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

Trial Summary

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.

What 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. ^{1 2 3 4 5}

Is 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. ^{2 4 5 6 7}

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. ^{2 3 4 5 7}

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.

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

Good general health as evidenced by medical history and screening

I am between 30 and 59 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults: A Double-blind, Randomized, Placebo-controlled Clinical Study. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Withania somnifera supplementation on adult's cognition and mood. [2022]

4. United States 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. [2022]

5. England 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. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Ninety-day repeated dose toxicity of Ashwagandha (Withania somnifera) root extract in Wistar rats. [2023]

7. Scotland pubmed.ncbi.nlm.nih.gov

Safety of Ashwagandha Root Extract: A Randomized, Placebo-Controlled, study in Healthy Volunteers. [2021]