StressFAB:SRNCT07647081
The Impacts of Ashwagandha Supplementation on Diurnal Cortisol and Stress Among Women
A study testing KSM-66 Ashwagandha in people with Stress, run by Oklahoma State University Center for Health Sciences.
Trial summary
The purpose of this project is to better understand the role of ashwagandha on the stress response and wellbeing among healthy, stressed women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- KSM-66 Ashwagandha
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Female Adversity and Biology: Stress Reduction
The purpose of this project is to better understand the role of ashwagandha on the stress response and wellbeing among healthy, stressed women.
Read the detailed description
This study will add knowledge about how ashwagandha can impact diurnal cortisol values (at waking, 30 minutes-post waking, and bedtime). This study will also assess the impact of ashwagandha consumption on inflammatory biomarkers and self-reported perceived stress, anxiety, and well-being among females.
- Conditions
- Stress
- Being tested
- Placebo, KSM-66 Ashwagandha
- Keywords
- stress, women, ashwagandha, cortisol, female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Brown Rice Powder
KSM-66 AshwagandhaDietary supplement
Also called withania somnifera, KSM66, KSM-66
600mg daily KSM-66 Ashwagandha
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Brown Rice Powder Receives: Other: Placebo |
| KSM-66 Ashwagandha | Experimental | 600mg daily KSM-66 Ashwagandha Receives: Dietary Supplement: KSM-66 Ashwagandha |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline, ~4 weeks,. ~8weeks
Secondary outcomes (5)
Perceived Stress Scale (PSS)
Perceived Stress Scale (PSS) data will be used to compare changes from baseline to ~4 weeks and ~ 8 weeks (as corresponding to participants menstrual cycle).
Individual scores can range from 0 to 40 with higher scores correlating with higher levels of perceived stress.
0-13: Low Stress 14-26: Moderate Stress 27-40: High Perceived Stress
Measured: Baseline, ~4 weeks,. ~8weeks
Hamilton Anxiety Rating Scale (HAM-A)
Hamilton Anxiety Rating Scale (HAM-A) data will be used to compare changes from baseline to ~4 weeks and ~ 8 weeks (as corresponding to participants menstrual cycle).
Each item is scored on a scale of 0 (not present) to 4 (severe). Total scores range of 0-56.
0-17: Mild severity 18-24: Mild to moderate severity 25-30: Moderate to severe
Measured: Baseline, ~4 weeks,. ~8weeks
Depression Anxiety Stress Scale-21 (DASS21)
Depression Anxiety Stress Scale-21 (DASS21) data will be used to compare subset scales for depression, anxiety and stress changes from baseline to ~4 weeks and ~ 8 weeks (as corresponding to participants menstrual cycle).
DASS21 is a set of three scales designed to measure the emotional states of depression, anxiety and stress. Scores can range from normal to extremely severe for each domain.
Each item is scored on a scale of 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time).
Measured: Baseline, ~4 weeks,. ~8weeks
World Health Organization-Five Well-Being Index (WHO-5)
World Health Organization-Five Well-Being Index (WHO-5) data will be used to compare mental wellbeing changes from baseline to ~4 weeks and ~ 8 weeks (as corresponding to participants menstrual cycle).
Each item is scored on a scale of 0 (at no time) to 5 (all of the time). Total scores range from 0 to 25. With 0 representing worst possible and 25 representing best possible quality of life.
Measured: Baseline, ~4 weeks,. ~8weeks
Sleep Quality Change from Baseline to ~4 weeks and ~8 weeks
Wearable biometric device data will be used to compare sleep quality, latency, and duration from baseline to ~4 weeks and ~ 8 weeks (as corresponding to participants menstrual cycle).
Measured: Baseline, ~4 weeks,. ~8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erica Crockett, Oklahoma State University Center for Health Sciences
- Investigators
- Julie Croff, PhD, Principal investigator, Oklahoma State University Center for Health SciencesErica Crockett, MPH, Principal investigator, Oklahoma State University Center for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647081
- Sponsor's protocol ID
- 2025086
- Acronym
- FAB:SR
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD has not been discussed or decided upon for this study yet.
Publications
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.
PubMed 32021735Remenapp 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.
PubMed 34838432Lopresti 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.
PubMed 31517876Gopukumar 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.
PubMed 34858513Choudhary 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.
PubMed 27055824Chandrasekhar 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.
PubMed 23439798
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female Adversity and Biology: Stress Reduction
- ClinicalTrials.gov ID
- NCT07647081
- Acronym / sponsor ID
- FAB:SR / 2025086
- Conditions
- Stress
- Keywords
- stress, women, ashwagandha, cortisol, female
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to better understand the role of ashwagandha on the stress response and wellbeing among healthy, stressed women.
Detailed description
This study will add knowledge about how ashwagandha can impact diurnal cortisol values (at waking, 30 minutes-post waking, and bedtime). This study will also assess the impact of ashwagandha consumption on inflammatory biomarkers and self-reported perceived stress, anxiety, and well-being among females.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboBrown Rice Powder |
| KSM-66 Ashwagandha | Experimental | Dietary Supplement: KSM-66 Ashwagandha600mg daily KSM-66 Ashwagandha |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboBrown Rice Powder | Other | Placebo |
| KSM-66 AshwagandhaAlso: withania somnifera, KSM66, KSM-66600mg daily KSM-66 Ashwagandha | Dietary supplement | KSM-66 Ashwagandha |
Primary outcome
Diurnal Salivary Cortisol Change from Baseline to ~4 weeks and ~8 weeks
Time frame: Baseline, ~4 weeks,. ~8weeks
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).
HRV Change from Baseline to ~4 weeks and ~8 weeks
Time frame: Baseline, ~4 weeks,. ~8weeks
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).
5 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: Baseline, ~4 weeks,. ~8weeks
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Baseline, ~4 weeks,. ~8weeks
Depression Anxiety Stress Scale-21 (DASS21)
Time frame: Baseline, ~4 weeks,. ~8weeks
World Health Organization-Five Well-Being Index (WHO-5)
Time frame: Baseline, ~4 weeks,. ~8weeks
Sleep Quality Change from Baseline to ~4 weeks and ~8 weeks
Time frame: Baseline, ~4 weeks,. ~8weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 32021735Salve 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.
- Background: PubMed 34838432Remenapp 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.
- Background: PubMed 31517876Lopresti 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.
- Background: PubMed 34858513Gopukumar 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.
- Background: PubMed 27055824Choudhary 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.
- Background: PubMed 23439798Chandrasekhar 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.
- Individual participant dataSharing planned: Undecided. IPD has not been discussed or decided upon for this study yet.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Croff, PhD principal investigator
Oklahoma State University Center for Health Sciences
Erica Crockett, MPH principal investigator
Oklahoma State University Center for Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing KSM-66 Ashwagandha in people with Stress, run by Oklahoma State University Center for Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Scientist (918-517-6151, erica.crockett@okstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diurnal Salivary Cortisol Change from Baseline to ~4 weeks and ~8 weeks (time frame: Baseline, ~4 weeks,. ~8weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07647081, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.