The Impacts of Ashwagandha Supplementation on Diurnal Cortisol and Stress Among Women

NCT07647081 | Not Yet Recruiting

• 1 other identifier: 2025086
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this project is to better understand the role of ashwagandha on the stress response and wellbeing among healthy, stressed women.

Conditions

Stress

Keywords

stress; women; ashwagandha; cortisol; female

Outcome Measures

Primary Outcomes (2)

• Diurnal Salivary Cortisol Change from Baseline to ~4 weeks and ~8 weeks

  Saliva swabs from waking, 30 minutes post-waking, and bedtime will be analyzed to compare cortisol levels and diurnal changes across timepoints from baseline to \~4 weeks and \~8 weeks (as corresponding to participants menstrual cycle).

  Baseline, ~4 weeks,. ~8weeks

• HRV Change from Baseline to ~4 weeks and ~8 weeks

  Wearable biometric device data will be used to compare heart rate variability (HRV) from baseline to \~4 weeks and \~ 8 weeks (as corresponding to participants menstrual cycle).

  Baseline, ~4 weeks,. ~8weeks

Secondary Outcomes (5)

• Perceived Stress Scale (PSS)

  Baseline, ~4 weeks,. ~8weeks

• Hamilton Anxiety Rating Scale (HAM-A)

  Baseline, ~4 weeks,. ~8weeks

• Depression Anxiety Stress Scale-21 (DASS21)

  Baseline, ~4 weeks,. ~8weeks

• World Health Organization-Five Well-Being Index (WHO-5)

  Baseline, ~4 weeks,. ~8weeks

• Sleep Quality Change from Baseline to ~4 weeks and ~8 weeks

  Baseline, ~4 weeks,. ~8weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Brown Rice Powder

Other: Placebo

KSM-66 Ashwagandha

EXPERIMENTAL

600mg daily KSM-66 Ashwagandha

Dietary Supplement: KSM-66 Ashwagandha

Interventions

Placebo OTHER

Brown Rice Powder

Placebo

KSM-66 Ashwagandha DIETARY_SUPPLEMENT

600mg daily KSM-66 Ashwagandha

Also known as: withania somnifera, KSM66, KSM-66

KSM-66 Ashwagandha

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female, ages 18-45
• No hormonal birth control
• Identify as having a regular sleep schedule (eg. sleep by 1am and wake by 9am)
• Identify as having a regular menstrual period between 27-32 days apart on average
• PSS score of 14 (moderate stress) or greater
• No expected changes in stress levels over the next 3 months and agree to not initiate any new stress-reduction behaviors before study start or during the study

You may not qualify if:

• Diagnosed major depressive disorder or generalized anxiety disorder in the last 3 months, any liver, kidney, or thyroid disorder/dysfunction/injury, or diabetes
• Using any medication related to cortisol or HPA function such as corticosteroids, antidepressants, anti-psychotics, CNS-depressants (benzodiazepines, non-benzodiazepine sedatives, barbiturates, anti-convulsants, anesthetics), thyroid medications, diabetic medications, or immunosuppressants
• Taken any form of ashwagandha within the last 3 months
• Daily use of alcohol, nicotine, or other substances
• Who are pregnant, planning to become pregnant, breastfeeding, or have had a hysterectomy
• Abnormal liver function test value(s) at screening

Sponsors & Collaborators

• Oklahoma State University Center for Health Sciences: lead

Related Publications (6)

• Salve J, Pate S, Debnath K, Langade D. Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults: A Double-blind, Randomized, Placebo-controlled Clinical Study. Cureus. 2019 Dec 25;11(12):e6466. doi: 10.7759/cureus.6466.

  PMID: 32021735 BACKGROUND

• Remenapp A, Coyle K, Orange T, Lynch T, Hooper D, Hooper S, Conway K, Hausenblas HA. Efficacy of Withania somnifera supplementation on adult's cognition and mood. J Ayurveda Integr Med. 2022 Apr-Jun;13(2):100510. doi: 10.1016/j.jaim.2021.08.003. Epub 2021 Nov 25.

  PMID: 34838432 BACKGROUND

• Lopresti AL, Smith SJ, Malvi H, Kodgule R. An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract: A randomized, double-blind, placebo-controlled study. Medicine (Baltimore). 2019 Sep;98(37):e17186. doi: 10.1097/MD.0000000000017186.

  PMID: 31517876 BACKGROUND

• Gopukumar K, Thanawala S, Somepalli V, Rao TSS, Thamatam VB, Chauhan S. Efficacy and Safety of Ashwagandha Root Extract on Cognitive Functions in Healthy, Stressed Adults: A Randomized, Double-Blind, Placebo-Controlled Study. Evid Based Complement Alternat Med. 2021 Nov 30;2021:8254344. doi: 10.1155/2021/8254344. eCollection 2021.

  PMID: 34858513 BACKGROUND

• Choudhary D, Bhattacharyya S, Joshi K. Body Weight Management in Adults Under Chronic Stress Through Treatment With Ashwagandha Root Extract: A Double-Blind, Randomized, Placebo-Controlled Trial. J Evid Based Complementary Altern Med. 2017 Jan;22(1):96-106. doi: 10.1177/2156587216641830. Epub 2016 Apr 6.

  PMID: 27055824 BACKGROUND

• Chandrasekhar K, Kapoor J, Anishetty S. A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults. Indian J Psychol Med. 2012 Jul;34(3):255-62. doi: 10.4103/0253-7176.106022.

  PMID: 23439798 BACKGROUND

MeSH Terms

Interventions

Ashwagandha

Study Officials

• Julie Croff, PhD

  Oklahoma State University Center for Health Sciences

  PRINCIPAL INVESTIGATOR

• Erica Crockett, MPH

  Oklahoma State University Center for Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Scientist

CONTACT

918-517-6151; erica.crockett@okstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06