Menopausal Hot FlashesNCT07210229
The Effectiveness of a Proprietary Ashwagandha Extract on Menopausal Symptoms: A Three-Arm Randomized, Double-Blinded, Placebo Controlled Clinical Trial
A study testing ashwagandha root and ashwagandha root and leaf in people with Menopausal Hot Flashes and Menopausal Women, 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 symptoms of menopause and hormone levels, as compared to a placebo. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Menopausal Hot Flashes, Menopausal Women
- 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
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 30 Mar 2026
- 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 40 to 55 years
- Women only
- No healthy volunteers
- 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
- Baseline score of above-average menopause symptom levels on each of the patient reported scales: NRI-MSS (defined as 22+), the MRS scale (defined as 9+), AND 4+ on the MENQoL.
- Confirmation of presence of hot flashes
- Estridiol levels within the bottom 35% of normal ranges for their menstrual cycle phase (follicular/ovulation/luteal) as established by laboratory reference range
- Biological sex of female; gender identification of woman
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- Aged 40 to 55, 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
- Still menstruating regularly (defined at least one period every 60 days)
- Agreement to adhere to Lifestyle Considerations throughout study duration
Who cannot join
- Pregnant, trying to conceive, or breastfeeding
- Hysterectomy, uterine ablation, or related procedure
- Amenorrhea
- Consumes > 8 alcoholic beverages in an average week
- Currently consumes an ashwagandha supplement or has consumed one regularly (defined as 1x week or more often) within the past 24 months
- Consumes any hormonal therapies or menopause-related supplements intended to improve symptoms 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, kidney, hormonal, or cardiovascular disorder
- Known allergic reactions to any components of the intervention
- 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
- Any change to diet or lifestyle within 60 days before the start of the study (defined as introducing any new exercise activity, joining a gym, starting a new routine, moving to a new home, adjusting dietary habits (e.g. vegetarian, paleo, etc) or discontinuing any habits or diets.
- Any health or medical condition which, in the primary investigators opinion, may interfere with the conduct 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
Nutraceuticals Research Institute
Huntsville, Alabama, 35801
Jessie Cavanaugh, PhD, 256-203-9010, j.cavanaugh@nutraceuticalsresearch.com
About this study
The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on symptoms of menopause and hormone levels, as compared to a placebo.
Read the detailed description
Participants will take one of two extracts or a placebo every day for 84 days; outcomes of self-report menopausal symptoms collected on a trio of scales will provide information on effectiveness.
- Conditions
- Menopausal Hot Flashes, Menopausal Women
- Being tested
- ashwagandha root, ashwagandha root and leaf, Placebo
- Keywords
- ashwagandha
- Medical subject headings
- Hot Flashes
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 84 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 84 days. Receives: Dietary Supplement: ashwagandha root and leaf |
| Placebo | Placebo comparator | Participants in this arm will take an inert placebo each day for 84 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proprietary Menopause Symptom Scale (NRI-MSS)
Nutraceuticals Research Institute's Menopause Symptom Scale is a validated self-report scale measuring symptoms across 6 domains. Scores range from 0-30, with higher scores indicating greater symptom severity.
Measured: days 0, 28, 56, and 84
Menopause-Specific Quality of Life (MenQoL)
The MenQoL evaluates quality of life among menopausal women. Scores range from 0-8 with higher scores indicating greater symptom severity.
Measured: days 0, 28, 56, and 84
Menopause Rating Scale (MRS)
The MRS is a self report assessment of menopausal symptoms with scores ranging from 0-44. Higher scores indicate greater symptom severity.
Measured: Days 0, 28, 56, and 84
Secondary outcomes (2)
Estriol
Laboratory test for estriol levels
Measured: days 0, 84
Estradiol
Laboratory test for estradiol levels
Measured: days 0, 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal Hot FlashesStudies 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, Investigator
- Enrolment
- 90 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
- NCT07210229
- Sponsor's protocol ID
- 25-08-200
- Status last verified
- Aug 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available with IRB authorization and consent from all participants.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Proprietary Ashwagandha Extract on Menopausal Symptoms: A Three-Arm Randomized, Double-Blinded, Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07210229
- Acronym / sponsor ID
- 25-08-200
- Conditions
- Menopausal Hot Flashes, Menopausal Women
- Keywords
- ashwagandha
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 7 Oct 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 symptoms of menopause and hormone levels, as compared to a placebo.
Detailed description
Participants will take one of two extracts or a placebo every day for 84 days; outcomes of self-report menopausal symptoms collected on a trio of scales will provide information on effectiveness.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- 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 84 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 84 days. |
| Placebo | Placebo comparator | Other: PlaceboParticipants in this arm will take an inert placebo each day for 84 days. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 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
- Baseline score of above-average menopause symptom levels on each of the patient reported scales: NRI-MSS (defined as 22+), the MRS scale (defined as 9+), AND 4+ on the MENQoL.
- Confirmation of presence of hot flashes
- Estridiol levels within the bottom 35% of normal ranges for their menstrual cycle phase (follicular/ovulation/luteal) as established by laboratory reference range
Key exclusion criteria (13 listed)
- Pregnant, trying to conceive, or breastfeeding
- Hysterectomy, uterine ablation, or related procedure
- Amenorrhea
- Consumes > 8 alcoholic beverages in an average week
- 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
Proprietary Menopause Symptom Scale (NRI-MSS)
Time frame: days 0, 28, 56, and 84
Nutraceuticals Research Institute's Menopause Symptom Scale is a validated self-report scale measuring symptoms across 6 domains. Scores range from 0-30, with higher scores indicating greater symptom severity.
Menopause-Specific Quality of Life (MenQoL)
Time frame: days 0, 28, 56, and 84
The MenQoL evaluates quality of life among menopausal women. Scores range from 0-8 with higher scores indicating greater symptom severity.
Menopause Rating Scale (MRS)
Time frame: Days 0, 28, 56, and 84
The MRS is a self report assessment of menopausal symptoms with scores ranging from 0-44. Higher scores indicate greater symptom severity.
2 secondary outcomes
Estriol
Time frame: days 0, 84
Estradiol
Time frame: days 0, 84
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 7 Oct 2025.
- Individual participant dataSharing planned: No. Data is available with IRB authorization and consent from all 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 Menopausal Hot Flashes and Menopausal Women, 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 11 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: opening soon, as of the sponsor's last update on 7 Oct 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 Cavanaugh, PhD (256-203-9010, j.cavanaugh@nutraceuticalsresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proprietary Menopause Symptom Scale (NRI-MSS) (time frame: days 0, 28, 56, and 84). The study lists 3 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 7 Oct 2025.