Effects of Ashwagandha Extract on Stress Levels

Nutraceuticals Research Institute

Status: Enrolling

Conditions: Stress

Treatments: Other: placebo; Dietary Supplement: ashwagandha root; Dietary Supplement: ashwagandha root and leaf

Study type: Interventional

Funder types: Other

Identifiers

NCT06793891

24-09-900

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on stress levels, with secondary outcomes of cognition, energy, and sleep, as compared to a placebo.

Full description

Participants will take one of two extracts or a placebo every day for 60 days; outcomes of stress, sleep, energy, and cognition will provide information on effectiveness.

Enrollment: 60 estimated patients

Sex: Female

Ages: 30 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed and dated informed consent form
• Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study
• Self reported high stress
• Baseline score of above-average stress levels on the NRI-SS
• Biological sex of woman; gender identification of female
• Aged 30 to 59, inclusive
• Good general health as evidenced by medical history and screening
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study
• Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion criteria

• Pregnancy, trying to conceive, or breastfeeding
• Currently smokes or vapes (i.e., tobacco, flavored items, marijuana, etc.) or has in the past year
• Consumes > 8 alcoholic beverages in an average week
• Is a primary caretaker for a child younger than 18 months of age
• Currently consumes an ashwagandha supplement or has consumed one regularly (defined as 1x week or more often) within the past 24 months
• Consumes any stress aid, medication, diet, or supplement intended to improve stress in any way
• Current or recent (within 60 days) history of taking thyroid medications, hypertensive drugs, CNS depressants, diabetic medications, benzodiazepines, or immunosuppressants
• Any liver or kidney disorder
• Known allergic reactions to any components of the intervention
• Positive COVID-19 test within 30 days of the study period
• Recent dramatic weight changes (10% change in body weight in the last 6 months)
• Introducing a new investigational drug or other intervention within 60 days before the start of the study
• Introducing a new lifestyle stress-reduction aid (i.e. physical activity, yoga, etc) within 60 days before the start of the study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 3 patient groups, including a placebo group

Plant Extract 1

Experimental group

Description:

Participants in this arm will take an ashwagandha root supplement each day for 60 days.

Treatment:

Dietary Supplement: ashwagandha root

Plant Extract 2

Experimental group

Description:

Participants in this arm will take an ashwagandha root and leaf supplement each day for 60 days.

Treatment:

Dietary Supplement: ashwagandha root and leaf

Placebo

Placebo Comparator group

Description:

Participants in this arm will take an inert placebo each day for 60 days.

Treatment:

Other: placebo