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

Part of paid clinical trials in San Francisco, California.

Sponsor
SF Research Institute, Inc.
Study ID
NCT06714942
Status
Recruiting
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Conditions

  • Anxiety
  • Stress

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Proprietary Blend of Ashwagandha — DIETARY_SUPPLEMENT
    One capsule (300mg) is taken twice daily with water
  • KSM-66 Ashwagandha root extract — DIETARY_SUPPLEMENT
    One capsule (300mg) is taken twice daily with water
  • Placebo — DIETARY_SUPPLEMENT
    One capsule (300mg) is taken twice daily with water

Study Details

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.

Key Dates

Start date
Oct 25, 2024
Status verified
Nov 2024
Primary completion
Dec 27, 2024
Completion
Jan 21, 2025

Study Design

Enrollment
51 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group
    One capsule of Proprietary Blend of Ashwagandha 300 mg twice a day, orally with water.
  • Experimental: Comparator Group
    One capsule of KSM-66 Ashwagandha 300mg two times a day, orally with water
  • Placebo Comparator: Control Group
    One capsule of Placebo two times a day, orally with water

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco Research InstituteSan FranciscoCalifornia94127
John Ademola

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San Francisco Research Institute· San Francisco, CA

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