RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-25

Study Completion:2025-01-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06714942

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

John Ademola

CONTACT

+1 (415) 845-4638

jademola@sfinstitute.com

Study Locations (Sites)

San Francisco Research Institute

San Francisco, California, 94127

United States

Collaborators and Investigators

Sponsor: SF Research Institute, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-25

Study Completion Date2025-01-21

Study Record Updates

Study Start Date2024-10-25

Study Completion Date2025-01-21

Terms related to this study

Additional Relevant MeSH Terms

Stress
Anxiety