80 Participants NeededMy employer runs this trial

Ashwagandha for Minority Stress

DJ
Overseen ByDr. John Ademola
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: SF Research Institute, Inc.

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Ashwagandha, a natural herb, can reduce stress and improve sleep and anxiety in adults stressed by their sexual or gender minority status. Participants will take either Ashwagandha or a placebo for eight weeks, while researchers measure improvements in stress, mood, and sleep. Suitable candidates are adults aged 18 to 45 who identify as a sexual or gender minority and experience moderate to high stress related to this identity. As an unphased trial, this study provides a unique opportunity to contribute to research that may lead to better stress management solutions for sexual and gender minorities.

Do I have to stop taking my current medications?

Yes, if you are currently using anti-anxiety or sleep medications, including sleep aids, cannabis, or melatonin, you will need to stop taking them to participate in this trial.

Is there any evidence suggesting that Ashwagandha root extract is likely to be safe for humans?

Research has shown that Ashwagandha root extract is generally safe for use. One study found that taking 200 mg capsules twice daily for six months caused no negative effects. Another study confirmed the safety of Ashwagandha for up to 12 months, with no harmful effects observed.

A review of various studies found that Ashwagandha root is safer than other parts of the plant, particularly for liver and reproductive health. Additionally, a study on adults with stress and anxiety who used the extract for eight weeks found it to be safe.

Overall, these studies suggest that Ashwagandha root extract is well-tolerated when used as directed. However, individuals should monitor for any personal reactions and consult healthcare professionals if concerns arise.12345

Why are researchers excited about this trial?

Unlike the standard treatments for managing minority stress, which often involve therapy and medications like antidepressants or anxiolytics, Ashwagandha root extract stands out due to its natural origin and adaptogenic properties. This herbal remedy, taken as a 300 mg capsule twice daily, is believed to help the body manage stress by modulating the stress hormone cortisol. Researchers are excited about Ashwagandha because it offers a potentially gentler, plant-based alternative with fewer side effects, tapping into the growing interest in holistic and complementary medicine approaches.

What evidence suggests that Ashwagandha might be an effective treatment for minority stress?

This trial will compare Ashwagandha root extract with a placebo to evaluate its effects on stress and anxiety. Studies have shown that Ashwagandha root extract can effectively reduce stress and anxiety. In one study, participants taking Ashwagandha reported feeling significantly less stressed and anxious compared to those taking a placebo, which contains no active ingredients. The treatment also lowered morning cortisol, a hormone that rises with stress. Other research suggests that Ashwagandha can improve sleep quality and mental alertness. Overall, evidence indicates that Ashwagandha is a promising option for reducing stress and anxiety.26789

Are You a Good Fit for This Trial?

This trial is for adults aged 18-45 who identify as sexual or gender minorities and are experiencing moderate to high stress. Participants must not be using anxiety or sleep medications, have certain psychiatric diagnoses, allergies to Ashwagandha, or serious chronic illnesses.

Inclusion Criteria

Self-identified as a sexual or gender minority (e.g., lesbian, gay, bisexual, transgender, queer, non-binary)
Moderate to high perceived stress levels (PSS-10 total score >14)
I am between 18 and 45 years old.
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Exclusion Criteria

I have used medication for anxiety or sleep in the past 3 months.
Current psychiatric diagnosis (e.g., major depressive disorder, bipolar disorder, psychosis)
Known allergy or intolerance to Ashwagandha
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ashwagandha root extract or placebo for 8 weeks

8 weeks
3 visits (in-person) at Baseline, Week 4, and Week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ashwagandha Root Extract

Trial Overview

The study tests whether taking Ashwagandha root extract (300 mg twice daily) for 8 weeks can reduce stress and improve anxiety and sleep quality compared to a placebo. Participants are randomly assigned to either the Ashwagandha group or placebo group without knowing which they receive.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Ashwagandha Root ExtractExperimental Treatment1 Intervention
Group II: Placebo (Inactive capsule)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

SF Research Institute, Inc.

Lead Sponsor

Trials
7
Recruited
540+

Ixoreal Biomed Private Limited

Industry Sponsor

Citations

An investigation into the stress-relieving and pharmacological ...

In an 8-week, randomized, double-blind, placebo-controlled study ashwagandha was associated with greater reductions in anxiety, morning cortisol, c-reactive ...

Effect of Ashwagandha Root Extract on Stress, Anxiety, and ...

Secondary outcomes include measures of anxiety, mood, sleep quality, quality of life, minority stress experiences, and salivary cortisol levels. Safety will be ...

Ashwagandha (Withania somnifera)—Current Research on ...

Studies have suggested that Ashwagandha may exhibit cardioprotective properties, be helpful in the treatment of sleep disorders, improve stress resilience, ...

Effects of Withania somnifera Extract in Chronically ...

We have shown that aqueous WS extract (roots and leaves) safely reduces mild to moderate chronic stress at doses of 125 mg, 250 mg, and 500 mg/day for 8 weeks.

Effect of Ashwagandha Root Extract on Stress, Anxiety, and ...

This randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Ashwagandha (Withania somnifera) root ...

Safety and Tolerability of Withania somnifera Root Extract in ...

The study concluded that WS root extract (200 mg capsules twice daily for 6 months) was well‐tolerated and safe, with no adverse effects reported. graphic file ...

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

Compared with placebo, ashwagandha did not reduce perceived stress, but it did reduce fatigue. A daily dose of 300 to 600 mg ashwagandha root ...

Back to the Roots: Safety and Tolerability of Standardised ...

The aim of this systematic review is to critically evaluate and synthesise evidence on the safety and tolerability of standardised Ashwagandha root extract ( ...

Ashwagandha - Uses, Side Effects, and More

Note: The Food and Drug Administration (FDA) has not reviewed ashwagandha for safety and effectiveness, and it is not approved by the FDA. Learn ...