Prospective, Multi Centric, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KSM-66 Ashwagandha (Withania Somnifera) in Adults Experiencing High Stress and/or Anxiety

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Anxiety, Stress

In brief

This study is a multi-centre, multi-national, prospective, randomized, double-blind placebo-controlled study. The study lasts 12 weeks which includes 2 on-site visits and 2 remote visits. Primary objective is to compare the efficacy of KSM-66 Ashwagandha (Withania somnifera) versus placebo in adults experiencing high stress and/or anxiety. Secondary objectives to compare the safety of KSM-66 Ashwagandha (Withania somnifera) versus placebo in adults experiencing high stress and/or anxiety.

Key facts

Study ID

NCT05684991

Run by

SF Research Institute, Inc.

People needed

50

Starts

2022-09-19

Expected to finish

2023-01-31

Last updated by the study team

2023-01-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults (male and female) aged between 18 and 65 years
• Experiencing signs and symptoms suggestive of high stress (e.g., difficulty concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion etc.)
• Hamilton Anxiety Rating Scale (HAM-A) total score between14 and 30 at the screening/randomization visit
• Perceived Stress Scale (PSS) score ≥13 at the screening/randomization visit
• BMI between 20 and 35
• No plan to commence new treatments over the study period
• Non-smoker
• Medication-free (any medications known to affect stress and anxiety) for at least 4 weeks. Use of analgesics (once a week) or contraceptive pill are permissible.
• Must have the ability and willingness to sign an informed consent and to comply with all study procedures.

You may not qualify if…

• 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.
• Patients having total score less than 14 on HAM-A at screening.
• 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.
• Patients with depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania
• Patients with known post-traumatic stress disorder (PTSD) 6. Patients who have an established practice of meditation and relaxation techniques for three or more months
• Patients with known clinically significant acute unstable hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study
• Patients with history of alcohol, tobacco dependence or with any substance abuse
• Pregnant and lactating women or suspected to be pregnant
• Patients with known hypersensitivity to Ashwagandha
• Patients who had participated in other clinical trials during previous 3 months
• Patients who have any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol

Where it is running

• SF Research Institute, Inc. — San Francisco, California, United States

Full record on ClinicalTrials.gov

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