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

NCT06714942 | Recruiting

• 1 other identifier: AGJ-1051-2023-01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Perceived Stress Scale Score (PSS)

  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)

  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)

  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

  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).

Study Arms (3)

Treatment Group

EXPERIMENTAL

One capsule of Proprietary Blend of Ashwagandha 300 mg twice a day, orally with water.

Dietary Supplement: Proprietary Blend of Ashwagandha

Comparator Group

EXPERIMENTAL

One capsule of KSM-66 Ashwagandha 300mg two times a day, orally with water

Dietary Supplement: KSM-66 Ashwagandha root extract

Control Group

PLACEBO COMPARATOR

One capsule of Placebo two times a day, orally with water

Dietary Supplement: Placebo

Interventions

Proprietary Blend of Ashwagandha DIETARY_SUPPLEMENT

One capsule (300mg) is taken twice daily with water

Treatment Group

KSM-66 Ashwagandha root extract DIETARY_SUPPLEMENT

One capsule (300mg) is taken twice daily with water

Comparator Group

Placebo DIETARY_SUPPLEMENT

One capsule (300mg) is taken twice daily with water

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (male and female) aged between 18 and 65 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.).
• Hamilton Anxiety Rating Scale (HAM-A) total score between 14 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.
• 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.
• 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 a total score of 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 a depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia, and mania.
• Patients with known post-traumatic stress disorder (PTSD) and Generalized Anxiety Disorder (GAD).
• 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 a history of alcohol, tobacco dependence, or 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 the previous 3 months.
• Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.

Sponsors & Collaborators

• SF Research Institute, Inc.: lead
• Agaja Pharma Pvt. Ltd.: collaborator

Study Sites (1)

San Francisco Research Institute

San Francisco, California, 94127, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

John Ademola

CONTACT

+1 (415) 845-4638; jademola@sfinstitute.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 4, 2024
• Study Start: October 25, 2024
• Primary Completion: December 27, 2024
• Study Completion: January 21, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

US (1)