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 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.

Study Overview

• Status: Recruiting
• Conditions: Stress; Anxiety
• Intervention / Treatment: Dietary supplement: Proprietary Blend of Ashwagandha; Dietary supplement: KSM-66 Ashwagandha root extract; Dietary supplement: Placebo

Detailed Description

To qualify for the study, participants must be aged between 18 to 55 years 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.).

In this study, a maximum of 51 patients will be enrolled and the goal is to complete the study with at least 45 patients.

After signing this consent form, participants will answer questions regarding their medical history, including any medications they are taking. Physical exams with vital signs (pulse, temperature, sitting blood pressure and respiratory rate) will be performed at both visits by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist, or Medical Doctor.

A blood sample will be required from subjects. Subject's right or left arm will be used as the blood draw site, requiring a 5mL sample.e blood will be analyzing Cortisol level. These blood draws will be administered by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist or Medical Doctor.

A two-page Hamilton Anxiety Rating Scale (HAM-A) Test and Perceived Stress Scale (PSS) will be given and administered as self-assessment.

All eligible participants, will be given the required quantity of the study medication for self-administration, sufficient till the Visit 3- End of study visit, 8 weeks ± 4 Days. Participants will be randomized to either one of the three treatment arms.

Participants will be instructed to take one capsule of study medication to which they are randomized twice daily, with ambient temperature water for 8 weeks at home. Participants will be asked to visit the site for Visit 2 (4 weeks ± 4 Days), Visit 3 (8 weeks ± 4 Days). Adverse events and concomitant medication will be recorded throughout the study. Participants will be asked to get used and unused study medications and their subject diaries in this visit. All the participants will be asked to continue their routine diet and physical activities during the whole study period.

The primary end point is mean change in serum cortisol level from baseline. The secondary end points are Perceived Stress Scale (PSS) questionnaire, Hamilton Anxiety Rating Scale (HAM-A) questionnaire, Profile of Mood States (POMS, abbreviated version) questionnaire, Oxford Happiness Questionnaire from baseline. The safety end points are the Number and proportion of Treatment-Emergent Adverse Events (TEAEs) over 8 weeks and the Number and proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 8 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Ademola; Phone Number: +1 (415) 845-4638; Email: jademola@sfinstitute.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94127
      • Recruiting
      • San Francisco Research Institute
      • Contact: John Ademola

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; One capsule of Placebo two times a day, orally with water	Dietary supplement: Placebo; One capsule (300mg) is taken twice daily with water
Experimental: Treatment Group; One capsule of Proprietary Blend of Ashwagandha 300 mg twice a day, orally with water.	Dietary supplement: Proprietary Blend of Ashwagandha; One capsule (300mg) is taken twice daily with water
Experimental: Comparator Group; One capsule of KSM-66 Ashwagandha 300mg two times a day, orally with water	Dietary supplement: KSM-66 Ashwagandha root extract; One capsule (300mg) is taken twice daily with water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum cortisol level	Blood samples for serum cortisol will be collected at Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) and Visit 3- (Week 8)]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale Score (PSS)	The Perceived Stress Scale (PSS-10) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. The questions in the PSS ask about feelings and thoughts during the last month.	PSS assessment will be done at Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4), and Visit 3 (Week 8).
Hamilton Anxiety Rating Scale (HAM-A)	The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms and is still widely used today in both clinical and research settings. The HAM-A scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.	HAM-A assessment will be done at Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4), and Visit 3 (Week 8).
Profile of Mood States (POMS, abbreviated version)	The POMS is a 40-item questionnaire rated on a 5-point Likert Scale, asking respondents how they feel right now. Scores are calculated for Tension, Anger, Fatigue, Depression, Esteem-related affect, Vigor, Confusion, and Total Mood Disturbance.	POMS assessment will be done at Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4), and Visit 3 (Week 8).
Oxford Happiness Questionnaire	The Oxford Happiness Scale (OHS) is a psychological assessment tool designed to measure an individual's subjective level of happiness. It was developed by researchers Michael Argyle and Peter Hills at the University of Oxford. The scale is widely used in positive psychology and well-being research to evaluate happiness as a multidimensional concept, encompassing emotional, cognitive, and social aspects.	Oxford Happiness Questionnaire assessment will be done at Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4), and Visit 3 (Week 8).

Collaborators and Investigators

• Sponsor: SF Research Institute, Inc.
• Collaborators: Agaja Pharma Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2024
• Primary Completion (Estimated): December 27, 2024
• Study Completion (Estimated): January 21, 2025

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: December 1, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 1, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: AGJ-1051-2023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No