Effects of multi-herb and ashwagandha root formulas on stress modulation: a randomized, double-blind, placebo-controlled clinical study
McKinney E, Stewart J, Kewalramani R, Singh S
Trials · 0 citas
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Cómo se estudió
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- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
- Autores
- Al menos un autor declara un vínculo económico con la industria
Según la declaración de financiación del texto completo.
Publicación
- Publicado
- 2026-02-09 · Trials · vol. 27 · número 1
- Editorial
- Springer Science+Business Media
- Citado
- 0 citas · más que el 7% de estudios similares · 0.0× el promedio de su campo
- Referencias
- 30 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY-NC-ND
- Áreas de investigación
- Medicinal Plants and Bioactive Compounds · Phytochemicals and Medicinal Plants · Medicinal Plant Extracts Effects
- Palabras clave
- chronic stress, adaptogens, ashwagandha root, Withania somnifera, Rhodiola rosea, Ocimum sanctum, Schisandra chinensis, herbal formula, hypothalamic-pituitary-adrenal axis, perceived stress, sleep quality, fatigue, anxiety, mood dysregulation, mental alertness, restorative sleep, Ayurveda
- MeSH
- humans, schisandra, plant roots, plant extracts, treatment outcome, double-blind method, stress, psychological, affect, sleep, time factors, adolescent, adult, aged, middle aged, female, male, young adult, sleep quality
4 autores
- Erin McKinney🇺🇸Gaia Herbs (United States)
- Jeremy Stewart🇺🇸Gaia Herbs (United States)
- Kewalramani RM
- Sonali Singh🇮🇳 · autor de correspondenciaVedic Lifesciences (India)
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Chronic stress is detrimental to the maintenance of the main response system - the hypothalamic-pituitary-adrenal (HPA) axis. The current study aimed to investigate the efficacy of two plant-based adaptogens, a formula containing Rhodiola, holy basil and Schisandra chinensis (VL-G-A57) and a full-spectrum ashwagandha (VL-G-E12), on stress and related symptoms in individuals with high stress.
Materials and methods
The 60-day randomized, double-blind, placebo-controlled clinical study included individuals aged between 18 to 65 years with a body mass index (BMI) of 18 to 29.9 kg/m2. One hundred eighty-six participants were randomized to one of the adaptogens, VL-G-A57 or VL-G-E12, or to placebo. The primary outcome was a reduction in stress levels. Secondary outcomes were changes in sleep quality, fatigue, restorative sleep, mental alertness, mood dysregulation, and anxiety. A priori power analysis determined the required sample size. Efficacy was assessed by comparing mean changes in the primary endpoint at days 30 and 60 using ANCOVA, with baseline values as covariates. Dunnett's post hoc test identified significant differences versus placebo, and within-group changes were evaluated using paired t-tests. Normality was assessed visually and via Shapiro-Wilk/Kolmogorov-Smirnov tests as needed. Secondary outcomes were analyzed similarly. Analyses were conducted using R (v4.0.5) and XLSTAT (v2021.3.1).
Results
At day 60, both VL-G-A57 and VL-G-E12 significantly reduced Perceived Stress Scale (PSS) scores compared to placebo (p < 0.0001). Sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI), improved significantly in both adaptogen groups (VL-G-A57: p = 0.0008, VL-G-E12: p < 0.0001). This corresponded well with the Restorative Sleep Questionnaire-Weekly (RSQ-W) results in the two IP arms when compared with placebo (p < 0.0001). Additionally, mood dysregulation (VL-G-A57: p = 0.0454), anxiety (VL-G-A57: p = 0.0004, VL-G-E12: p = 0.0015), and stress levels (VL-G-A57-VL-G-E12: p < 0.0001) showed significant improvements compared to placebo. No differences in mental alertness were observed.
Conclusion
The study concluded that both VL-G-A57 and VL-G-E12 were associated with reductions in stress, fatigue, and anxiety while improving mood and sleep quality.
Trial registration
ClinicalTrials.gov NCT05602389 and the Clinical Trials Registry - India CTRI/2022/11/047635. Registered on 1 November 2022 and 24 November 2022.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC-ND).
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