StressNCT06793891
Effects of Ashwagandha Extract on Stress Levels
A study testing ashwagandha root and ashwagandha root and leaf in people with Stress, run by Nutraceuticals Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- ashwagandha root and ashwagandha root and leaf
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2024to 30 Apr 2025
- 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 30 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nutraceuticals Research Institute
Huntsville, Alabama, 35801
JESSIE HAWKINS, PhD, 256-203-9010, j.hawkins@nutraceuticalsresearch.com
About this study
Official title: The Effectiveness of a Proprietary Ashwagandha Extract on Stress Reduction: A Three-Arm Randomized, Double-Blinded, Placebo Controlled Clinical 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.
Read the detailed 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.
- Conditions
- Stress
- Being tested
- ashwagandha root, ashwagandha root and leaf, placebo
- Keywords
- energy, fatigue, cognition, nutraceuticals, Ashwagandha
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ashwagandha rootDietary supplement
This substance is extracted from the root of the plant.
ashwagandha root and leafDietary supplement
This substance is extracted from both the root and leaves of the plant.
placeboOther
The inert placebo does not contain any of the plant matter.
| Study group | Role | What they receive |
|---|---|---|
| Plant Extract 1 | Experimental | Participants in this arm will take an ashwagandha root supplement each day for 60 days. Receives: Dietary Supplement: ashwagandha root |
| Plant Extract 2 | Experimental | Participants in this arm will take an ashwagandha root and leaf supplement each day for 60 days. Receives: Dietary Supplement: ashwagandha root and leaf |
| Placebo | Placebo comparator | Participants in this arm will take an inert placebo each day for 60 days. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 days
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.
Measured: 60 days
Secondary outcomes (3)
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.
Measured: 60 days
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
Measured: 60 days
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
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start21 Oct 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessie Hawkins, Nutraceuticals Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793891
- Sponsor's protocol ID
- 24-09-900
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Consent to share IPD will not been obtained from participants.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Proprietary Ashwagandha Extract on Stress Reduction: A Three-Arm Randomized, Double-Blinded, Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06793891
- Acronym / sponsor ID
- 24-09-900
- Conditions
- Stress
- Keywords
- energy, fatigue, cognition, nutraceuticals, Ashwagandha
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 27 Jan 2025 (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 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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Plant Extract 1 | Experimental | Dietary Supplement: ashwagandha rootParticipants in this arm will take an ashwagandha root supplement each day for 60 days. |
| Plant Extract 2 | Experimental | Dietary Supplement: ashwagandha root and leafParticipants in this arm will take an ashwagandha root and leaf supplement each day for 60 days. |
| Placebo | Placebo comparator | Other: placeboParticipants in this arm will take an inert placebo each day for 60 days. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| ashwagandha rootThis substance is extracted from the root of the plant. | Dietary supplement | Plant Extract 1 |
| ashwagandha root and leafThis substance is extracted from both the root and leaves of the plant. | Dietary supplement | Plant Extract 2 |
| placeboThe inert placebo does not contain any of the plant matter. | Other | Placebo |
Primary outcome
Post-test Cortisol Awakening Response, after controlling for baseline scores
Time frame: 60 days
salivary cortisol levels will be taken immediately after waking and 30 minutes later to produce a composite score
NRI-SS (Nutraceuticals Research Institute's Stress Scale)
Time frame: 60 days
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.
3 secondary outcomes
NRI-ES (Nutraceuticals Research Institute's Energy Scale)
Time frame: 60 days
NRI-Sleep (Nutraceuticals Research Institute's Sleep Scale)
Time frame: 60 days
NRI-Cognition Scale
Time frame: 60 days
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 27 Jan 2025.
- Individual participant dataSharing planned: No. Consent to share IPD will not been obtained from participants.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ashwagandha root and ashwagandha root and leaf in people with Stress, run by Nutraceuticals Research Institute at 1 site in United States.
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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jessie Hawkins, PhD (256-203-9010, j.hawkins@nutraceuticalsresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-test Cortisol Awakening Response, after controlling for baseline scores (time frame: 60 days). 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?
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 27 Jan 2025.