 mg twice daily plus standard hematinic therapy or standard hematinic therapy (standard of care; SOC) alone. Primary endpoints included changes in hemoglobin (Hb) and red blood cell (RBC) indices. Secondary endpoints included perceived stress, sleep quality, and safety assessments (adverse events, liver, renal, cardiac, and thyroid markers). Efficacy was analyzed in the per-protocol population; safety in the intention-to-treat population.
ResultsOf 70 randomized participants, 63 completed the study (ARE: n = 32; SOC: n = 31). ARE supplementation produced significant improvements in hematological parameters: Hb increased by 1.06 ± 0.44 g/dL vs. 0.78 ± 0.24 g/dL with SOC (between-group difference 0.28 g/dL; p = 0.003), mean corpuscular hemoglobin concentration improved significantly (difference 0.73 g/dL; p = 0.017), and red cell distribution width decreased markedly (difference −0.57%; p < 0.001). RBC count and hematocrit showed favorable but non-significant trends. ARE significantly reduced perceived stress at Week 12 (–10.50 vs. −5.35; p < 0.001) and improved key sleep parameters, including subjective sleep quality at all visits (p = 0.036), sleep duration (Week 8 and 12; p < 0.001), and sleep disturbances (Week 12; p = 0.028). No adverse events or serious adverse events occurred. Laboratory evaluations showed no detrimental effects on hepatic, renal, or thyroid function.
DiscussionARE supplementation for 12 weeks improved hemoglobin levels, RBC quality, perceived stress, and multiple aspects of sleep in pregnant women, with no adverse events and stable organ-function markers. ARE appears to be a tolerable and suitable adjunct to standard prenatal care for supporting hematological and psychological well-being during pregnancy.

Clinical Trial Registrationhttps://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTIyNjQ2&Enc=&userName=, identifier CTRI/2025/01/079238 on January 22, 2025.