Ashwagandha Extract for Stress

Overseen By Jessie Hawkins, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Nutraceuticals Research Institute

Must not be taking: Thyroid, Hypertensive, CNS depressants, others

Disqualifiers: Pregnancy, Smoking, Alcohol, Ashwagandha, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how ashwagandha, a popular herbal supplement, affects stress levels. Researchers compare two different ashwagandha extracts to determine their effects on reducing stress, boosting brain function, increasing energy, and improving sleep. Participants will take either one of the ashwagandha extracts or a placebo (a pill with no active ingredients) for 60 days. The study seeks women aged 30 to 59 who feel highly stressed and are in good general health, without recent use of stress-related supplements or medications. As an unphased trial, it offers participants the chance to contribute to understanding the potential benefits of ashwagandha on stress.

Will 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ashwagandha root extract is generally safe for use. One study found that taking ashwagandha root extract for eight weeks did not cause any major side effects in men or women. Another study found that people tolerated it well, with no negative effects reported. However, the long-term safety of ashwagandha remains not fully understood.

Less detailed safety information exists for the extract made from both the root and leaves compared to the root extract alone. Still, ashwagandha is generally considered safe when used as a supplement. Consulting a healthcare provider before starting any new treatment is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ashwagandha extract for stress because it offers a natural alternative to traditional treatments like antidepressants and anti-anxiety medications. Unlike most medications that work by altering neurotransmitter levels, ashwagandha is an adaptogen, which means it helps the body manage stress more efficiently. The root and leaf extract might provide a broader range of benefits, potentially enhancing its stress-reducing effects. Additionally, as a plant-based supplement, it could have fewer side effects, making it a promising option for those seeking a more holistic approach to stress management.

What evidence suggests that this trial's treatments could be effective for stress?

Research has shown that ashwagandha extract can help reduce stress and anxiety. A review of nine studies involving 558 people found that ashwagandha significantly lowered stress, anxiety, and cortisol levels compared to a placebo. In this trial, participants will be assigned to different arms to evaluate the effects of ashwagandha. One arm will receive an ashwagandha root supplement, while another will receive an ashwagandha root and leaf supplement. A placebo arm will also be included for comparison. Another study found that ashwagandha root extract improved stress-related scores, meaning participants felt less stressed. Additionally, ashwagandha may help improve sleep quality and reduce tiredness. These findings suggest that ashwagandha could be a useful option for managing stress and its effects. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Good general health as evidenced by medical history and screening

Baseline score of above-average stress levels on the NRI-SS

Exclusion Criteria

Positive COVID-19 test within 30 days of the study period

Consumes > 8 alcoholic beverages in an average week

I use products or follow a diet to help with stress.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take one of two ashwagandha extracts or a placebo daily for 60 days

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ashwagandha Extract

Trial Overview

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.

How Is the Trial Designed?

Group I: Plant Extract 2 Experimental Treatment 1 Intervention

Participants in this arm will take an ashwagandha root and leaf supplement each day for 60 days.

Group II: Plant Extract 1 Experimental Treatment 1 Intervention

Participants in this arm will take an ashwagandha root supplement each day for 60 days.

Group III: Placebo Placebo Group 1 Intervention

Participants in this arm will take an inert placebo each day for 60 days.

Who Is Running the Clinical Trial?

Nutraceuticals Research Institute

Lead Sponsor

Trials

19

Recruited

3,700+

Published Research Related to This Trial

In a randomized, double-blind, placebo-controlled study involving 80 healthy adults, Ashwagandha root extract (300 mg twice daily for 8 weeks) was found to be safe, with no significant adverse effects or changes in vital signs, hematological, or biochemical parameters.

The study supports the traditional use of Ashwagandha in Ayurvedic medicine, indicating it can be consumed safely by both males and females, although further research is needed to explore long-term effects and different dosages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Ashwagandha Root Extract: A Randomized, Placebo-Controlled, study in Healthy Volunteers. Verma, N., Gupta, SK., Tiwari, S., et al.[2021]

In a study of 60 healthy adults experiencing perceived stress, supplementation with Ashwagandha (400 mg/d and 225 mg/d) for 30 days led to significant improvements in cognitive performance, including cognitive flexibility and visual memory, compared to a placebo group.

Both Ashwagandha groups showed significant reductions in cortisol levels over time, indicating a potential physiological benefit in managing stress, with no reported adverse events, suggesting safety in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Withania somnifera supplementation on adult's cognition and mood. Remenapp, A., Coyle, K., Orange, T., et al.[2022]

In an eight-week study with 60 participants, Ashwagandha root extract significantly reduced perceived stress and anxiety levels, particularly at doses of 250 mg and 600 mg per day.

Participants taking Ashwagandha also experienced improved sleep quality and lower serum cortisol levels, indicating its potential as an effective natural remedy for stress-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults: A Double-blind, Randomized, Placebo-controlled Clinical Study. Salve, J., Pate, S., Debnath, K., et al.[2020]

A 90-day study on Wistar rats found that KSM-66 Ashwagandha Root Extract (ARE) was safe at doses up to 2000 mg/kg body weight/day, establishing this as the no observed adverse effect level (NOAEL).

The study involved comprehensive assessments of toxicity, including clinical signs, body weight, food consumption, and organ health, indicating that KSM-66 ARE does not pose significant health risks at the tested doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ninety-day repeated dose toxicity of Ashwagandha (Withania somnifera) root extract in Wistar rats. Kalaivani, P., Siva, R., Gayathri, V., et al.[2023]

Ashwagandha supplementation significantly reduced anxiety and stress levels in a systematic review of 12 randomized clinical trials involving 1,002 participants, with effect sizes indicating strong benefits compared to placebo.

The analysis suggested that doses of Ashwagandha up to 12,000 mg/day for anxiety and 300-600 mg/day for stress were effective, but the overall certainty of the evidence was low, highlighting the need for more rigorous studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Ashwagandha supplementation have a beneficial effect on the management of anxiety and stress? A systematic review and meta-analysis of randomized controlled trials. Akhgarjand, C., Asoudeh, F., Bagheri, A., et al.[2022]

In a 60-day study involving 60 adults, ashwagandha extract significantly reduced anxiety levels as measured by the Hamilton Anxiety Rating Scale, indicating its potential as an effective anxiolytic treatment.

The study also found that ashwagandha supplementation led to significant reductions in morning cortisol and DHEA-S levels, suggesting its stress-relieving effects may be linked to its influence on the body's stress response system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract: A randomized, double-blind, placebo-controlled study. Lopresti, AL., Smith, SJ., Malvi, H., et al.[2022]

In a double-blind, randomized, placebo-controlled study involving 130 healthy adults, taking a daily 300 mg capsule of Ashwagandha root extract for 90 days significantly improved memory recall and reduced stress levels, as indicated by lower scores on the Perceived Stress Scale (PSS-10).

Participants taking Ashwagandha SR also reported better sleep quality and overall psychological well-being, with no adverse events noted, highlighting its safety and efficacy as a stress-reducing intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Ashwagandha Root Extract on Cognitive Functions in Healthy, Stressed Adults: A Randomized, Double-Blind, Placebo-Controlled Study. Gopukumar, K., Thanawala, S., Somepalli, V., et al.[2022]

Citations

1.

ods.od.nih.gov

ods.od.nih.gov/factsheets/Ashwagandha-HealthProfessional/

Ashwagandha: Is it helpful for stress, anxiety, or sleep?

Evidence from a small number of studies suggests that taking ashwagandha extract may improve several aspects of sleep, including sleep quality, ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1550830724001691

Effects of Ashwagandha (Withania Somnifera) on stress ...

Ashwagandha significantly reduced stress, anxiety, and cortisol levels compared to placebo in meta-analysis of 9 studies (558 patients).

3.

nutritionandmetabolism.biomedcentral.com

nutritionandmetabolism.biomedcentral.com/articles/10.1186/s12986-025-00902-7

a review of its mechanisms, health benefits, and role in sports ...

A standardized ashwagandha root extract alleviates stress, anxiety, and improves quality of life in healthy adults by modulating stress ...

4.

journals.lww.com

journals.lww.com/md-journal/fulltext/2019/09130/an_investigation_into_the_stress_relieving_and.67.aspx

An investigation into the stress-relieving and ...

The aim of this study was to add to the current body of evidence by investigating the antistress effects and safety profile of a standardized ashwagandha root ...

5.

mdpi.com

mdpi.com/2072-6643/17/13/2143

Ashwagandha (Withania somnifera) and Its Effects on Well- ...

It was shown that administering 500 mg of ashwagandha root extract caused significant improvements in the Perceived Stress Scale (PSS) and GAD-7 scale, a ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0965229920319099

Safety of Ashwagandha Root Extract: A Randomized, ...

The present study revealed that the consumption of Ashwagandha root extract for 8 weeks was safe in both males and females volunteers.

7.

webmd.com

webmd.com/vitamins/ai/ingredientmono-953/ashwagandha

Ashwagandha - Uses, Side Effects, and More

When taken by mouth: Ashwagandha is possibly safe when used for up to 3 months. The long-term safety of ashwagandha is not known. Large doses of ashwagandha ...

8.

ayush.gov.in

ayush.gov.in/images/domains/quality_standards/safetyReportAshwagandha.pdf

Safety of Ashwagandha

However, the World Health Organization (2009), in its monograph on Ashwagandha, mentioned that there is a lack of safety data and cautioned its ...

9.

frontiersin.org

frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1572025/full

Reproductive and developmental safety assessment of ...

The findings of this investigation demonstrate the remarkable safety profile of orally administered Ashwagandha root extract, with a No Observed Adverse Effect ...