Age: 18 - 65
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nutraceuticals Research Institute
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on stress levels, with secondary outcomes of cognition, energy, and sleep, as compared to a placebo.
How does Ashwagandha Extract differ from other treatments for stress?
Ashwagandha Extract is unique because it is a natural herb used in Ayurvedic medicine known for its adaptogenic properties, which help the body manage stress. Unlike some conventional treatments, it is taken as a supplement and has been shown to reduce stress and anxiety levels significantly, with a favorable effect at doses between 300-600 mg per day.
23456Is Ashwagandha extract safe for humans?
Studies show that Ashwagandha extract is generally safe for humans. In a study with healthy adults, it was well-tolerated, and another study found no adverse effects at high doses in rats. However, more research is needed to confirm its safety across different conditions.
23567What data supports the effectiveness of the treatment Ashwagandha Extract for stress?
Research shows that Ashwagandha extract can significantly reduce stress and anxiety levels in adults. Studies found that taking Ashwagandha led to lower stress scores and improved well-being compared to a placebo, with effects seen at doses of 300-600 mg per day.
12456Will I have to stop taking my current medications?
The trial requires that you do not take any stress-related medications or supplements, and you must not have taken certain medications like thyroid drugs, hypertensive drugs, CNS depressants, diabetic medications, benzodiazepines, or immunosuppressants within the last 60 days.
Eligibility Criteria
This trial is for healthy women aged 30-59 with above-average stress levels who agree to lifestyle guidelines and contraception use. Excluded are those with recent COVID-19, high alcohol intake, liver/kidney disorders, allergies to ashwagandha, dramatic weight changes, new stress-reduction activities or supplements (including ashwagandha), certain medication users, smokers/vapers within a year, primary caretakers of young children.Inclusion Criteria
I am between 30 and 59 years old.
I am biologically and identify as a female.
Exclusion Criteria
I use products or follow a diet to help with stress.
I have a liver or kidney disorder.
My weight has changed significantly (10% up or down) in the last 6 months.
I have been taking ashwagandha supplements regularly in the last 2 years.
Participant Groups
The study tests the effectiveness of two proprietary ashwagandha extracts on reducing stress compared to a placebo. Secondary outcomes include improvements in cognition, energy levels, and sleep quality. Participants will be randomly assigned to receive either an extract or placebo.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Plant Extract 2Experimental Treatment1 Intervention
Participants in this arm will take an ashwagandha root and leaf supplement each day for 60 days.
Group II: Plant Extract 1Experimental Treatment1 Intervention
Participants in this arm will take an ashwagandha root supplement each day for 60 days.
Group III: PlaceboPlacebo Group1 Intervention
Participants in this arm will take an inert placebo each day for 60 days.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Nutraceuticals Research InstituteHuntsville, AL
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Who is running the clinical trial?
Nutraceuticals Research InstituteLead Sponsor
References
An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract: A randomized, double-blind, placebo-controlled study. [2022]Ashwagandha (Withania somnifera (L.) Dunal) is a herb traditionally used to reduce stress and enhance wellbeing. The aim of this study was to investigate its anxiolytic effects on adults with self-reported high stress and to examine potential mechanisms associated with its therapeutic effects.
Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults: A Double-blind, Randomized, Placebo-controlled Clinical Study. [2020]Background Stress, anxiety and impeded sleep are a frequent feature of life in modern societies. Across socio-economic strata, stress, anxiety and ineffective sleep detract from healthful living and serve as precursors of various ailments. The use of herbs to offset these antecedents and outcomes has greatly increased in recent years. Ashwagandha, an adaptogenic Ayurvedic herb, has been often used to combat and reduce stress and thereby enhance general wellbeing. While there have been other studies documenting the use of Ashwagandha for stress resistance, this is the first study to use a high-concentration root extract while also varying the dosage substantially. Therefore, this is the first study to offer insight into dose-response of a high concentration root extract. Material and methods In this eight-week, prospective, randomized, double-blind, placebo-controlled study, the stress-relieving effect of Ashwagandha root extract was investigated in stressed healthy adults. Sixty male and female participants with a baseline perceived stress scale (PSS) score >20 were randomized to receive capsules of Ashwagandha extract 125 mg, Ashwagandha extract 300 mg or identical placebo twice daily for eight weeks in a 1:1:1 ratio. Stress was assessed using PSS at baseline, four weeks and eight weeks. Anxiety was assessed using the Hamilton-Anxiety (HAM-A) scale and serum cortisol was measured at baseline and at eight weeks. Sleep quality was assessed using a seven-point sleep scale. A repeat measures ANOVA (general linear model) was used for assessment of treatment effect at different time periods. Post-hoc Dunnett's test was used for comparison of two treatments with placebo. Results Two participants (one each in 250 mg/day Ashwagandha and placebo) were lost to follow-up and 58 participants completed the study. A significant reduction in PSS scores was observed with Ashwagandha 250 mg/day (P
Safety of Ashwagandha Root Extract: A Randomized, Placebo-Controlled, study in Healthy Volunteers. [2021]Ashwagandha (Withania somnifera) is a well-established and reputed herb in Ayurvedic medicine. It has been used as a "Rasayana" (rejuvenator), nootropic, and as a powerful natural adaptogen. The herb extract is extensively used for general wellbeing and in specific ailments. However, only a few studies have investigated the safety and tolerability of Ashwagandha in humans. This study evaluated the safety of Ashwagandha root extract consumption in healthy adults.
Efficacy of Withania somnifera supplementation on adult's cognition and mood. [2022]The present study examined the effects of a proprietary Ashwagandha (Withania somnifera) root and leaf extract (NooGandha® Specnova LLC, USA) supplement for improving cognitive abilities, cortisol levels, and self-reported mood, stress, food cravings, and anxiety with adults who have perceived stress. Healthy adults (n = 43 women and n = 17 men; mean age = 34.41 years) who reported experiencing perceived stress were randomized to the following groups: Ashwagandha (400 mg/d), Ashwagandha (225 mg/d), and placebo for 30 days. The following outcomes were assessed at Day 0, Day 15, and Day 30: saliva cortisol levels, cognitive performance (i.e., CNS vital signs), and the self-reported measures of Trait Anxiety Inventory, Depression Anxiety Stress Scale, Perceived Stress Scale, and Food Cravings Questionnaire-15. For the self-report assessments, significant main effects for time were evidenced for anxiety, depression, perceived stress, and food cravings, p's
Efficacy and Safety of Ashwagandha Root Extract on Cognitive Functions in Healthy, Stressed Adults: A Randomized, Double-Blind, Placebo-Controlled Study. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">The global prevalence of stress is increasing. Stress adversely affects cognitive ability, sleep quality, and overall psychological well-being. Ashwagandha (Withania somnifera (L.) Dunal), an essential medicine in Ayurveda, is reportedly beneficial in reducing stress and improving memory. This double-blind, randomized, placebo-controlled clinical study evaluated the effect of Ashwagandha root extract sustained-release capsule 300 mg (Prolanza™; hereafter Ashwagandha SR) on cognitive functions, stress levels, sleep quality, overall well-being, and safety in stressed subjects.
Does Ashwagandha supplementation have a beneficial effect on the management of anxiety and stress? A systematic review and meta-analysis of randomized controlled trials. [2022]Clinical trial studies revealed conflicting results on the effect of Ashwagandha extract on anxiety and stress. Therefore, we aimed to evaluate the effect of Ashwagandha supplementation on anxiety as well as stress. A systematic search was performed in PubMed/Medline, Scopus, and Google Scholar from inception until December 2021. We included randomized clinical trials (RCTs) that investigate the effect of Ashwagandha extract on anxiety and stress. The overall effect size was pooled by random-effects model and the standardized mean difference (SMD) and 95% confidence interval (CIs) for outcomes were applied. Overall, 12 eligible papers with a total sample size of 1,002 participants and age range between 25 and 48 years were included in the current systematic review and meta-analysis. We found that Ashwagandha supplementation significantly reduced anxiety (SMD: -1.55, 95% CI: -2.37, -0.74; p = .005; I2  = 93.8%) and stress level (SMD: -1.75; 95% CI: -2.29, -1.22; p = .005; I2  = 83.1%) compared to the placebo. Additionally, the non-linear dose-response analysis indicated a favorable effect of Ashwagandha supplementation on anxiety until 12,000 mg/d and stress at dose of 300-600 mg/d. Finally, we identified that the certainty of the evidence was low for both outcomes. The current systematic review and dose-response meta-analysis of RCTs revealed a beneficial effect in both stress and anxiety following Ashwagandha supplementation. However, further high-quality studies are needed to firmly establish the clinical efficacy of the plant.
Ninety-day repeated dose toxicity of Ashwagandha (Withania somnifera) root extract in Wistar rats. [2023]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.