KSM-66 Ashwagandha

INTRODUCTION: Pregnancy 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. METHODS: This 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. RESULTS: Of 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. DISCUSSION: ARE supplementation for 12 weeks improved hemoglobin levels, RBC quality, perceived stress, and multiple aspects of sleep in pregnan

BACKGROUND: Alopecia is a dermatological condition affecting genders, negatively impacting their personality and quality of life (QoL). The current approved entities are limited, inconsistently effective, and associated with negative side effects. To alleviate this issue, ayurvedic herbs such as Ashwagandha have being explored. As a result, this study was designed to evaluate the efficacy and safety of Ashwagandha (root extract) topical formulation (serum) on hair health in healthy adults. METHODS: In this prospective, double-blind, randomized, placebo controlled, two arm, parallel, comparative study, the effects of topical Ashwagandha on the hair health was evaluated. Healthy adults between 18 and 45 years with mild to moderate hair loss were randomized to either Ashwagandha (topical) or Placebo (topical) treatment. The participants were assessed at Day-1 and Day-75 for change in efficacy parameters, which included 60 Seconds Hair Comb, Trichoscan analysis, Hair Pull test, Investigator's Global Assessment (IGA) and QoL using Hair-specific Skindex-29. RESULTS: In the per protocol analysis of 61 participants, Ashwagandha group demonstrated significant reduction in hair shedding in the 60 Seconds Hair Comb test compared to Placebo at day 75. Similarly, Ashwagandha substantially enhanced hair density, growth, and thickness compared to the Placebo group (density = 7.3 vs. 2.8, P < 0.001; growth = 21.7 vs. 4.2, P < 0.001; thickness = 1.8 vs. 0.9, P < 0.001). In addition, Ashwagandha significantly improved QOL compared to placebo (Score = -17.3 vs. -6.1, P = 0.011). CONCLUSION: The study found that topical Ashwagandha (serum) improved hair growth and hair health indicators. Thus, it can be an effective and safer alternative for alopecia. STUDY REGISTRATION: CTRI, Number CTRI/2022/11/047539, Registered on: 23/11/2022.

Many pharmacological studies have been carried out to describe multiple biological properties of Ashwagandha (Withania somnifera) and the additional safety information on repeated dose toxicity is limited. Therefore, the aim of this study was to obtain safety data for KSM-66 Ashwagandha Root Extract (ARE) through repeated-dose toxicity in Wistar rats according to the Organisation for Economic Co-operation and Development (OECD) test guideline (TG 408). ARE was orally administered to rats at doses of 0, 500, 1000, and 2000 mg/kg body weight/day for 90-day and reversibility of effects of 0 and 2000 mg/kg body weight/day was assessed for 14 days. All the animals from treated, control, recovery control and recovery groups were observed for clinical signs of toxicity once daily, detailed clinical examination every week after dosing and before necropsy day. Mortality/Morbidity was observed twice daily. In addition, observations were noted in the detailed sensory reactivity, functional assessments, body weight, food consumption, ophthalmological examination, hematological parameters, biochemical parameters, organ weights, histopathological findings. The present results show that the no observed adverse effect level (NOAEL) of KSM-66 Ashwagandha Root Extract was considered to be 2000 mg/kg body weight/day in rats after repeated oral administration for 90-day under the present study conditions. © 2023 The Authors.

Parkinson's disease is the most frequent neurodegenerative motor disorder. The clinical syndrome and pathology involve motor disturbance and the degeneration of dopaminergic neurons in the substantia nigra. Root extracts of Withania. somnifera, commonly called Ashwagandha, contain several major chemical constituents known as withanolides. Studies have shown that W. somnifera extracts exhibit numerous therapeutic effects including inflammation and oxidative stress reduction, memory and cognitive function improvement. This study aimed to evaluate the protective effects of KSM-66, W. somnifera root extract, on 6-hydroxydopamine (6-OHDA)-induced toxicity in the human neuroblastoma SH-SY5Y cell line, as well as the associated oxidative response protein expression and redox regulation activity focused on S-glutathionylation. SH-SY5Y cells were treated with 6-OHDA preceded or followed by treatment with the KSM-66 extract. Using KSM-66 concentrations ranging from 0.25 to 1 mg/ml before and after treatment of the cells with 6-OHDA has resulted in an increased viability of SH-SY5Y cells. Interestingly, the extract significantly increased glutathione peroxidase activity and thioltransferase activity upon pre- or post- 6-OHDA treatment. KSM-66 also modulated oxidative response proteins: peroxiredoxin-I, VGF and vimentin proteins upon 6-OHDA pre/post treatments. In addition, the extract controlled redox regulation via S-glutathionylation. Pre-treatment of SH-SY5Y cells with KSM-66 decreased protein-glutathionylation levels in the cells treated with 6-OHDA. The rescue of mitochondria with 0.5 mg/ml KSM-66 extract showed an increase in ATP levels. These findings suggest that W. somnifera root extract acts as a neuroprotectant, thereby introducing a potential agent for the treatment or prevention of neurodegenerative diseases. © 2021 The Author(s).

INTRODUCTION: Ashwagandha (Withania somnifera [L.] Dunal) has been traditionally used for various actions ranging from vitalizer, improve endurance and stamina, promote longevity, improve immunity, and male and female fertility. However, clinical studies are needed to prove the clinical efficacy of this herb, especially in cardiovascular endurance and physical performance. AIMS: This prospective, double-blind, randomized, and placebo-controlled study evaluated the efficacy of Ashwagandha roots extract in enhancing cardiorespiratory endurance and improving the quality of life (QOL) in 50 healthy male/female athletic adults. MATERIALS AND METHODS: Cardiorespiratory endurance was assessed by measuring the oxygen consumption at peak physical exertion (VO2 max) levels during a 20 m shuttle run test. The World Health Organization self-reported QOL questionnaire (physical health, psychological health, social relationships, and environmental factors) was used to assess the QOL. Student's t-test was used to compare the differences in a mean and change from baseline VO2 max levels, whereas Wilcoxon signed-rank test was used to assess changes in QOL scores from baseline in the two groups. RESULTS: There was a greater increase from baseline (P < 0.0001) in the mean VO2 max with KSM-66 Ashwagandha (n = 24) compared to placebo (n = 25) at 8 weeks (4.91 and 1.42, respectively) and at 12 weeks (5.67 and 1.86 respectively). The QOL scores for all subdomains significantly improved to a greater extent in the Ashwagandha group at 12 weeks compared to placebo (P < 0.05). CONCLUSION: The findings suggest that Ashwagandha root extract enhances the cardiorespiratory endurance and improves QOL in healthy athletic adults.