Health TrialsbyHealthPanel

Effects of Ashwagandha Extract on Stress Levels

ConditionStress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-59
SponsorNutraceuticals Research Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ashwagandha root

    Dietary supplement

    This substance is extracted from the root of the plant.

  • ashwagandha root and leaf

    Dietary supplement

    This substance is extracted from both the root and leaves of the plant.

  • placebo

    Other intervention

    The inert placebo does not contain any of the plant matter.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Plant Extract 1Experimental treatment 1 intervention
Group B: Plant Extract 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post-test Cortisol Awakening Response, after controlling for baseline scores

salivary cortisol levels will be taken immediately after waking and 30 minutes later to produce a composite score

Time frame
60 days
2

NRI-SS (Nutraceuticals Research Institute's Stress Scale)

This is a validated scale measuring 6 subdomains of stress. It is measured on a likert scale. Scores on each subdomain can range from 5 to 42, with higher scores indicating greater stress levels.

Time frame
60 days

Secondary outcomes

1

NRI-ES (Nutraceuticals Research Institute's Energy Scale)

This is a validated scale measuring 6 subdomains of energy. It is measured on a likert scale. Scores on each subdomain can range from 5 to 42, with higher scores indicating greater energy levels.

Time frame
60 days
2

NRI-Sleep (Nutraceuticals Research Institute's Sleep Scale)

This is a validated scale measuring 7 subdomains of sleep. It is measured on a likert scale. Scores on each subdomain can range from 5-42 with higher scores indicating greater quality of sleep

Time frame
60 days
3

NRI-Cognition Scale

This is a validated scale measuring 6 subdomains of cognition. It is measured on a likert scale. Scores on each subdomain can range from 5-42 with higher scores indicating greater quality of cognitive health

Time frame
60 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nutraceuticals Research Institute

Lead sponsor

Source ClinicalTrials.gov
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