Evaluating the effects of Ashwagandha on stress and anxiety in adults

Efficacy and Safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women With High Stress and Anxiety: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study

This study is testing if a special Ashwagandha supplement can help adults aged 18 to 55 who are feeling stressed and anxious feel better compared to a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 51 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: SF Research Institute, Inc. (Research network)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06714942 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of a proprietary blend of Ashwagandha root extract in adults experiencing high levels of stress and anxiety. Participants aged 18 to 55 will be randomly assigned to receive either the proprietary blend, KSM-66 Ashwagandha, or a placebo for a duration of 8 weeks. The study will involve assessments of participants' medical history, physical exams, blood samples to analyze cortisol levels, and self-assessments using the Hamilton Anxiety Rating Scale and Perceived Stress Scale. The primary goal is to compare the effectiveness of the Ashwagandha treatments against placebo in alleviating stress and anxiety symptoms.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 55 who are experiencing significant stress and anxiety symptoms.

Not a fit: Patients currently taking medications that affect stress and anxiety may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a natural treatment option for individuals suffering from stress and anxiety.

How similar studies have performed: Other studies have shown promising results with Ashwagandha for stress and anxiety, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Adults (male and female) aged between 18 and 65 years.
2. Experiencing signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.).
3. Hamilton Anxiety Rating Scale (HAM-A) total score between 14 and 30 at the screening/randomization visit.
4. Perceived Stress Scale (PSS) score ≥13 at the screening/randomization visit.
5. BMI between 20 and 35.
6. No plan to commence new treatments over the study period.
7. Medication-free (any medications are known to affect stress and anxiety) for at least 4 weeks. Use of analgesics (once a week) or contraceptive pills are permissible.
8. Must have the ability and willingness to sign an informed consent and to comply with all study procedures.

Exclusion Criteria:

1. Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, antipsychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to screening.
2. Patients having a total score of less than 14 on HAM-A at screening.
3. Patients currently (or within the past 4 weeks prior to screening) taking any over-the-counter use of herbal extracts such as Ginkgo Biloba, St. John's Wort, Omega-3, etc.
4. Patients with a depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia, and mania.
5. Patients with known post-traumatic stress disorder (PTSD) and Generalized Anxiety Disorder (GAD).
6. Patients who have an established practice of meditation and relaxation techniques for three or more months.
7. Patients with known clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study.
8. Patients with a history of alcohol, tobacco dependence, or any substance abuse.
9. Pregnant and lactating women or suspected to be pregnant.
10. Patients with known hypersensitivity to Ashwagandha.
11. Patients who had participated in other clinical trials during the previous 3 months.
12. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.

Where this trial is running

San Francisco, California

• San Francisco Research Institute — San Francisco, California, United States (Recruiting)

Study contacts

• Study coordinator: John Ademola

Conditions Stress; Anxiety