Safety and efficacy of ashwagen (a standardized withania somnifera extract) in stress and anxiety with hypertension and associated cardiometabolic risk factors: a randomized, placebo-controlled trial
Pattojoshi A, Kumar Patra S, Idrees SA, Behera S, Dalua SS, Tiwari P, Valavan R
Stress (Amsterdam, Netherlands) · 0 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2026-05-09 · Stress · vol. 29 · número 1 · pág. 2669544
- Editorial
- Informa
- Citado
- 0 citas · más que el 33% de estudios similares · 0.0× el promedio de su campo
- Referencias
- 20 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY-NC
- Áreas de investigación
- Phytochemicals and Medicinal Plants · Medicinal Plant Extracts Effects · Medicinal Plants and Bioactive Compounds
- Palabras clave
- Withania somnifera, ashwagandha extract, anxiety, hypertension, cardiometabolic risk factors, cortisol, hypothalamic-pituitary-adrenal axis, adaptogenic herbs, anxiolytic effects, integrative medicine, adjunctive therapy, sleepiness, fatigue
- MeSH
- humans, withania, hypertension, anti-anxiety agents, plant extracts, treatment outcome, double-blind method, stress, psychological, anxiety, adult, middle aged, female, male, cardiometabolic risk factors
7 autores
- Amrit Pattojoshi🇮🇳Hi-Tech Medical College & Hospital
- Sudeep Kumar Patra
- S A Idrees🇮🇳Hi-Tech Medical College & Hospital
- Saiprasanna Behera
- Snigdha Suman Dalua
- Poorva Tiwari
- Ramachandran Valavan · autor de correspondencia
Resumen
El texto original del estudio, en el idioma en que se publicó.
Stress and anxiety are prevalent mental health conditions that often coexist with cardiovascular comorbidities, resulting in a complex interplay between psychological and physiological processes, partly mediated through activation of the hypothalamic-pituitary-adrenal (HPA) axis. Ashwagen®, a standardized extract of Withania somnifera (Ashwagandha), has demonstrated adaptogenic and anxiolytic properties in preclinical and clinical studies. This study aimed to evaluate the safety and efficacy of Ashwagen® in managing stress and anxiety in patients with pre-existing hypertension and associated cardiometabolic risk factors. A randomized, double-blind, placebo-controlled Phase III clinical trial was conducted over 60 days in 60 patients diagnosed with stress, anxiety, and pre-existing hypertension with cardiometabolic risk profiles. Participants received either Ashwagen® (300 mg capsule) or placebo twice daily. Efficacy assessments included validated psychological scales-Hamilton Anxiety Rating Scale (HAM-A), Generalized Anxiety Disorder-7 (GAD-7), Perceived Stress Scale (PSS), Clinical Global Impression-Improvement (CGI-I), Epworth Sleepiness Scale (ESS), and Fatigue Severity Scale (FSS)-along with serum cortisol, triglycerides, LDL, and blood pressure measurements. Ashwagen® significantly reduced anxiety and stress markers compared with placebo. HAM-A, GAD-7, and PSS scores decreased by 26.94%, 50.77%, and 30.47%, respectively, in the Ashwagen® group. Cortisol levels declined by 28.99% and triglycerides by 13.00%, with favorable trends in LDL and blood pressure. No serious adverse events were reported. Ashwagen® was found to be a safe and effective adjunctive integrative intervention for stress and anxiety management in patients with pre-existing hypertension.
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