Effects of an Ashwagandha extract on stress and energy in middle-to-older age adults with self-reported stress and energy problems
- Conditions
- High StressFatigueInflammationMental Health - Other mental health disordersAlternative and Complementary Medicine - Herbal remediesInflammatory and Immune System - Other inflammatory or immune system disorders
- Registration Number
- ACTRN12621001551886
- Lead Sponsor
- Clinical Research Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
1)Healthy males and females aged between 40 and 75 years
2)Subjective report of low energy by answering ‘yes’ to the following question: Do you experience low energy or fatigue?
3)Currently experiencing high stress (as determined by a PSS scale score of 14 or higher)
4)A score of 9 or more on the PROMIS-29 fatigue subscale score
5)Stressor/anxiety has been present for greater than a month
6)Non-smoker
7)BMI between 25 and 35 kg/m2
8)Medication free over the previous 3 months
9)No plan to commence new treatments over the study period
10)No plan to change diet or physical activity or other significant lifestyle changes over the study period
11)Understand, willing, and able to comply with all study procedures
12)Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
1)Anticipated major stressor, change or medical procedure occurring during the study period likely to affect psychological or physical status
2)Blood profile (comprising complete blood count, liver function test, renal function test, and thyroid-stimulating hormone) containing elevated markers suggestive of a clinical condition/ disease and requiring further medical assessment.
3)Suffering from a diagnosed medical condition including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, a gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, endocrine disease, renal disease, hepatic disease, genital anatomical deformities, abnormal secondary sexual characteristics, spinal cord injury, benign prostatic hypertrophy, acute genitourinary disorder or history of genital surgery, acute or chronic pain condition, or cancer/malignancy
4)Diagnosis of neurological or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury
5)Diagnosed erectile dysfunction or any physical disability that may limit sexual function
6)Taking vitamins or herbal supplements that are reasonably expected to influence study measures
7)Current or 12-month history of illicit drug abuse
8)Regular medication intake including but not limited to anticholinergics, acetylcholinesterase inhibitors, testosterone replacement therapy, levodopa, calcipotriene, or steroid medications
9)Change in medication in the last 3 months or an expectation to change during the study duration
10)Alcohol intake greater than 14 standard drinks per week
11)Pregnant women, women who are breastfeeding or women who intended to fall pregnant.
12)Any significant surgeries over the last year
13)History of hypersensitivity to herbs, spices, or dietary supplement
14)Planned major lifestyle change in the next 3 months
15)Participation in any other clinical trial in the last 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the Perceived Stress Scale[ Day 0, weeks 4, 8, and 12 (primary endpoint) post-intervention commencement]
- Secondary Outcome Measures
Name Time Method