The purpose of this project is to better understand the role of ashwagandha on the stress response and wellbeing among healthy, stressed women.
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
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
Parallel
Placebo
Other interventionBrown Rice Powder
KSM-66 Ashwagandha
Dietary supplement600mg daily KSM-66 Ashwagandha
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).
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).
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
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
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).
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
