Ashwagandha for Anxiety

Overseen By John Ademola

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SF Research Institute, Inc.

Must not be taking: Corticosteroids, Antidepressants, Antipsychotics, others

Disqualifiers: Depression, PTSD, GAD, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

51 Participants Needed

Trial Summary

Do I have to stop taking my current medications to join the trial?

Yes, you must stop taking any medications known to affect stress and anxiety for at least 4 weeks before joining the trial. This includes corticosteroids, antidepressants, antipsychotics, mood stabilizers, and anti-epileptic medications. However, occasional use of analgesics and contraceptive pills is allowed.

What data supports the idea that Ashwagandha for Anxiety is an effective treatment?

The available research shows that Ashwagandha can be an effective treatment for anxiety. In one study, 88.2% of patients taking Ashwagandha showed improvement compared to 50% in the placebo group after six weeks. Another review of multiple studies found that Ashwagandha significantly reduced anxiety and stress levels compared to a placebo. However, the certainty of the evidence was considered low, and more high-quality studies are needed to confirm these findings. ^{1 2 3 4 5}

What safety data exists for Ashwagandha in treating anxiety?

Several studies have evaluated the safety of Ashwagandha (Withania somnifera) for anxiety. A randomized, placebo-controlled study confirmed its safety in healthy adults. Another study on insomnia and anxiety found Ashwagandha root extract to be well-tolerated at a dose of 300 mg twice daily over 10 weeks. A systematic review and meta-analysis of randomized controlled trials also supported its safety, although the certainty of evidence was low. Overall, Ashwagandha is considered safe, but further high-quality studies are needed to confirm its clinical efficacy and safety profile. ^{2 3 4 6 7}

Is Ashwagandha a promising treatment for anxiety?

Yes, Ashwagandha is a promising treatment for anxiety. Studies show it can significantly reduce anxiety levels and improve overall wellbeing. It has been used traditionally and recent research supports its effectiveness in reducing stress and anxiety. ^{2 3 7 8 9}

What is the purpose of this trial?

This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women with High Stress and Anxiety. All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study. Subjects will be informed about the purpose of the study and signed informed consent will be taken. Subjects will be randomized to either one of the three treatment arms. Subjects will then be asked to either take one capsule containing the proprietary blend of Ashwagandha root extract or Ashwagandha root extract or Placebo orally twice daily with a glass of water for 8 weeks. The primary objective is to compare the efficacy of a proprietary blend of Ashwagandha root extract in adults experiencing stress and anxiety. The secondary objective is to compare the safety of a proprietary blend versus KSM-66 versus Placebo in adults experiencing stress and anxiety.

Eligibility Criteria

Adult men and women experiencing high levels of stress and anxiety can join this trial. They must understand the study's purpose, agree to take capsules twice daily for 8 weeks, and sign a consent form. Specific details on who can't participate are not provided.

Inclusion Criteria

BMI between 20 and 35

Must have the ability and willingness to sign an informed consent and to comply with all study procedures

I am experiencing symptoms like anxiety, insomnia, or fatigue, which suggest I might be under stress.

Exclusion Criteria

Pregnant and lactating women or suspected to be pregnant

Patients who have any clinical condition, according to the investigator, that does not allow safe fulfilment of clinical trial protocol

I do not have severe liver, kidney, heart, or lung problems that would stop me from joining the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive the study medication (Ashwagandha or placebo) twice daily for 8 weeks

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Proprietary Blend of Ashwagandha Root Extract

Trial Overview The trial is testing the effectiveness of two forms of Ashwagandha root extract against a placebo in reducing stress and anxiety over an 8-week period. Participants will be randomly assigned to one of three groups: proprietary blend, KSM-66 extract, or placebo.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

One capsule of Proprietary Blend of Ashwagandha 300 mg twice a day, orally with water.

Group II: Comparator Group Experimental Treatment 1 Intervention

One capsule of KSM-66 Ashwagandha 300mg two times a day, orally with water

Group III: Control Group Placebo Group 1 Intervention

One capsule of Placebo two times a day, orally with water

Proprietary Blend of Ashwagandha Root Extract is already approved in India, United States for the following indications:

Approved in India as Ashwagandha for:

• Stress relief
• Anxiety reduction
• Sleep improvement

Approved in United States as Ashwagandha for:

• Stress relief
• Anxiety reduction
• Sleep improvement

Who Is Running the Clinical Trial?

SF Research Institute, Inc.

Lead Sponsor

Trials

7

Recruited

540+

Agaja Pharma Pvt. Ltd.

Collaborator

Trials

1

Recruited

50+

Findings from Research

In a double-blind, placebo-controlled study involving 39 patients with anxiety disorders, the ethanolic extract of Aswagandha showed significant efficacy, with 88.2% of patients in the treatment group meeting response criteria at 6 weeks compared to 50% in the placebo group.

The extract was well-tolerated, with no significant increase in adverse effects compared to the placebo, suggesting it is a safe option for anxiety treatment and warrants further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled evaluation of the anxiolytic efficacy ff an ethanolic extract of withania somnifera. Andrade, C., Aswath, A., Chaturvedi, SK., 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 systematic review of five human trials found that Withania somnifera (ashwagandha) significantly reduced anxiety and stress levels compared to placebo, with notable improvements in scores on the Hamilton Anxiety Scale and Perceived Stress Scale.

Despite the positive findings, the studies had high risks of bias and varied methodologies, suggesting that while ashwagandha shows promise as an anxiety treatment, further research is needed to confirm its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An alternative treatment for anxiety: a systematic review of human trial results reported for the Ayurvedic herb ashwagandha (Withania somnifera). Pratte, MA., Nanavati, KB., Young, V., et al.[2018]

Ashwagandha (Withania somnifera) is gaining popularity as a nonprescription remedy for stress and anxiety, showing potential therapeutic benefits, although clinical trials present mixed results due to variability in product quality.

Healthcare professionals should be aware of the inconsistencies in Ashwagandha products and their safety profiles, as well as the evidence supporting their use in stress reduction, to better inform patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Let's Get to the Root of Ashwagandha: What Health Care Professionals Need to Know. Goldin, D., Salani, D.[2023]

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 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]

A randomized, double-blind, placebo-controlled study with 60 patients showed that Ashwagandha root extract (300 mg twice daily) significantly improved sleep onset latency and sleep quality compared to a placebo after 10 weeks.

The study found that Ashwagandha was well tolerated and also led to significant improvements in anxiety levels, suggesting it could be a safe and effective alternative for treating insomnia and anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Insomnia and Anxiety: A Double-blind, Randomized, Placebo-controlled Study. Langade, D., Kanchi, S., Salve, J., et al.[2020]

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 90-day randomized, double-blind placebo-controlled study involving 70 participants, Ashwagandha root extract (ARE) significantly improved symptoms of depression and anxiety, as measured by the Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale, compared to placebo.

ARE was well tolerated with no adverse effects reported, and it increased serum serotonin levels, which may contribute to its effectiveness in enhancing mood and reducing anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Standardized Withania somniferra (Linn.) Root Extract with Piperine Alleviates the Symptoms of Anxiety and Depression by Increasing Serotonin Levels: A Double-Blind, Randomized, Placebo-Controlled Study. Majeed, M., Nagabhushanam, K., Murali, A., et al.[2023]

References

1. India pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled evaluation of the anxiolytic efficacy ff an ethanolic extract of withania somnifera. [2022]

2. 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]

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

An alternative treatment for anxiety: a systematic review of human trial results reported for the Ayurvedic herb ashwagandha (Withania somnifera). [2018]

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

Let's Get to the Root of Ashwagandha: What Health Care Professionals Need to Know. [2023]

5. 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]

6. Scotland pubmed.ncbi.nlm.nih.gov

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

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

Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Insomnia and Anxiety: A Double-blind, Randomized, Placebo-controlled Study. [2020]

8. 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]

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

A Standardized Withania somniferra (Linn.) Root Extract with Piperine Alleviates the Symptoms of Anxiety and Depression by Increasing Serotonin Levels: A Double-Blind, Randomized, Placebo-Controlled Study. [2023]